Login
Join
FOLLOW:
Subscribe Free
Magazine
eNewsletter
Checkout
Menu
Magazine
News
Manufacturing
Packaging
Development
Compliance
Top 20
Directory
Solution Center
Events
More
Magazine
News
Manufacturing
Packaging
Development
Compliance
Top 20
Directory
Solution Center
Events
Current / Back Issue
Features
Editorial
Columns
Digital Edition
eNewsletter Archive
Our Team
Editorial Guidelines
Subscribe Now
Advertise Now
Top Features
Working in Tandem: Effective Security for Weight-loss Drug Packaging
Navigating Global CDMO Trends
Anti-Counterfeiting Technology
Making the Most of Real-World Data in Clinical Trials
Inflation Reduction Act and the Impact on Biosimilars
Breaking News
Online Exclusives
Industry News
Collaborations & Alliances
Promotions & Moves
Trials & Filings
Financial Reports
Bio News & Views
Custom Sourcing News
Packaging & Tracking
CRO News
Live From Shows
Top News
Lilly Acquires Manufacturing Facility from Nexus Pharmaceuticals
Kühne Holding AG Agrees to Acquire Aenova Group
BigHat Biosciences Partners with Janssen Biotech to Guide Antibody Discovery & Design
Moderna and OpenAI Join Forces to Transform Healthcare with AI
CureVac Names New Chief Business Officer
APIs
Aseptic Processing
Cleaning Validation
Clinical Trial Materials
Cytotoxics and High Potency Manufacturing
Equipment
Excipients
Extractables and Leachables
Facilities
Fill/Finish
Lyophilization
Parenterals
Process Development
Process Validation
Risk Management
Scale-up/ Technology Transfer
Solid Dosage/ Creams/ Ointments
Lilly Acquires Manufacturing Facility from Nexus Pharmaceuticals
Hanmi, Merck Enter Clinical Collaboration & Supply Agreement
Particle Dynamics Names New Chief Financial Officer
Vertex Obtains Exclusive License to TreeFrog’s C-Stem Technology
BMS & Cellares Announce Worldwide Capacity Reservation & Supply Agreement
Capsules
Cold Chain Management
Injectables
Logistics
Serialization
Solid Dosage / Semi-solids
Supply Chain
Vials
Tower Cold Chain Introduces KTEvolution 12 Containers
Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model
[WEBINAR] Headspace Gas Ingress Methods - The Golden Tool for Container Closure Integrity Testing
[WEBINAR] Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model
Headspace Gas Ingress Methods - The Golden Tool for Container Closure Integrity Testing
Analytical Services
Bioanalytical Services
Bioassay Developement
Biologics, Proteins, Vaccines
Biosimilars
Chemistry
Clinical Trials
Drug Delivery
Drug Development
Drug Discovery
Formulation Development
Information Technology
Laboratory Testing
Methods Development
Microbiology
Preclinical Outsourcing
R&D
Toxicology
Kühne Holding AG Agrees to Acquire Aenova Group
BigHat Biosciences Partners with Janssen Biotech to Guide Antibody Discovery & Design
Tetra Pharm Technologies & Glysious Partner to Develop Transdermal Combination Drugs
Sanofi’s Rilzabrutinib Meets Primary Endpoint in ITP
Tharimmune Announces Option for Novel HER2/HER3 Cancer Therapies
Filtration & Purification
GMPs/GCPs
Inspections
QA/QC
Regulatory Affairs
Validation
Cellares Launches Cell Q Automated cGMP QC Workcell for Cell Therapies
TATAA Biocenter Awarded GLP Accreditation
Anti-Counterfeiting Technology
Do You Know Your Product's Impurity Profile?
Inflation Reduction Act and the Impact on Biosimilars
Companies
Categories
Corporate Capabilities
Add New Company
Contract Service Directory Companies
Lannett CDMO
INCOG BioPharma Services
LOTTE BIOLOGICS
Solvias USA, LLC
Abzena
Companies
News Releases
Posters
Brochures
Services
Videos
Case Study
White Papers
Jobs
Contract Service Directory Companies
Lannett CDMO
INCOG BioPharma Services
LOTTE BIOLOGICS
Solvias USA, LLC
Abzena
Webinars
Live From Shows
Magazine
Current / Back Issue
Features
Editorial
Columns
Editorial Guidelines
Subscribe Now
Advertise Now
Enewsletter Archive
Digital Edition
Directory
Companies
Categories
Corporate Capabilities
Add Your Company
Manufacturing
APIs
Aseptic Processing
Cleaning Validation
Clinical Trial Materials
Cytotoxics and High Potency Manufacturing
Equipment
Excipients
Extractables and Leachables
Facilities
Fill/Finish
Lyophilization
Parenterals
Process Development
Process Validation
Risk Management
Scale-up/ Technology Transfer
Solid Dosage/ Creams/ Ointments
cGMP Manufacture
Packaging
Capsules
Cold Chain Management
Injectables
Logistics
Serialization
Solid Dosage / Semi-solids
Supply Chain
Vials
Development
Analytical Services
Bioanalytical Services
Bioassay Developement
Biologics, Proteins, Vaccines
Biosimilars
Chemistry
Clinical Trials
Drug Delivery
Drug Development
Drug Discovery
Formulation Development
Information Technology
Laboratory Testing
Methods Development
Microbiology
Preclinical Outsourcing
R&D
Toxicology
Compliance
Filtration & Purification
GMPs/GCPs
Inspections
QA/QC
Regulatory Affairs
Validation
Top 20 Pharma & BioPharma
Contract Pharma Direct
Breaking News
Online Exclusives
Slideshows
Experts Opinions
Surveys
Outsourcing Survey
Salary Survey
Glossary
Videos
White Papers
Podcasts
Infographics
Microsites
Companies
News Releases
Posters
Brochures
Services
Videos
Case Study
White Papers
Contract Pharma Conference
Contract Pharma Conference
Speakers
Exhibitors
Conference Sessions
eBook
Webinars
Events
Industry Events
Live from Show Events
Webinars
Classifieds / Job Bank
Classifieds
Job Bank
About Us
About Us
Contact Us
Advertise With Us
Privacy Policy
Terms of Use
Search Results for '
GMP
'
Search For:
Refine by Dates:
From:
To:
Past 7 Days
|
Past 30 Days
Refine By Content:
All
Advanced Degrees
Ask The Board
Ask The Experts
Back Page
Bio News & Views
Blog
Breaking News
Business Corner
Buyers Guide Companies
Case Studies
Classifieds
Columns
Company Blog
Conference Sessions
Content Microsite
Ebook
Editorial
Executive Perspective
Expert's Opinion
FDA Watch
Features
Financial Analysis
Getting Results
Glossary
I Mak
India Report
Industry Events
Infographics
Jobs
Literature / Brochures
Live From Shows
Lowe Down
Managing Your Career
News Releases
Online Exclusives
Outsourcing Survey
Pharma Beat
Podcasts
Posters
Preclinical Outsourcing
Product Releases
Salary Survey
Services
Slideshows
Sponsored Content
Top 25 Pharma & BioPharma
Top Companies Report
Trials & Filings
Videos
Webinars
White Papers / Tech Papers
Breaking News
|
cGMP Manufacture
|
Drug Delivery
|
Drug Development
|
Industry News
Transpire Bio Opens Research, Manufacturing HQ in Florida
Will leverage inhaled drug delivery to develop innovative treatments and will include finished product manufacturing for development purposes.
11.01.23
Biologics, Proteins, Vaccines
|
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Industry News
ViroCell, Great Ormond Street Hospital Partner to Unlock Clinical Trial Backlog
MHRA license will enable global reach of ViroCell’s viral vectors for cell and gene therapy clinical trials.
11.01.23
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Facilities
|
Industry News
Aragen Building $30M Biomanufacturing Site in India
Spanning nearly 160,000 square meters, it includes process development labs and multiple GMP manufacturing suites with supporting functions.
10.30.23
cGMP Manufacture
|
Drug Development
Contracting & Outsourcing 2023: Q&A with CorePharma's CEO Arpit Patel
Provides insight on industry and outsourcing trends, successful partnerships, and expansion projects.
Videos
cGMP Manufacture
|
GMPs/GCPs
|
Inspections
Get Ready for a New Approach to cGMP Inspections
ANDAs, Biosimilars, BLA, FDA, Generics, NDA Regulatory Affairs
Bob Kelly, Principal Consultant, Lachman Consultant Services, Inc.
10.27.23
Biologics, Proteins, Vaccines
|
Breaking News
|
cGMP Manufacture
|
Clinical Trials
|
Collaborations & Alliances
|
Drug Development
|
Drug Discovery
|
Fill/Finish
|
Industry News
Chime Biologics, Hope Medicine Partner on Antibody Drug HMI-115
Hope Medicine will leverage Chime Biologics' extensive experience in 2000L cGMP manufacturing.
10.27.23
Breaking News
|
Drug Development
|
Drug Discovery
|
Facilities
|
Industry News
|
Inspections
Dipharma Receives 2nd GMP Certification from Brazilian ANVISA
The Caronno Pertusella site is the second Dipharma facility to receive ANVISA certification.
10.26.23
Breaking News
|
cGMP Manufacture
|
Clinical Trials
|
Drug Development
|
Drug Discovery
|
Facilities
|
Industry News
CEL-SCI Readies Multikine Facility for Commercial Scale Production
Preparation for biologics license application for regulatory approval submissions.
10.25.23
Breaking News
|
cGMP Manufacture
|
Clinical Trials
|
Collaborations & Alliances
|
Drug Development
|
Drug Discovery
|
Industry News
Alcami Supports Phase II/III Trial Supply Nectero EAST System
Clinical results showed that a single, localized PGG administration to patients with small- to mid-sized infrarenal AAAs was safe.
10.24.23
Breaking News
|
cGMP Manufacture
|
Collaborations & Alliances
|
Drug Development
|
Drug Discovery
|
Industry News
CMIC CMO, Rutgers Partner to Advance Pharmaceutical Manufacturing Excellence
Aims to integrate state-of-the-art infrastructure for rapid product and continuous process development in both non-GMP and GMP environments.
10.24.23
Breaking News
|
cGMP Manufacture
|
Collaborations & Alliances
|
Drug Development
|
Drug Discovery
|
Industry News
OBiO, Refreshgene Partner on Commercialization of Gene Therapy
OBiO will leverage its capabilities of process development, large-scale cGMP commercial production and global business development.
10.24.23
Breaking News
|
cGMP Manufacture
|
Collaborations & Alliances
|
Drug Development
|
Drug Discovery
|
Industry News
KKR, Flerie Form Specialized Pharma Services Platform with Investment in Coriolis Pharma
To extend Coriolis’ position in formulation development and analytical services for innovative high-value biologics, cell and gene therapy products.
10.24.23
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Facilities
|
Industry News
Sanner Group Opens New Global Headquarters
Facility will house a flexible injection molding and assembly hall that can meet packaging and device CDMO requirements.
10.23.23
Breaking News
|
cGMP Manufacture
|
Excipients
|
Industry News
Evonik Launches GMP-Quality Plant-Based Squalene
PhytoSquene now available for clinical and commercial use.
10.23.23
Breaking News
|
cGMP Manufacture
|
Collaborations & Alliances
|
Drug Development
Andelyn, Purespring Partner to Advance Gene Therapies for Kidney Diseases
Will leverage Andelyn’s suspension platform to manufacture its preclinical and clinical gene therapy products.
10.20.23
APIs
|
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Drug Discovery
|
Industry News
Almac Announces £80M Expansion at Global Headquarters
Includes an extension to current scales of production for products involving potent and highly potent APIs.
10.19.23
Breaking News
|
cGMP Manufacture
|
Facilities
|
Fill/Finish
|
Industry News
Sever Pharma Expands Aseptic Filling Line for High Potent Injectables
Enhances manufacturing capacity and allows for integration with assembly solutions for auto-injectors.
10.19.23
Biologics, Proteins, Vaccines
|
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Industry News
eXmoor Opens GMP Facility in the UK
Cell and gene therapy Center will help developers take advanced therapies from concept to clinic.
10.18.23
Biologics, Proteins, Vaccines
|
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Drug Discovery
|
Industry News
Integrated DNA Technologies Opens Manufacturing Facility
41,000-sq.-ft.-site will produce cGMP cell and gene therapy reagents, including single guide RNAs and donor oligos for homology-directed repair.
10.18.23
Biologics, Proteins, Vaccines
|
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Industry News
Avid Bioservices Completes cGMP Manufacturing Suites at CGT Facility
The 53,000 sq.-ft. development and manufacturing facility will support early-stage development through commercial manufacturing.
10.17.23
APIs
|
Breaking News
|
cGMP Manufacture
|
Industry News
C2 PHARMA Expands API Portfolio with Global Regulatory Access
Signs an agreement with an additional CMO partner, SMS Lifesciences, to strengthen its manufacturing network.
10.17.23
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Industry News
Nucleus RadioPharma Secures Funding for New Manufacturing Facilities
Will establish multiple new manufacturing facilities around the country, including Rochester, MN, near Mayo Clinic for radiopharmaceuticals.
10.17.23
Biologics, Proteins, Vaccines
|
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Industry News
Vaxcyte, Lonza Partner on Manufacture of Pneumococcal Vax
Aims to establish global commercial manufacturing capacity for Vaxcyte's PCV candidates, VAX-24, and VAX-31.
10.16.23
Breaking News
|
cGMP Manufacture
|
Industry News
|
Information Technology
Leucine Nets $7M to Level Up Pharma Manufacturing Compliance
Move designed to scale the company's AI-driven compliance cloud platform globally.
10.16.23
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Promotions & Moves
Quotient Sciences Names Thierry Van Nieuwenhove CEO
Thierry succeeds Mark Egerton who is retiring after 18 as CEO.
10.16.23
Biologics, Proteins, Vaccines
|
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Fill/Finish
|
Industry News
Lonza Unveils New Filling Line for Commercial Supply of ADCs
Expansion of filling capacity will enhances integrated offering for manufacturing ADCs drug substance and drug product.
10.13.23
cGMP Manufacture
|
Facilities
|
Supply Chain
The Ukrainian Pharmaceutical Industry is Alive and Kicking
While the Ukrainian pharmaceutical industry is operational, it will likely live in a state of uncertainty for some time while fighting rages on.
Contract Pharma
10.12.23
cGMP Manufacture
|
Facilities
China: The New Frontier for Western CDMOs?
China’s pharmaceutical sector continues to transition from a low-cost manufacturing hub into a source of innovative technologies and products.
Dr. Michele Jermini & Dr. Enrico Polastro
10.12.23
cGMP Manufacture
|
Cytotoxics and High Potency Manufacturing
The Evolution of HPAPI Manufacturing for CDMOs
The demand for highly potent APIs has been steadily increasing, driven by the development of targeted therapies in oncology and other disease areas.
Adam Kujath, EVP and Site Head, Germantown, Sterling Pharma Solutions
10.12.23
Biologics, Proteins, Vaccines
|
cGMP Manufacture
|
Parenterals
Symbiotic Success: How CDMOs Shaped a Decade of Biomanufacturing
Growth in revenues of biologics outsourcing.
Doug Nissinoff, Senior Research and Strategy Associate, BioPlan Associates, Inc
10.12.23
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Facilities
|
Industry News
Aenova Expands Capacity at Manufacturing Site in Italy
Aims to enhance existing infrastructure in four areas covering both pharmaceutical and cosmetic products.
10.12.23
Biologics, Proteins, Vaccines
|
Breaking News
|
cGMP Manufacture
|
Industry News
AGC Biologics Completes pDNA and mRNA Line Expansion in Heidelberg
Can now offer more plasmid material in high-quality and GMP grades and expand the services it offers for mRNA supply.
10.12.23
Breaking News
|
cGMP Manufacture
|
Industry News
|
Information Technology
ValGenesis, Brevitas Announce Strategic VLMS Partnership
Brevitas will implement and support the ValGenesis product suite, including ValGenesis VLMS, and VLMS Express.
10.12.23
Biologics, Proteins, Vaccines
|
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Industry News
Quantoom Biosciences Gets Gates Foundation Grant to Support mRNA Vax Production
To receive $40 million in funding to help advance access to Quantoom Biosciences’ mRNA research and manufacturing platform.
10.12.23
Breaking News
|
cGMP Manufacture
|
Fill/Finish
|
Promotions & Moves
MG America Names Toby Spohn Regional Sales Manager
Spohn to handle sales for company’s capsule fillers, checkweighers, and material handling solutions.
10.12.23
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Drug Discovery
|
Facilities
|
Industry News
Axplora Granted cGMP Approval from AIFA for Extended Production Capacity
Designed to produce HPAPI and steroid batches up to 300 kg.
10.12.23
Breaking News
|
cGMP Manufacture
|
Collaborations & Alliances
|
Drug Development
Cellipont, Diakonos Oncology Partner on Glioblastoma Therapy
For the process development and cGMP manufacturing of DOC1021, an autologous dendritic cell vaccine.
10.11.23
Breaking News
|
cGMP Manufacture
|
Clinical Trial Materials
|
Drug Development
|
Industry News
Gritgen Therapeutics Launches Commercial GMP Facility in China
Validation and launch of operations at facility in Suzhou supports production of Gritgen's phase III clinical and commercial product for hemophilia A.
10.11.23
Biologics, Proteins, Vaccines
|
Breaking News
|
cGMP Manufacture
|
Industry News
Forge Biologics Chosen as AAV Manufacturing Partner for CIRM
Aims to help advance the manufacturing of adeno-associated adenovirus (AAV) gene therapy programs from California.
10.11.23
Biologics, Proteins, Vaccines
|
Breaking News
|
cGMP Manufacture
|
Collaborations & Alliances
|
Scale-up/Technology Transfer
Cellares, BMS Expand Cell Therapy Mfg. Technology Agreement
Cellares will optimize, automate, and tech-transfer the additional CAR-T cell therapy process onto its automated manufacturing platform.
10.11.23
cGMP Manufacture
Bayer Opens First Cell Therapy Mfg. Facility in Berkeley, CA
Will supply the material for late-stage clinical trials and potential commercial launch of BlueRock Therapeutics’ bemdaneprocel.
10.10.23
Breaking News
|
cGMP Manufacture
|
Collaborations & Alliances
|
Drug Development
|
Facilities
Centrient Pharma, Almirall Open Innovation Hub in Barcelona
Innovation Laboratory at Almirall's R&D facilities will leverage Centrient's manufacturing expertise.
10.10.23
Breaking News
|
cGMP Manufacture
|
Cold Chain Management
|
Collaborations & Alliances
|
Logistics
|
Supply Chain
Cryoport, CGT Catapult Partner on Cell and Gene Therapies
Cryoport will establish a global supply chain logistics center in the UK.
10.10.23
Breaking News
|
cGMP Manufacture
|
Information Technology
|
Promotions & Moves
Korber Names Kevin Stembridge Software BU Chief Product Officer
Stembridge will lead all functions related to the strategic alignment and product development for the Werum PAS-X MES.
10.09.23
Biologics, Proteins, Vaccines
|
Breaking News
|
cGMP Manufacture
|
Industry News
QHP Capital Acquires Applied StemCell
ASC’s platform of GMP-grade allogeneic iPSC and TARGATT gene editing technology provides shorter manufacturing timelines.
10.09.23
cGMP Manufacture
|
Drug Development
|
Promotions & Moves
Altasciences Names Angel Reyes CDMO Services GM
Reyes brings over a decade of experience in management and supervisory roles for manufacturing operations and supply chains.
10.06.23
Biologics, Proteins, Vaccines
|
Breaking News
|
cGMP Manufacture
|
Collaborations & Alliances
CTMC, ScaleReady Partner to Advance CGT Manufacture
Aims to help lessen the manufacturing barriers for cell and gene therapies by integrating cutting-edge automation tools.
10.05.23
Breaking News
|
cGMP Manufacture
|
Chemistry
|
Clinical Trial Materials
|
Collaborations & Alliances
|
Drug Development
|
Formulation Development
Delnova, Pace Life Sciences Partner on ReViVox Development
Will support clinical development of DelNova’s lead candidate ReViVox to reverse unwanted paralysis induced by BoNTs such as Botox.
10.05.23
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Industry News
|
Inspections
Quotient Sciences Concludes FDA Inspection of UK Facility
For the validation of three bioequivalence studies supporting licensing applications with the FDA.
10.05.23
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Facilities
|
Industry News
Wheeler Bio Opens Biomanufacturing Facility
Includes two single-use drug substance lines, warehousing, cold chain, a buffer and media prep suite, and two master cell banking suites.
10.05.23
Breaking News
Lilly Acquires Manufacturing Facility from Nexus Pharmaceuticals
Kühne Holding AG Agrees to Acquire Aenova Group
BigHat Biosciences Partners with Janssen Biotech to Guide Antibody Discovery & Design
Moderna and OpenAI Join Forces to Transform Healthcare with AI
CureVac Names New Chief Business Officer
View Breaking News >
CURRENT ISSUE
April 2024
Anti-Counterfeiting Technology
Navigating Global CDMO Trends
Weight-loss Drug Packaging
Clinical Supply CDMOs
Industry Experts Weigh in on Oral Solid Dosage
Newsmakers Q&A: Almac Group
Economical Mobile Workstations for Lower-Grade Cleanrooms
Pharmaceutical Manufacturing Equipment & Trends
Insight Into Obesity-Related Clinical Research
Inflation Reduction Act and the Impact on Biosimilars
View More >