Sekisui

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Catalent Biologics Completes Madison Expansion

More than doubles overall CGMP-scale capacity increasing the number of manufacturing suites at the site to five.

Kristin Brooks 04.13.21

Drug Delivery | Logistics | Vials

Vetter Packaging Solutions

Vetter can help you identify and develop the right packaging strategies for your compound, from clinical dev to commercialization to life cycle management.

Breaking News | Facilities | Industry News | Solid Dosage/Creams/Ointments

Bora Pharmaceuticals Adds Roller Compaction Capabilities

Installed at Zhunan, Taiwan facility known for manufacturing complex oral solid dose formulations.

Tim Wright, Editor, Contract Pharma 04.09.21

Breaking News | Promotions & Moves

AGC Biologics Appoints Jun Takami GM of Chiba Site

Mr. Takami brings more than 15 years of experience in the pharmaceutical industry.

Kristin Brooks 04.08.21

Analytical Services | Bioanalytical Services | Breaking News | Industry News

Agilex Biolabs Acquires TetraQ for APAC Expansion Plans

Specializes in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarker and immunological pharmacodynamics assessments.

Kristin Brooks 04.08.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Fill/Finish | Industry News

Moderna, Catalent Enter Long-Term Strategic Vax Pact

Catalent to dedicate a new high-speed vial filling line for the manufacture of the Moderna COVID-19 Vaccine and potentially other investigational programs.

Kristin Brooks 04.06.21

Bioanalytical Services | Breaking News | CRO News | Industry News

Charles River Acquires Retrogenix

Strengthens scientific expertise with the addition of cell microarray technology and off-target profiling for drug discovery.

Tim Wright, Editor, Contract Pharma 04.05.21

Drug Delivery

The Ever-Evolving World of Combination Products

Looking at the benefits and challenges of the trend towards combination products.

Ricki A. Chase, M.S, Lachman Consultants 04.01.21

Breaking News | Industry News

SK Capital Completes Acquisition of BFS from Catalent Pharma Solutions

Renames the business to Woodstock Sterile Solutions.

Charles Sternberg, Assistant Editor 03.31.21

Breaking News | Industry News | Promotions & Moves

Vibalogics Updates U.S. Leadership Team

Appoints new CFO, VP of quality and head of process sciences.

Charles Sternberg, Assistant Editor 03.31.21

Chime Biologics Expands CDMO Capabilities

Completes $190 million financing round to accelerate capacity expansion.

Tim Wright, Editor, Contract Pharma 03.29.21

Genopis Renamed Wacker Biotech US

Plasmid DNA contract manufacturer was recently acquired by Wacker.

Tim Wright, Editor, Contract Pharma 03.19.21

Breaking News | Industry News | Promotions & Moves

Alcami Names Patrick D. Walsh as Chairman and CEO

35-year pharmaceutical industry veteran brings deep industry expertise and a track record of building successful, client-centric, growth organizations.

Tim Wright, Editor, Contract Pharma 03.19.21

WuXi Biologics to Acquire CMAB Biopharma Group

Will increase 7000L drug substance capacity (MFG21) and drug product capacity (DP11) for liquid and lyophilization within its global manufacturing network.

Kristin Brooks 03.18.21

Promotions & Moves

Alcami Appoints Patrick D. Walsh as Chairman and Chief Executive Officer

He succeeds Walter J. Kaczmarek III, who is stepping down as Chief Executive Officer.

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Catalent Expands Partnership with J&J

To significantly increase capacity for sterile manufacturing and packaging of COVID-19 vaccine in Italy.

Tim Wright, Editor, Contract Pharma 03.17.21

WuXi Biologics to Acquire Manufacturing Facilities from Pfizer China

Immediately boosts commercial Drug Substance and Drug Product capacities for WuXi Biologics to address surging manufacturing demands.

Tim Wright, Editor, Contract Pharma 03.17.21

Breaking News | Promotions & Moves

Univercells Technologies Names CEO

Mathias Garny to lead the growth and commercialization strategy for biomanufacturing product portfolio and new technology developments.

Kristin Brooks 03.16.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

BioVaxys, Wuxi Biologics Enter Bioproduction Agreement

To synthesize proteins for SARS-CoV-2 vaccine and COVID-T immunodiagnostic programs.

Tim Wright, Editor, Contract Pharma 03.15.21

Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News

Jubilant HollisterStier, Lilly Enter Bamlanivimab Mfg. Pact

COVID-19 therapy Bamlanivimab will be manufactured at Jubilant HollisterStier's Spokane, WA facility.

03.09.21

Bio News | Breaking News | Industry News

Cytovance Biologics Offers Licensing for Plasmid DNA Manufacturing

The Keystone Expression System pDNA platform is an end-to-end solution for manufacturing GMP pDNA at scale.

Tim Wright, Editor, Contract Pharma 03.09.21

Baxter Biopharma Enters Sterile Manufacturing Agreement for Novavax’ COVID-19 Vaccine

Manufacturing to take place at Baxter’s state-of-the-art Halle/Westfalen, Germany facility.

Tim Wright, Editor, Contract Pharma 03.09.21

Breaking News | Collaborations & Alliances

Iontas and Fair Journey Biologics Partner with Quell Therapeutics

Novel target binders from Iontas/FJB will be used to uncover functional antibodies to advance Quell’s engineered Treg cell therapy pipeline.

Charles Sternberg, Assistant Editor 03.08.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

AGC Biologics Expands Cell and Gene Facility in Italy

Plans call for increased capacities and viral vector suspension capabilities at Milan site.

Tim Wright, Editor, Contract Pharma 03.05.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Pharmaron Acquires Biomanufacturing Site in the UK from AbbVie

Continues to build integrated capabilities platform for cell and gene therapy.

Tim Wright, Editor, Contract Pharma 03.05.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Fujifilm Breaks Ground on Major Expansion of Biologics Facility in Denmark

Virtual ground-breaking ceremony celebrates initiation of expansion to double cell culture capacity and add large scale fill/finish capabilities.

Tim Wright, Editor, Contract Pharma 03.05.21

Innoforce and dMed Enter Development Collaboration

Aims to accelerate the development of innovative therapeutics.

Tim Wright, Editor, Contract Pharma 03.03.21

Information Technology

5 Reasons Paper Has No Place in Contract Manufacturing

Digital solutions create more efficient manufacturing processes and eliminate delays.

Dave Edwards, Chief Revenue Officer, MasterControl 03.01.21

Drug Delivery | Parenterals

Injectable Drug Delivery Trends

How medication trends are driving the shift to patient-friendly drug delivery systems.

Peter Soelkner, Managing Director, Vetter 03.01.21

Cold Chain Management | Logistics | Packaging & Tracking | Supply Chain

Reshaping the Pharmaceutical Supply Chain

The pandemic and COVID-19 vaccines bring navigating the cold-chain and preserving precious biologics to the forefront.

Kristin Brooks, Managing Editor 03.01.21

Breaking News | Industry News

J&J’s Single-Dose COVID-19 Vax Issued EUA

Phase 3 ENSEMBLE study demonstrated the vaccine was 85 percent effective in preventing severe disease.

Kristin Brooks 03.01.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

BMS Expands Cell Therapy Manufacturing Capabilities

New state-of-the-art cell therapy manufacturing facility under construction to expand global footprint.

Tim Wright, Editor, Contract Pharma 03.01.21

Catalent Acquires Delphi Genetics

Launches US plasmid manufacturing site to establish global pDNA development and manufacturing capabilities.

Tim Wright, Editor, Contract Pharma 02.23.21

Vetter continues its successful performance at the 2021 CMO Leadership Awards

Winning five core categories reaffirms Vetter as a trusted solution provider, particularly during globally challenging times.

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Avid Bioservices Begins Phase 2 of Myford Mfg. Expansion

Build to include second manufacturing train with both upstream and downstream processing suites.

Kristin Brooks 02.22.21

Drug Development

Embedding Your Drug Strategy Within a Solid Foundation for Success

This whitepaper looks at the broad set of trends inﬂuencing pharmaceutical development and manufacturing strategy today.

APIs | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

FUJIFILM Diosynth Hosts UK PM at COVID Vax Mfg. Site

Billingham site to support the manufacture of up to 180 million doses Novavax’ NVX-CoV2373 COVID-19 vaccine candidate.

Kristin Brooks 02.16.21

Breaking News | cGMP Manufacture | Industry News | Supply Chain

PwC Joins Medicines Manufacturing Innovation Centre

Joins founding partners to address challenges and maximize technology opportunities in the pharmaceutical supply chain.

Kristin Brooks 02.11.21

Breaking News | Industry News

Lonza to Divest Specialty Ingredients Biz

Allows Lonza to focus on its position in the healthcare industry and to accelerate strategic priorities.

Kristin Brooks 02.09.21

Thermo Fisher, JW Therapeutics Form CAR-T Partnership in China

Companies join forces in cell therapy applications and commercial-scale manufacturing.

Tim Wright, Editor, Contract Pharma 02.08.21

Argonaut Opens Custom Controls and Standards Facility

Formulation and filling will be performed at a state-of-the-art site in Carlsbad, CA.

Tim Wright, Editor, Contract Pharma 02.08.21

Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Vigene Plans Major Expansion in Maryland

Global gene therapy and vaccine manufacturing company taking additional space in Rockville and adding up to 245 jobs.

Tim Wright, Editor, Contract Pharma 02.08.21

Aseptic Processing | Breaking News | Industry News

Cytiva Acquires Canadian Aseptic Filling Innovator

Deal for Vanrx Pharmasystems supports global trends towards smaller manufacturing and the advent of personalized therapies.

Tim Wright, Editor, Contract Pharma 02.08.21

Catalent, Trizell Enter Cell Therapy Deal

Sign development and manufacturing agreement with for macrophage-based advanced cell therapy.

Tim Wright, Editor, Contract Pharma 02.08.21

Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development

The Future of Vaccines and Biologics

Dr. Linda Marbán of Capricor Therapeutics discusses the advances in responding to infectious diseases.

Kristin Brooks, Managing Editor, Contract Pharma 02.04.21

Breaking News | cGMP Manufacture

CSafe Global Expands in Asia

Opens two new hub operations in Beijing and Guangzhou, China.

Charles Sternberg, Assistant Editor 02.03.21

Immunome, Abzena Enter COVID-19 Antibody Cocktail Agreement

Abzena will work with Immunome to produce the antibody cocktail for clinical testing.

Kristin Brooks 02.03.21

Cognate BioServices, Nucleus Biologics Form Cell & Gene Therapy Partnership

Will focus on clinical and commercial clients, especially as Cognate expands its business with allogeneic and autologous on-demand cell and gene therapies.

Tim Wright, Editor, Contract Pharma 01.29.21

Novartis Inks Contract Manufacturing Deal for Pfizer-BioNTech COVID-19 Vaccine

Novartis to leverage manufacturing capacity and capabilities to address pandemic, supporting global supply of COVID-19 vaccine.

Tim Wright, Editor, Contract Pharma 01.29.21

Parenterals

Parenteral Drug Delivery Trends

A Q&A with Lubrizol Life Science Health’s CDMO Division President, Rob Lee.

Kristin Brooks, Managing Editor, Contract Pharma 01.27.21

COVID-19 Impact Report

Leaders across the pharmaceutical contract services industry reflect on the impact of COVID-19 in 2020, and what to expect in 2021.

Tim Wright, Editor, Contract Pharma 01.27.21

Almac Expands Global Biologics Testing Services

Investment in mass spectrometry support aims to accelerate biologics development and approval.

Tim Wright, Editor, Contract Pharma 01.27.21

Aphena’s $21M Cookeville Expansion Nears Completion

Bottle packaging capacity has been expanded with the installation of 10 high-speed bottling lines to start.

Kristin Brooks 01.26.21

Breaking News | Collaborations & Alliances

BioMed X, Janssen Enter Oral Drug Delivery Alliance

Aims to discover novel transport mechanisms which could be utilized for oral delivery of therapeutic modalities.

Charles Sternberg, Assistant Editor 01.26.21

Humanigen, Emergent Enter Covid-19 Partnership

Sign contract development and manufacturing agreement for Phase 3 COVID-19 therapeutic candidate lenzilumab.

Tim Wright, Editor, Contract Pharma 01.25.21

Samsung Bioepis Opens New Headquarters

The 52,000-square-foot campus to become the hub of Samsung Bioepis’ drive for accelerated development of next-gen biologic medicines.

Tim Wright, Editor, Contract Pharma 01.25.21

Breaking News | Promotions & Moves

AGC Biologics Appoints Boulder Site GM

David Stewart to oversee the startup, strategic development and operational excellence in large-scale biologics production at the Boulder, CO site.

Kristin Brooks 01.22.21

Biologics Development & Manufacturing

Innovate | Integrate | Customize | Accelerate

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Cognate BioServices Announces Major Expansion

Will increase cell and gene therapy manufacturing capacity, laboratory space, warehousing capabilities and more.

Contract Pharma Staff 01.15.21

Biologics, Proteins, Vaccines | Breaking News | Industry News

Thermo Fisher Buys Novasep's Viral Vector Manufacturing Biz

Pays more than $800 million to expand global capacity and address growing demand for cell and gene therapy.

Contract Pharma Staff 01.15.21

Breaking News | Collaborations & Alliances

Charles River Partners with JADE

Expands its biologics testing capabilities geographically and helps to accommodate demand for biologics therapeutics.

Contract Pharma Staff 01.14.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Cytiva Delivers Modular Biologics Factory to Lonza

Site to become a strategic base in China for Lonza to provide CDMO services throughout Asia Pacific region.

Contract Pharma Staff 01.14.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Fujifilm, CABIM Get $76M Funding for Mfg. and Innovation Center

FUJIFILM Diosynth Biotechnologies will provide GMP contract process development and manufacturing services as part of its role in the new center.

Contract Pharma Staff 01.14.21

APIs | Breaking News | cGMP Manufacture | Fill/Finish | Industry News

LSNE Expands Fill Finish and Lyophilization Ops

New automated fill line at Bedford Campus adds ready-to-use aseptic filling and freeze-dryer capacity.

Contract Pharma Staff 01.14.21

Catalent Acquires Acorda’s INBRIJA Manufacturing Operations

The CDMO pays $80 million for dry powder inhaler spray drying, capsule manufacturing and packaging operations in Boston area.

Contract Pharma Staff 01.13.21

Biologics, Proteins, Vaccines | Breaking News | Clinical Trial Materials | Industry News | Process Development

Capricor, Lonza Enter CAP-1002 Development Agreement

Lonza will perform process development activities for late-clinical and commercial-scale GMP manufacturing of CAP-1002.

Contract Pharma Staff 01.12.21

Baxter, Novavax Ink Sterile Manufacturing Agreement

CMO Baxter will help increase commercial production and promote access to Novavax' Covid-19 vax in UK and European markets.

Contract Pharma Staff 01.11.21

Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News | Information Technology

Leukocare Starts Operations in the US

Opens development laboratories and offices in Boston area.

Contract Pharma Staff 01.11.21

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News | Laboratory Testing

Biohaven Acquires Remaining Stake in Kleo Pharmaceuticals

Enters exclusive license agreement with Yale University for a novel extracellular degrader technology licensed from Spiegel Lab.

Contract Pharma Staff 01.08.21

Aseptic Processing | Breaking News | Collaborations & Alliances | Parenterals

Catalent Divests Blow-Fill-Seal Sterile CDMO Business

SK Capital makes the acquisition; new independent company to be formed.

Contract Pharma Staff 01.07.21

Alcami Expands Oral Solid Capabilities with Investment in Wilmington, NC

...

Structural Characterization of Biologics Using High-Resolution Mass Spectrometry

High-resolution mass spectrometry is a key component in the characterization of novel biologics and biosimilars.

Fujifilm to Invest $40M in New Facility

State-of-the-art viral vector and advanced therapy process development and manufacturing facility will be located in Boston area.

Contract Pharma Staff 01.05.21

Drug Development | Industry News | Regulatory Affairs

The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".

Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups 01.05.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

AGC Biologics Manufactures Orchard Therapeutics' Libmeldy

European Commission approves one-time therapy for early-onset Metachromatic Leukodystrophy, manufactured at AGC's Milan facility.

Contract Pharma Staff 01.04.21

Analytical Services | Biologics, Proteins, Vaccines | Clinical Trial Materials | Laboratory Testing

Samsung Biologics Continues to Leverage Digitalization to Optimize Client Experience

Through digital transformation, Samsung Biologics is innovating how they connect with clients, regulatory bodies and industry professionals.

Breaking News | cGMP Manufacture

Ajinomoto Bio-Pharma and Revance Therapeutics Partner

Sign manufacturing agreement for supply of DaxibotulinumtoxinA for injection.

Contract Pharma Staff 12.22.20

Breaking News | Industry News | Trials & Filings

Moderna Wins FDA Authorization for COVID-19 Vax

The primary efficacy analysis conducted on 196 cases indicated a vaccine efficacy rate of 94.1%.

Contract Pharma Staff 12.21.20

Abenza Promotes Kimball Hall to President

Hall also joins the Company Board.

Contract Pharma Staff 12.18.20

Bio News | Breaking News | Industry News | Promotions & Moves

Samsung Biologics Names John Rim as President and CEO

Prior to being named chief executive, Rim was executive vice president at the Korea-based CDMO for the past three years.

Contract Pharma Staff 12.16.20

Collaboration Creates Bio Hub in Northern UK

CDMO Fujifilm Diosynth Biotechnologies is part of Northern Bio-Accelerator Partnership.

Contract Pharma Staff 12.16.20

Samsung Biologics Adopts Veeva Vault QMS to Unify Quality Management

CDMO is managing quality processes and content for greater visibility and compliance across global manufacturing.

Contract Pharma Staff 12.16.20

Breaking News | Industry News

AstraZeneca to Acquire Alexion in $39B Deal

Expands scientific presence in immunology by adding Alexion's innovative complement-technology platforms and strong pipeline, and top seller Soliris.

Contract Pharma Staff 12.14.20

Breaking News | Industry News

CPI Scales Up Manufacturing of Pyocin S5

A promising treatment for lung infection in cystic fibrosis patients developed by the University of Glasgow.

Contract Pharma Staff 12.14.20

Breaking News | cGMP Manufacture | Fill/Finish | Industry News | Parenterals

Thermo Fisher Scientific Further Expands Global Footprint

Will expand sites in Greenville, NC; Swindon, UK; and Ferentino and Monza, Italy for sterile drug product development and commercial manufacturing.

Contract Pharma Staff 12.10.20

Bio News | Breaking News | Collaborations & Alliances | Industry News

atbtherapeutics, iBio CDMO Enter Manufacturing Agreement

Will work together for the industrialization of the GMP manufacturing process of atbtherapeutics’ atbodies.

Contract Pharma Staff 12.09.20

Sesen Bio Enters Mfg. and Supply Partnership with Qilu Pharma

Technology transfer to Qilu anticipated to be completed in mid-2021.

Contract Pharma Staff 12.09.20

Breaking News | Industry News | R&D

Colorcon Ventures Invests in i20 Therapeutics

Will work together to accelerate i2O’s research and development efforts.

Contract Pharma Staff 12.07.20

Breaking News | Facilities | Industry News | Information Technology

Samsung Biologics Launches Virtual Showroom

Provides key features and real-time construction updates of its recently announced Plant 4.

Contract Pharma Staff 12.07.20

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Keneka Eurogentec Joins Inovio’s Global Mfg. Consortium

Agrees to manufacture Innovio’s Covid-19 vaccine candidate INO-4800.

Contract Pharma Staff 12.03.20

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Tubulis, WuXi Biologics and WuXi STA Form Strategic Pact

Will advance a new generation of antibody-drug conjugates towards clinical evaluation.

Contract Pharma Staff 12.03.20

Breaking News | Industry News

AGC Biologics Expands Copenhagen Facility

Increases its production capacity with a total investment of approximately $194.5 million.

Contract Pharma Staff 12.03.20

BD to Invest $1.2B in Pre-Fillable Syringe Manufacturing Capacity

Will roll-out over the next four years and includes a new manufacturing facility in Europe.

Contract Pharma Staff 12.03.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

iBio to Provide CDMO Services for ATB Therapeutics

iBio will produce ATB’s bioengineered antibody-toxin fusion proteins.

Contract Pharma Staff 12.03.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Cytovance Expands Partnership with Nature Technology Corp.

Now offers NTC’s proprietary HyperGRO manufacturing platform for plasmid DNA CGMP manufacturing.

Contract Pharma Staff 12.03.20

Breaking News | Drug Development | Promotions & Moves

NeuBase Therapeutics Appoints Chief Scientific Officer

Dr. Curt Bradshaw brings decades of experience in successfully delivering genetic medicines to clinics.

Contract Pharma Staff 12.02.20

Bioanalytical Services | Breaking News | cGMP Manufacture | Industry News

KBI Biopharma Expands U.S. Ops

Invests $150 million in commercial biologics manufacturing facility in RTP, NC.

Contract Pharma Staff 12.02.20

Embion, Asahi Group Enter Strategic Collaboration

Plan to develop new products from brewing by-products generated by Asahi Group.

Contract Pharma Staff 12.01.20

CDMO Stelis Continues Expansion

Starts next phase of investment into its biologics manufacturing facility.

Contract Pharma Staff 12.01.20

Recipharm Inks Covid-19 Vax Pact with Moderna

Signs of letter of intent for aseptic fill-finish manufacturing of Moderna’s COVID-19 vaccine candidate (mRNA-1273).

Contract Pharma Staff 12.01.20

Life Science Success Podcast: Matt Hicks

...

Bio News | Breaking News | Facilities | Industry News

Samsung Biologics Breaks Ground on 'Super Plant'

When completed, the CDMO says it will be the world's largest bio-manufacturing facility.

Contract Pharma Staff 11.24.20

Breaking News | Facilities | Industry News

Abenza Upgrades Chemistry GMP Suites

Appoints new leadership at Bristol PA site.

Contract Pharma Staff 11.24.20

Baxter Invests $50M to Expand Sterile Fill/Finish Manufacturing Operations

Construction currently underway; expected to be completed in 2021.

Contract Pharma Staff 11.24.20

Breaking News | Drug Development | Trials & Filings

Regeneron's COVID-19 Antibody Cocktail Gets EUA

Expects to have treatment doses ready for approximately 80,000 patients by the end of November, and 200,000 by the first week of January.

Contract Pharma Staff 11.23.20

Bio News | Breaking News | Collaborations & Alliances | Industry News

Samsung Biologics Partners with Eli Lilly

Accelerates the delivery of Covid-19 antibody treatments.

Contract Pharma Staff 11.20.20

Promotions & Moves

Catalent Appoints Open Innovation, Biologics, Cell and Gene Therapy VP

Behzad Mahdavi brings more than 20 years of experience in developing and implementing growth strategies in the biopharmaceutical industries.

Contract Pharma Staff 11.19.20

Collaborations & Alliances | Drug Development

Cue Biopharma, Merck Extend Biologics Research Alliance

To develop clinical candidate for the treatment of type 1 diabetes and an additional undisclosed autoimmune disease.

Contract Pharma Staff 11.19.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Asahi Kasei Pharma Contracts ProBioGen

Will use ProBioGen’s technologies for the advancement of its biologics pipeline.

Contract Pharma Staff 11.18.20

Bio News | Breaking News | Industry News

Bionova Scientific Secures First Client Commitment

Its new biologics manufacturing facility is still months from completion.

Contract Pharma Staff 11.18.20

Cell & Gene Therapy Supply Chain: Early Preparation is Key

Supply chain management for cell and gene therapies requires precise demand planning and forecasting.

Matthew Farabaugh, Chief Financial Officer, The Discovery Labs 11.17.20

A Potential “Marriage”

Initiator companies and generics/CMOs working together.

Emil W. Ciurczak, DoraMaxx Consulting 11.17.20

Injectables Firms Expand Capacity

CDMOs see steriles demand grow.

S. Harachand, Contributing Editor 11.17.20

Scale-up/Technology Transfer

Ensuring Quality During the Transfer and Scale Up of Rx Drugs

Defining the key parameters and considerations for a successful technology transfer.

Tom Chang, President, Bora Pharmaceutical Laboratory Co. Ltd. 11.17.20

Bioassay Development | Biologics, Proteins, Vaccines | Drug Development | Facilities

Opportunities in Synthetic Biology

Les Tillack, CEO of Luina Bio, discusses how ‘synbio’ is driving growth in the biopharma industry.

Contract Pharma Staff

Breaking News | Collaborations & Alliances | CRO News

PathoQuest, Charles River Expand Strategic Pact

Establishes a biologics genomic testing laboratory in Wayne, PA to expand next-generation sequencing capabilities.

Contract Pharma Staff 11.12.20

Breaking News | Industry News | Promotions & Moves

Cytovance Appoints CEO

Bin Zhang has been with Cytovance as a member of the Board of Directors since 2018.

Contract Pharma Staff 11.12.20

Bio News | Breaking News | Facilities | Industry News

Stelis BioSource Continues Facility Investment

Will install two 2,000L single-use bioreactor trains in its mammalian CGMP facility.

Contract Pharma Staff 11.12.20

Bioanalytical Services | cGMP Manufacture | Drug Development | Scale-up/Technology Transfer

CDMOs: Keeping up with Science & Technology

Enhancing the development of increasingly advanced and complex drug candidates is needed to drive growth in the industry.

Kristin Brooks, Contract Pharma 11.12.20

Lyophilization

LSNE Contract Manufacturing – The Recognized Leader in Lyophilization and Sterile Manufacturing

A history of execution. A reputation for excellence.

Breaking News | Cold Chain Management | Fill/Finish | Industry News | Vials

Aphena Adds Cold Chain Storage, Biologics Packaging and Distribution

Expansion includes 14,000 cold chain pallet spaces in new 500K-sq.-ft. facility.

Contract Pharma Staff 11.11.20

AC Immune and WuXi Biologics Expand Strategic Partnership

Plan to accelerate AC Immune’s TDP-43 antibody into clinical development.

Contract Pharma Staff 11.10.20

Gilead Bolsters Biologics Capabilities

Licenses ProteoNic’s 2G UNic Technology Platform for production of biologics.

Contract Pharma Staff 11.10.20

Breaking News | Drug Development | Promotions & Moves

Inozyme Pharma Appoints SVP, Regulatory Affairs

Dr. Kevin B. Johnson brings over 25 years of experience to the role.

Contract Pharma Staff 11.09.20

Fareva Expands Sterile Production Capabilities

Grows footprint with site acquisition in France and Austria.

Contract Pharma Staff 11.06.20

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Drug Development | Industry News

Jubilant Radiopharma, SOFIE Biosciences Ink Strategic Pact

Jubilant will be a strategic partner to SOFIE enabling SOFIE to expand production capacity and advance its theranostic pipeline.

Contract Pharma Staff 11.04.20

Bio News | Breaking News | Collaborations & Alliances | Industry News

TFF Expands Engagement with Experic

Agrees to install a TFF processing line and its associated capabilities at Experic’s cGMP facility in NJ.

Contract Pharma Staff 11.03.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Samsung Biologics Expands in China

Partners with Chinese biotech GeneQuantum Healthcare on ADC development.

Contract Pharma Staff 11.03.20

Bio News | Breaking News | cGMP Manufacture | Industry News

eTheRNA Extends mRNA Production Services

Adds high throughput research grade mRNA to its GMP capabilities.

Contract Pharma Staff 11.03.20

Breaking News | Industry News

Samsung Biologics, Checkpoint Therapeutics Expand Cosibelimab Mfg. Pact

Samsung Biologics will provide additional commercial-scale drug substance manufacturing.

Contract Pharma Staff 11.02.20

Bio News | Breaking News | Drug Development | Facilities | Industry News

Samsung Biologics Expands Global Footprint

Opens new San Francisco CDO R&D Center.

10.30.20

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances

AB2 Bio and WuXi Biologics Enter Collaboration

Set-up and accelerate commercial-scale manufacturing of Tadekinig alfa.

Contract Pharma Staff 10.29.20

DOD Awards Ology Vaccine Manufacturing Contract

CDMO to manufacture and test novel live attenuated tularemia vaccine candidate.

Contract Pharma Staff 10.28.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

MolMed S.p.A Becomes AGC Biologics S.p.A

AGC Biologics now provides end-to-end cell and gene therapy CDMO services.

Contract Pharma Staff 10.28.20

Breaking News | Industry News

Stevanato, Catalent Partner to Expedite Equipment Installation

Stevanato’s high-speed visual inspection machines will support biologic and vaccine programs at Catalent manufacturing sites in U.S. and Italy.

Contract Pharma Staff 10.27.20

3P Biopharmaceuticals and SpyBiotech Enter Vaccine Contract Manufacturing Agreement

Looking towards completing production in 2021.

Contract Pharma Staff 10.26.20

Breaking News | Collaborations & Alliances | Facilities | Industry News

Construction Starts on the Medicines Manufacturing Innovation Center

Will offer next-gen solutions in small molecule and pharmaceutical manufacturing.

Contract Pharma Staff 10.26.20

Breaking News | Facilities | Industry News | QA/QC

Wuxi Griffin Completes Investment in New QC Lab and Storage Facility

Offers fully equipped microbiology and analytical testing lab for bulk and final product testing.

Contract Pharma Staff 10.26.20

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances

ABEC Delivers Process Systems to Ology Bio

Supports production of critical vaccines and therapeutics for COVID-19.

Contract Pharma Staff 10.22.20

Clinical Trials | Drug Development | Preclinical Outsourcing

Accelerating R&D Trends

The pandemic has propelled lingering trends into the forefront and increasingly complex molecules and biologics have drug developers outsourcing more.

Kristin Brooks, Contract Pharma 10.20.20

APIs | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

JSR Life Sciences Expands European Footprint

Will co-locate primary European operations for affiliate companies KBI Biopharma and Selexis SA in Geneva’s ZIPLO campus.

10.20.20

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development

Samsung Biologics, Dinona Partner on Potential COVID-19 Antibody Therapy

Will collaborate for fast-track development of DNP-019, a potential COVID-19 antibody therapy.

10.20.20

APIs

Emphasizing Sustainability in Contract Manufacturing

Ajinomoto Bio-Pharma Services outlines its commitment to protecting the environment.

Contract Pharma Staff

Bio News | Breaking News | Collaborations & Alliances | Industry News

Antegene, WuXi Biologics Enter Oncology R&D Alliance

To collaborate on the development and production of novel drugs, and jointly promote the R&D of innovative oncology therapies in China.

Contract Pharma Staff 10.19.20

Promotions & Moves

Touchlight Appoints CEO

Karen will work to further expand the company's contract manufacturing business, which delivers GMP materials to third parties developing COVID-19 vaccines.

Contract Pharma Staff 10.16.20

Breaking News | Industry News | Promotions & Moves

Vigene Biosciences Appoints COO

Molly McGlaughlin brings 27 years of experience in biologics manufacturing and development.

Contract Pharma Staff 10.15.20

Capsules | Solid Dosage/Creams/Ointments

Capsule Technology Trends

A look at the capsule market with a particular focus on the factors driving increased demand in non-gelatin-based formulations.

Julien Lamps, Product Manager, Lonza 10.14.20

Aseptic Processing | Fill/Finish

A Holistic Cleanroom Concept: Higher Quality and Greater Flexibility

Overcoming today’s aseptic fill-and-finish process challenges.

Ute Schleyer, Project Manager, Site & Plant Development, Vetter 10.14.20

The Pandemic’s Become an Insurmountable Opportunity

Every Cloud has a Silver Lining(?)

Emil W. Ciurczak, Contributing Editor 10.14.20

Analytical Services | Bioanalytical Services | Breaking News | Industry News | Laboratory Testing

PPD to Open Multipurpose Clinical Research Lab in Suzhou

Will offer bioanalytical, biomarker and vaccine services for global and China-based biopharma customers.

10.14.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

KindredBio Expands Manufacturing Agreement with Vaxart

Centaur will manufacture Vaxart’s oral vaccine for COVID-19 and other vaccine candidates.

Contract Pharma Staff 10.13.20

Biologics, Proteins, Vaccines | Breaking News | Industry News

MilliporeSigma Launches VirusExpress Platform

Scalable platform increases dose yields and reduces process development time for cell and gene therapies.

10.13.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Fujifilm Diosynth to Manufacture Lilly COVID-19 Antibody

Commercial manufacturing of the antibody therapy is expected to commence in April 2021.

Contract Pharma Staff 10.13.20

Breaking News | Facilities | Industry News | Injectables | Packaging & Tracking

Sharp Invests $10M in Biologics, Injectables Packaging Equipment

Investment includes the installation and validation of two Dividella NeoTopx packaging systems.

Contract Pharma Staff 10.13.20

Breaking News | Industry News | Inspections

Symbiosis Completes MHRA Regulatory Inspection

Scottish CMO recorded no critical or major observations from the reinspection by the MHRA.

Contract Pharma Staff 10.13.20

cGMP Manufacture | Drug Development | Promotions & Moves

AGC Biologics Appoints New GM of Milan Site

Luca Alberici will initiate integration efforts resulting from the July 2020 acquisition of MolMed.

Contract Pharma Staff 10.12.20

Breaking News | Collaborations & Alliances | Drug Development | R&D

Antengene, WuXi Biologics Ink Innovative Oncology R&D Alliance

Partner for the development and production of novel drugs, and to jointly promote R&D of innovative oncology therapies.

Contract Pharma Staff 10.12.20

Abzena Invests $60M Into cGMP Manufacturing Capacity

New facility in San Diego houses a process development laboratory and two new cGMP manufacturing cleanrooms.

Contract Pharma Staff 10.08.20

Biologics, Proteins, Vaccines | Breaking News

Kindred Bio Expands Agreement with Vaxart

Centaur will manufacture Vaxart’s oral vaccine for COVID-19 and other vaccine candidates.

Contract Pharma Staff 10.07.20

Biologics, Proteins, Vaccines | Breaking News

FDA Issues Guidance on EUA for COVID-19 Vaccines

Provides further information on the EUA process for investigational vaccines.

Contract Pharma Staff 10.07.20

Breaking News | R&D

Samsung Biologics Adopts Solentim Solutions in R&D Center

Solentim’s instruments will be used in conjunction with Samsung Biologics’ proprietary cell line platform.

Contract Pharma Staff 10.07.20

Breaking News | Collaborations & Alliances | Industry News

Irisys Signs Contract with TFF Pharma

Will produce medication to treat lung conditions, including COVID-19.

Contract Pharma Staff 10.06.20

Breaking News | Promotions & Moves

Abenza Appoints SVP and Site Head

Giovanni Escobar brings over 27 years’ experience in the Pharmaceutical industry.

Contract Pharma Staff 10.06.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

iBio Enters into Agreement with Safi Biosolutions

To develop growth factors and cytokines using the FastPharming system.

Contract Pharma Staff 10.06.20

Breaking News | Industry News

Formulated Solutions Receives Three ISO Certifications

Company is also pursuing ISO13485:2016 Medical Devices Quality Management Systems.

Contract Pharma Staff 10.06.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

GT Biopharma and Cytovance Biologics Expand Partnership

Cytovance will be the exclusive GMP manufacture for three of the company's TriKE therapeutic product candidates.

Contract Pharma Staff 10.06.20

Breaking News | Collaborations & Alliances | Drug Development

Diamond Pharma Services Supports GenSight Biologics

Provides EU regulatory, pharmacovigilance, quality and compliance support for LUMEVOQ.

Contract Pharma Staff 10.05.20

Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News

Cobra Biologics to Manufacture Plasmids for COVID-19 Vax Trial

Collaboration will ensure GMP production of material for Phase I clinical trial of Scancell’s DNA vaccine against SARS-CoV-2.

Contract Pharma Staff 10.05.20

Breaking News | Promotions & Moves

3P Expands Management Team

Adds José Luis Bartolomé as operational excellence and continuous improvement director.

Contract Pharma Staff 10.02.20

Breaking News | cGMP Manufacture | Industry News | Parenterals | QA/QC

Lonza Expands QC Testing Portfolio

Launches PyroCell MAT System for in vitro Pyrogen testing to help ensure safety of parenteral pharmaceuticals during development, manufacture and release.

Contract Pharma Staff 10.01.20

Bioanalytical Services | Breaking News | Industry News | Laboratory Testing

Almac Launches Biologics Testing Services

New services include GMP lot release and stability testing to support drug substance and drug product programs for biologics and biosimilars.

Contract Pharma Staff 09.25.20

Catalent Acquires New Biologics Facility

Creates North American clinical manufacturing center of excellence.

Contract Pharma Staff 09.24.20

Bio News | Breaking News | Collaborations & Alliances | Industry News

Samsung Biologics Signs Deal with Kanaph Therapeutics

To develop treatment for retinal diseases.

Contract Pharma Staff 09.24.20

Bio News | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News

Samsung Biologics and AstraZeneca Ink Manufacturing Deal

Partnership for global supply could be worth more than $545 million.

Contract Pharma Staff 09.22.20

Breaking News | cGMP Manufacture | Collaborations & Alliances

PharmAbcine Partners with Samsung Biologics for PMC-403

The antibody is expected to enter a global ophthalmological clinical trial in 2022.

Contract Pharma Staff 09.21.20

Samsung Biologics Inks Service Pact with Panolos Bioscience

Will provide cell line development, process development, and clinical material manufacturing for PB101, an Fc-fusion protein to treat solid tumors.

Contract Pharma Staff 09.17.20

Aseptic Processing | Lyophilization

Planning and Executing a Media Fill: A Guide to Aseptic Process Validation for Lyophilized Products

This webinar from Lubrizol Life Science on Nov 4 will explore key considerations in designing and executing aseptic process simulations for lyophilized products

09.10.20

Cobra Biologics and CombiGene Partner

Sign agreement to secure GMP production of plasmids for production of CG01 gene therapy.

Contract Pharma Staff 09.10.20

Breaking News | Facilities | Industry News | Solid Dosage/Creams/Ointments

Swiss American CDMO Expands in Texas

Adds new 131,760 square-foot industrial facility.

Contract Pharma Staff 09.03.20

Bio News | Bioassay Development | Breaking News | Industry News

Adma Biologics Launches COVID-19 Assay

Detects SARS-CoV-2 neutralizing antibodies in plasma.

Contract Pharma Staff 09.03.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

HJB and Ansun Biopharma Enter Biologics Collaboration

CMC development and manufacturing partnership expecting to submit an IND application in 2021.

Contract Pharma Staff 09.01.20

Mapp Biopharma Partners with CDMO Avid Bioservices

For clinical development of novel human monoclonal antiviral antibody.

Contract Pharma Staff 08.26.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News

CDMO Ology Bioservices Gets $106.3M U.S. Army Contract

To reserve production capacity in support of Operation Warp Speed.

Contract Pharma Staff 08.26.20

Bio News | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News

AGC Biologics Completes PPQ Mfg. Campaign with Provention Bio

For type 1 diabetes product candidate, teplizumab.

Contract Pharma Staff 08.26.20

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Maravai LifeSciences Expands CDMO Capabilities at TriLink

To increase small molecule manufacturing capacity for additional scale-up of CleanCap messenger RNA capping technology for vaccine and therapeutic programs.

Contract Pharma Staff 08.25.20

Bio News | Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News

AGC Biologics Enters CDMO Partnership with Ono Pharmaceuticals

To manufacture biopharmaceuticals at clinical development stage.

Contract Pharma Staff 08.20.20

Breaking News | Industry News

Swiss American CDMO Appears In 2020 Inc. 5000 List

Named one of the fastest-growing private companies in America.

Contract Pharma Staff 08.18.20

Breaking News | Facilities | Industry News | R&D

CDMO Sai Life Sciences Opens New Facility

State-of-the-art research and technology center is located in Hyderabad, India and completes first phase in $150 million investment.

Contract Pharma Staff 08.18.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Beroni Signs Agreement with CDMO Genscript Biotech

To conduct further study to develop nanobody-based medical solution for COVID-19.

Contract Pharma Staff 08.12.20

CMAB Appoints Chief Financial Officer

Maggie Chen brings 20 years’ experience.

Contract Pharma Staff 08.12.20

Bio News | Breaking News | Facilities | Industry News

Samsung Biologics Expands Footprint

Will break ground on its fourth plant this year, adding 256KL of capacity.

Contract Pharma Staff 08.12.20

Biologics, Proteins, Vaccines | cGMP Manufacture | Industry News | Scale-up/Technology Transfer

AGC Biologics, Novavax Expand Coronavirus Vax Pact

Expands supply of Matrix-M adjuvant for Novavax’ coronavirus vaccine, NVX-CoV2373, from its facility in Seattle for U.S. supply.

Contract Pharma Staff 08.11.20

September 2020: Auction of Late Model and Unused Cannabis & CBD Extraction Equipment

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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News

Samsung Biologics Launches S-CHOice

A new cell line technology with speedy cell division.

Contract Pharma Staff 08.06.20

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Sekisui Diagnostics Invests in Biopharma CDMO Capacity

Investing £14.4 million in its biopharma CDMO business aimed at cGMP microbial capacity expansion at its site in Maidstone, Kent.

Contract Pharma Staff 08.04.20

Bio News | Breaking News | Collaborations & Alliances | Industry News

Altimmune and CDMO Vigene Enter COVID-19 Vax Pact

Ink manufacturing agreement for AdCOVID single dose intranasal vaccine candidate.

Contract Pharma Staff 08.03.20

Breaking News | cGMP Manufacture | Drug Development

Forge Biologics Completes Series A Financing

The company is advancing development candidates for the treatment of Krabbe disease.

Contract Pharma Staff 07.31.20

Breaking News | cGMP Manufacture

Sekisui Invests $18.93 Million in Biopharma CDMO Business

Expands cGMP microbial capacity in Maidstone, Kent site.

Contract Pharma Staff 07.31.20

Bio News | Breaking News | Facilities | Industry News

Samsung Biologics Expands Manufacturing Facility in Incheon

Plans to add a flexible filling line and two additional lyophilizer units.

Contract Pharma Staff 07.27.20

Biologics, Proteins, Vaccines | Breaking News | Industry News

GenScript Expands CDMO Capabilities

Launches CDMO segment "GenScript ProBio" dedicated to providing services from discovery to commercialization.

Contract Pharma Staff 07.23.20

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Just - Evotec Biologics Wins COVID-19 DoD Contract

To develop and manufacture monoclonal antibodies (mAbs) for treatment and/or prevention of COVID-19.

Contract Pharma Staff 07.22.20

How One CDMO Used an Innovative Technology to Overcome Viral Vaccine Production Challenges

Join us for a webinar on 8/18 to learn how Ology Biosciences is leveraging innovative technologies and expertise to bring vaccine production to the next level.

07.20.20

Breaking News | Promotions & Moves

Cytovance Biologics Appoints VP of Development

Dr. John Mott brings over 35 years of industry experience.

Contract Pharma Staff 07.15.20

Bio News | Breaking News | Collaborations & Alliances | Industry News

Samsung Biologics and ImmuneOncia Expand Partnership

Sign multi-product development and manufacturing agreement for five candidate molecules.

Contract Pharma Staff 07.15.20

Breaking News | cGMP Manufacture | Industry News

Cobra Biologics Delivers Plasmids for CombiGene's Epilepsy Candidate

Completes delivery of all plasmids required to progress to the next phase of the project.

Contract Pharma Staff 07.13.20

AGC Biologics, Molecular Partners to Develop DARPin Anti-COVID-19 Program

AGC Biologics will manufacture MP0420 at 100 liter and 1,000 liter scales for development and initial global supply.

Contract Pharma Staff 07.09.20

Breaking News | Industry News

ADMA Biologics Opens New Plasma Collection Facility

Aims to open 5 to 10 more collection centers by the end of 2022.

Contract Pharma Staff 07.06.20

Breaking News | Industry News

AGC Biologics Expands Development Capacities for pDNA Services

Expansion at Heidelberg site will help meet the growing demand for plasmid DNA offerings.

Contract Pharma Staff 07.06.20

Tiziana Enters Manufacturing Tie-up with STC Biologics

For GMP manufacturing of an anti-interleukin-6-receptor monoclonal antibody for clinical studies in patients with COVID-19.

Contract Pharma Staff 06.30.20

Bio News | Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News

PharmAbcine, Binex Ink Long-term Contract Manufacturing Deal

CDMO Binex responsible for large-scale manufacturing of clinical investigational material for PharmAbcine for its global Phase 2 trials of olinvacimab.

Contract Pharma Staff 06.30.20

Breaking News | Industry News | Laboratory Testing

Catalent Biologics Certified for PathHunter Assay Services

Eurofins DiscoverX PathHunter assay platform performs highly reproducible potency lot release assays under GLP/GMP conditions.

Contract Pharma Staff 06.29.20

Biologics, Proteins, Vaccines | Breaking News | Drug Development

SwiftScale Manufactures COVID-19 Antibody Candidate

Uses rapid biologics manufacturing technology to accelerate development of treatments.

Contract Pharma Staff 06.09.20

Drug Delivery

Not Your Father’s Oral Thin Film

A look at how oral film drug delivery is evolving.

Rodolphe Obeid, Vice President of Operations, IntelGenx 06.04.20

A Guide to Vaccine Development from Lubrizol Life Science

The current COVID-19 pandemic emphasizes the need for safe and effective vaccines against new pathogens.

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News

WuXi Launches CAR-T Cell Therapy Platform

Will enable biotechnology companies and researchers to accelerate the development, manufacturing and release of cell and gene therapies for patients

Contract Pharma Staff 05.18.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

CMAB Completes Devt. and Mfg. Project for QureBio

Bispecific antibody Q-1802 will enter clinical trials to assess treatment of solid tumors such as gastric cancer

Contract Pharma Staff 05.14.20

Vibalogics to Manufacture Clinical Material for Janssen

CDMO to provide additional clinical trial material for COVID-19 vaccine candidate

Contract Pharma Staff 05.14.20

Breaking News | Collaborations & Alliances | Drug Development | Drug Discovery

FairJourney Biologics Joins Forces with Iontas

Create a global platform for outsourced antibody discovery services.

Contract Pharma Staff 05.13.20

APIs | Breaking News | cGMP Manufacture | Excipients | Industry News

Evonik Commissions Advanced Biomaterials Production Facility

Expands range of CMO services for the scale-up and commercial manufacturing of customer’s own excipients in Birmingham, AL.

Contract Pharma Staff 05.13.20

Breaking News | Industry News | Laboratory Testing

Thermo Fisher Gets Expanded EUA for SARS‑CoV‑2 Test

This third expansion further increases the number of high-throughput PCR instruments that labs can use to run tests.

Contract Pharma Staff 05.13.20

Breaking News | Collaborations & Alliances | Industry News

Sorrento, Mount Sinai to Develop COVI-Shield Antibody Therapy

Targets SARS-CoV-2 infection (COVID-19) with an antibody cocktail

Contract Pharma Staff 05.12.20

Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News

Key Biologics and Astarte Biologics Rebrand

Will now be known as Cellero

Contract Pharma Staff 05.12.20

Bio News | Breaking News | Collaborations & Alliances | Industry News

Sarepta and Dyno Therapeutics Will Develop Next-Gen Gene Therapy Vectors

Dyno’s proprietary CapsidMap platform opens up new ways to identify novel capsids

Contract Pharma Staff 05.12.20

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

HJB, Mabspace Ink Development and Manufacturing Agreement

Program aims to bring more efficacious treatment options to cancer patients

Contract Pharma Staff 05.12.20

Biopharmaceutical Process Characterization

On June 11, Samsung will demonstrate process understanding needed to develop a robust & scalable mfg process to support successful GMP manufacture of biologics

05.12.20

Breaking News | Clinical Trials | Industry News

Tufts CSDD Releases New Study

Establishes demographic benchmarks for pivotal clinical trials, showing areas of under-representation

Contract Pharma Staff 05.12.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Themis Collaborates with ABL Europe

ABL will manufacture Themis’ SARS-CoV-2 vaccine candidate in France

Contract Pharma Staff 05.12.20

Bio News | Breaking News | Collaborations & Alliances | Industry News

Junshi, Lilly to Develop Antibody Therapies for COVID-19

Multiple neutralizing antibodies have been engineered, with the lead asset poised to enter clinical testing in the second quarter

Contract Pharma Staff 05.12.20

Viral aggregation in downstream processing of lentiviral vectors

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Breaking News | Collaborations & Alliances | Industry News

Sterling Begins HCQ Production in UK

Partners with Accord Healthcare for the manufacture of potential COVID-19 treatment

Contract Pharma Staff 05.11.20

Breaking News | Industry News | Promotions & Moves

Alcami Makes Senior Leadership Appointments

Sally Langa to lead biz dev efforts; Kimberly McClintock returns to head-up marketing

Contract Pharma Staff 05.08.20

Biologics, Proteins, Vaccines | Breaking News | Drug Development

ARTES Biotech to Develop VLP SARS-CoV-2 Vax Candidates

Virus-like particles mimic the conformation of authentic native viruses without being infectious.

Contract Pharma Staff 04.27.20

Breaking News | Drug Development | Industry News

AGC Biologics, AdaptVac Partner to Develop COVID-19 Vaccine

Will leverage AdaptVac's Virus-Like Particle (VLP) technology that could provide a solution to protect against new SARS-CoV-2 infections.

Contract Pharma Staff 04.27.20

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Trials & Filings

Regeneron, Sanofi Release Preliminary Phase II Kevzara Results in COVID-19

Kevzara rapidly lowered C-reactive protein (CRP), a key marker of inflammation, meeting the primary endpoint.

Contract Pharma Staff 04.27.20

Vetter’s high performance is again recognized at the 2020 CMO Leadership Awards

A win in all six core categories reaffirms Vetter as a trusted solution provider

Quality-by-Design Approach to Manufacturing Cell and Gene Therapies

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A Pharmaceutical Smörgåsbord

This last issue of the year covers a wide range of pharma topics.

Tim Wright, Editor 11.20.19

Biologics, Proteins, Vaccines | Biosimilars

Biopharma Over 20 Years

A look at the key trends that have impacted the biopharma industry over the years.

K. John Morrow, Jr. and Eric S. Langer, BioPlan Associates 11.20.19

cGMP Manufacture | Drug Development

Contract Pharma’s 20th Anniversary Series: Catalent

Elliott Berger of Catalent shares his insights on the past 20 years and what we can anticipate for the future of the industry and outsourcing

Kristin Brooks, Contract Pharma 11.08.19

CPhI Worldwide Celebrates 30 Years

Event overview and highlights from the upcoming CPhI/ICSE exhibition taking place in Frankfurt from Nov. 5-7.

10.29.19

Breaking News | Collaborations & Alliances | Industry News | Solid Dosage/Creams/Ointments

Foamix Enters Contract Manufacturing Agreement

Signs manufacturing and supply deal with ASM for AMZEEQ and FMX103.

10.23.19

Contract Pharma’s 20th Anniversary Retrospective

A look back a the pharma/biopharma industry and the future of outsourcing.

Kristin Brooks, Managing Editor, Contract Pharma 10.15.19

Bio News | Breaking News | Industry News | Promotions & Moves

Avid Bioservices Names Richard Richieri as COO

Senior executive with more than 25 years of biopharmaceutical industry manufacturing operations experience.

10.15.19

Bio News | Breaking News | Collaborations & Alliances | Industry News

Rentschler Expands Collaboration with Summit

New contracts secured with Japanese pharmaceutical companies

10.04.19

Breaking News | Facilities | Industry News

Delpharm Sets Sights on Major Expansion

Enters negotiations with Famar for the acquisition of five manufacturing sites in France and abroad.

10.04.19

Breaking News | Fill/Finish | Industry News

Alliance Contract Pharma Adds $2M Liquid Capsule Filling Line

New line has the capability of filling, banding and check weighing 80,000 to 120,000 capsules per hour

09.24.19

Contracting And Outsourcing Exhibitor List

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09.17.19

Changing the Face of CDMOs

Looking for tomorrow’s biopharma leaders today.

Le Ly and Peter Gallagher, Egon Zehnder 09.16.19

Simplifying Recombinant Protein Production: Breaking Down the Corynex Protein Expression System

The rise of biologics is having a dramatic impact on how physicians treat many serious and chronic illnesses.

Critical Factors of Fill Finish Manufacturing For Biologics

The bulk drug substance, formulation, and sterile filtering and filling of the final drug product all require special handling procedures.

Bio News | cGMP Manufacture | Fill/Finish | Industry News

iBio Launches Sterile Fill-Finish Services

Initial capacity supports 100 – 2,500 vials runs, with plans to expand to 15,000

06.03.19

Bio News | Breaking News | Industry News | Promotions & Moves

Avid Names Richard Hancock Interim President & CEO

Industry veteran with over 30 years of operational and executive experience succeeds Roger Lias

05.20.19

Bio News | Breaking News | Facilities | Industry News | Process Development

Sekisui Invests $1.9M in Microbial Biopharma CDMO Business

New BioProcess Innovation Center in UK will be operational by the end of 2019

05.16.19

Breaking News | Drug Discovery | Facilities | Industry News | R&D

Takeda Opens New Global Research Center in San Diego

New facility focuses on specialized drug discovery technologies and discovery research across gastrointestinal and neuroscience therapeutic areas

05.06.19

Bio News | Biologics, Proteins, Vaccines | cGMP Manufacture | Clinical Trial Materials | Industry News

Samsung BioLogics, GI Innovation Ink Second Contract

Samsung BioLogics will provide contract services from the development of cell lines to the production of Phase I drug substances for GI

05.03.19

cGMP Manufacture | Clinical Trial Materials | Drug Development | Industry News

Kite Pharma Expands Mfg. Facility in MD

The facility will significantly expand Kite’s ability to manufacture a variety of CAR-T therapies for both clinical and commercial use

04.26.19

Collaborations & Alliances | Drug Development

WuXi Biologics, I-Mab Biopharma Ink Long-term Strategic Pact

WuXi to provide CMC development and commercial manufacturing

04.16.19

The Unfolding Pharma Product Mix

Should you be diversifying your product portfolio to include production of small molecules and biologics?

Ben Locwin, Contributing Writer 04.05.19

Solid Dosage/Creams/Ointments

Solid Dose Processing & Packaging Trends

Mikart’s senior vice president of business development, John M. Phillips, talks trends with Contract Pharma

Tim Wright, Editor, Contract Pharma 04.05.19

cGMP Manufacture

Next-Gen Bioprocessing Manufacturing

Leveraging advances in bioprocessing technology and overcoming the challenges through outsourcing

Krisitn Brooks, Contract Pharma 04.05.19

Breaking News | Promotions & Moves

Sharp Packaging Names President of US Ops

Kevin Orfan joins Sharp from Pfizer Centreone

04.03.19

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Lonza, Chr. Hansen Set Up Microbiome JV

Headquarters and pharma-grade drug production facility to be established in Switzerland

04.03.19

CPhI North America Event Info

Mix with the world of pharma products, people & solutions!

04.01.19

Breaking News | Promotions & Moves

Paragon Bioservices Appoints New CTSO

Bolsters leadership ranks to support late-stage clinical and commercial biopharma manufacturing

03.22.19

Support Services

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Ophthalmic & Otic

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Nutraceutical Brands Find Relief in Outsourcing Manufacturing

More companies are working with contract manufacturers to manage resources and focus on business development.

Sean Moloughney, Editor, Nutraceuticals World 03.06.19

Breaking News | Facilities | Industry News | Lyophilization

Sagent Acquires Raleigh Mfg. Site

Former Xellia facility used mostly for producing lyophilized injectable products

03.01.19

Breaking News | Reader Showcase

Shimadzu Releases New Gradient System Protein Sequencers

Designed to provide higher sensitivity and more reliable analysis of N-terminal amino acid sequences through automated Edman degradation

02.27.19

Polyphor Awarded $5.6M Grant from CARB-X

To support the development of a novel OMPTA candidate to treat the deadliest and most resistant Gram-negative bacterial pathogens

02.05.19

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News

Olon SpA Acquires Italian CDMO

Buys fellow Italian CDMO Capua Bioservices to expand footprint in field of microbial fermentation

01.28.19

Facilities | Lyophilization

Rising Demand for Lyophilized Products

Jubilant installs new oven to increase manufacturing capacity and keep up with biopharma’s growing need for lyophilization services

Tim Wright, Contract Pharma 01.25.19

Breaking News | Industry News | Promotions & Moves

Jubilant Appoints Director of Business Development

Mark Sassler charged with developing new biz strategies for company ops in Montreal and Spokane areas

12.26.18

APIs | Excipients

Pharmaceutical Fine Chemicals Trends

Moving toward a new order in the pharmaceutical fine chemical / CD&M industry?

Dr. Enrico T. Polastro, Vice President, Arthur D. Little Benelux SA/NV 11.13.18

R&D

Strategic Discovery

CROs top offerings with biology skills.

S. Harachand , Contributing Editor 10.10.18

Bio News | cGMP Manufacture | Collaborations & Alliances | Industry News

HCATS & GSK Sign Clinical Mfg. Agreement

HCATS will manufacture GSK’s SPEAR T-cell receptor therapy targeting NY-ESO-1 for the US, Canadian and European trials

10.02.18

HPAPI Outsourcing Likely to Gain Traction

A number of highly potent drugs will soon fall into the generic domain

S. Harachand, Contributing Editor 09.11.18

Bio News | Collaborations & Alliances | Industry News

WDSrx Acquires Florida Pharmaceutical Products

WDSrx president Adam Runsdorf named Larry Lapila, a 35 year industry veteran, as president of the acquired company

08.15.18

Baxter's BioPharma Solutions Business Recognized with ViE Award for Fifth Time

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Biologics, Proteins, Vaccines

Technological Arms Race Could Improve Bio Process Mfg. Efficiency

Experts warn bio industry needs to do more to create a sustainable pipeline of talent

06.29.18

Information Technology

Putting Data Integrity in Quality Agreements

With growing regulatory scrutiny, sponsors are focusing more on data integrity in supplier quality agreements.

Robert Marohn, ClinLogic, LLC 06.12.18

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

HCATS and Invetech Enter Cell Therapy Mfg. Collaboration

New partnership for automated cell therapy manufacturing platform

06.05.18

Bio News | cGMP Manufacture | Drug Development | Facilities | Industry News

AB BioTechnologies Details Expansion

Dr. Jeff Schwegman details the features of AB's expansion; a new, 23,000 sq. ft. facility

Biologics, Proteins, Vaccines | Biosimilars

Contract BioManufacturing in China: Creating a New Segment

An up-close look at China’s growing market for CMO services.

Vicky Qing Xia and Leo Cai Yang, BioPlan Associates 04.10.18

Hovione Expands Capacity

Plans for future expansion at its sites in Portugal, Ireland and New Jersey

03.19.18

SanBio Signs Contract Mfg. Agreement with Hitachi Chemical

Hitachi will manufacture of regenerative medicine product SB623

03.13.18

cGMP Manufacture

Automation in Pharmaceutical Manufacturing

Technological advancements open the door to fundamental performance improvements in pharmaceutical manufacturing.

Trevor Marshall, Director of Enterprise System Integration, Zenith Technologies 03.09.18

What to Look for in a Contract Manufacturer

Here are some essential considerations when qualifying a manufacturing partner.

Scott Jenkins , COO, Biovation Labs 03.09.18

Pharma Year 2017 in Review

CDMOs grow faster than the Pharma market.

Christoph Bieri, Managing Partner, Kurmann Partners 03.09.18

Promotions & Moves

Zealand Pharma Adds SVP Ops Role

Mr. Møller brings extensive experience in the international pharmaceutical industry

01.19.18

Breaking News | Industry News | Packaging & Tracking | Serialization

Normon Laboratories Selects TraceLink

Partners with serialization solutions provider to comply with EU FMD serialization regs

11.01.17

APIs | Drug Development

Frankfurt Hosts CPhI Worldwide 2017

ICSE expo features 300 pharmaceutical outsourcing service providers, business development forum, networking, and sessions

10.13.17

Aseptic Processing | Injectables

Sterile Manufacturing: Future Trends and Challenges

By the middle of this century, biopharmaceuticals are set to overtake all other pharma sales

Igor Gorsky, Concordia Valsource 10.11.17

APIs | Breaking News | cGMP Manufacture | Facilities | Industry News

Melinta, ScinoPharm Enter API Mfg. Pact

ScinoPharm to provide contract manufacturing for Melinta ’s newly-approved skin infections drug, Baxdela

08.03.17

Promotions & Moves

Paragon Bioservices Appoints Quality VP

Wild is a Quality Executive/Leader with 30 years of experience

07.21.17

CordenPharma & GE Healthcare in Drug Development Pact

Enter collaboration to meet customer need for a simplified, faster development process

06.30.17

cGMP Manufacture | Cytotoxics and High Potency Manufacturing | Industry News | Solid Dosage/Creams/Ointments

Pfizer CentreOne Expands Service Portfolio

Adds contract manufacturing of highly potent solid oral dose at Ireland facility

03.16.17

Solid Dosage/Semi-solids

Oral Solid Dosage Outsourcing: Trends & Challenges

Despite the increasing number of biologics, oral solids remain the dominant dosage form in the pharmaceutical market.

Tim Wright, Editor, Contract Pharma 03.07.17

Capsules | cGMP Manufacture | Solid Dosage/Semi-solids

Contract Manufacturing in the Supplement Industry

With consumer health products in demand, manufacturing specialists offer considerable value.

Sean Moloughney, Editor, Nutraceuticals World 03.07.17

FDA Issues Final Guidance on Quality Agreements

Says the difference between the draft from May ’13 and the final guidance focuses on areas that needed to be clarified

Tim Wright, Editor 01.26.17

Aseptic Processing | Fill/Finish | Parenterals

Aseptic Fill-Finish Trends

Catalent’s Carole Delauney discusses aseptic fill-finish market trends, challenges and growth opportunities.

Tim Wright, Editor, Contract Pharma 01.05.17

Breaking News | Clinical Trial Materials | Facilities | Industry News | Promotions & Moves

Allen Chao to Lead Purdue-based CMO

The Purdue alumnus co-founded Watson Pharmaceuticals

12.14.16

Emergent BioSolutions Reports Third Quarter and Nine Months 2016 Financial Results

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Regulatory Affairs

The Search & Rescue Mission for Data Integrity

Cloud technology is essential for success

Mike Jovanis, Vice President of Vault QualityDocs, Veeva Systems 10.11.16

Breaking News | Industry News

Custom Pharma Services Adds New Location

Expands manufacturing and development operations

09.30.16

cGMP Manufacture | Cytotoxics and High Potency Manufacturing | Drug Development | Industry News

Custom Pharma Services Expands Development /Mfg. Ops

New location adds capacity for clinical and product development of highly potent molecules and commercial manufacturing

09.20.16

Regulatory Affairs

Patent Law and Contract Manufacturing

Analyzing the impact of The Medicines Co. vs. Hospira Inc. decision

Beverly W. Lubit, Member of the Firm, Chiesa Shahinian & Giantomasi 09.08.16

Breaking News | Promotions & Moves

PCI Names Ops Director at Tredegar Site

Most recently served as site leader at Pfizer’s biotech organization

08.15.16

Breaking News | CRO News | Facilities | Industry News | Solid Dosage/Creams/Ointments

Sun Pharma Divests Two U.S. Manufacturing Sites to New CDMO

CRO Frontage Labs creates Frontida Biopharm to provide contract manufacturing and co-development services

06.10.16

APIs | Breaking News | Industry News

Olon SpA Acquires Infa Group

Deal doubles Olon's generics portfolio and strengthens its services to CDMO customers

06.01.16

Industry News | Solid Dosage/Creams/Ointments

Renaissance to Divest Topical Biz to Mylan

Will continue to operate sterile-focused specialty pharmaceutical business in NJ

05.16.16

Analytical Services | cGMP Manufacture | GMPs/GCPs | Industry News | Inspections

WuXi AppTec’s Shanghai Facilities Pass EMA Inspection

Completes third successful EMA inspection for GMP compliance

05.12.16

Promotions & Moves

CPC Appoints BD Director

Sharp to focus on acquiring contract manufacturing, packaging and development opportunities in the Rx space

05.05.16

APIs | Biosimilars | Injectables

Newsmakers: Peter Stevenson

Pfizer’s VP, contract mfg., talks about integrating Hospira One 2 One

Tim Wright, Editor 03.09.16

Chemistry | Process Development | QA/QC | Supply Chain | Validation

Contract Manufacturing: Setting Standards in the Supplement Industry

Ensuring nutraceuticals are produced safely and according to strict quality requirements is paramount in the current climate of regulatory scrutiny.

Sean Moloughney, Nutraceuticals World 03.09.16

Piramal Expands in Kentucky

Adding 40 new jobs after expansion of Coldstream

02.02.16

cGMP Manufacture | Industry News

Sterile University to Train cGMP Drug Mfg. in China

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01.20.16

cGMP Manufacture | Fill/Finish | Promotions & Moves

Recipharm Appoints Kaysersberg GM

Buelens brings pharmaceutical and contract manufacturing experience

01.08.16

cGMP Manufacture | Industry News

Eisai Divests Contract Manufacturing Biz

Alfresa strengthens manufacturing ops with acquisition of Sannova

12.21.15

Baxter Completes Capacity Expansion at Halle, Germany Facility

Supports BioPharma Solutions’ Oncology Contract Manufacturing Services

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Drug Development | Industry News

Dose CMO Industry Growth Not Sustainable

PharmSource report forecasts slowing growth rate as headwinds increase

09.09.15

Novasep to Build Integrated ADC Facility

Invests €10M to reinforce its bioconjugation services

06.25.15

Breaking News | Industry News

Hi-Tech Acquires APN

Strengthens global OTC portfolio

04.13.15

Analytical Services | Process Development | Supply Chain

Changing Prices in the Bio CMO Market

A dynamic market for biopharmaceutical contract manufacturing services is seeing prices rise and fall

William Downey , President, HighTech Business Decisions 03.06.15

Enteris BioPharma Launches Contract Manufacturing Ops

Will offer production of API using microbial expression systems

02.27.15

Aesica Secures FDA Approvals at German Sites

Allows for expanded manufacturing and packaging services for U.S. market

02.02.15

Siegfried Acquires Hameln Pharma

Expands sterile filling segment

12.04.14

UNIGEN Implements Werum's PAS-X MES

Gifu site is among largest plants for production of flu vaccines and biopharmaceutical products

08.13.14

Breaking News | Promotions & Moves

AAIPharma Services and CML Appoints CEO

Lonza veteran brings extensive experience

07.08.14

Kemwell Completes Joint cGMP Audit

Gains certification by Belgium and EU authorities

07.08.14

2014 - Fifteenth Annual Salary and Job Satisfaction Survey

Hiring is up, recruiters say, and soft skills are in short supply. Survey respondents say they’re happy now, but will likely change employers within five years.

Agnes Shanley, Editor 06.05.14

Breaking News | Fill/Finish | Financial Reports