In the pursuit of operational excellence and continuous improvement, it is important to consider the role of people and culture in driving long-term success.
Will receive one year of lab space at BioLabs LA at The Lundquist Institute and additional facility benefits and connections to Amgen's scientific leaders.
The importance of reagent quality control, especially endotoxin testing, during CGT development and the selection of reagents and suppliers to ensure safety.
Garrett Perry, Technical Services Specialists at Teknova09.14.21
Emerging innovations and non-antibiotic approaches to address urgent need to control infectious diseases, including multiple-drug resistant ‘super-bugs’.
Merilee Kern, MBA, Brand Analyst, Strategist and Futurist, and Forbes Business Council Member09.09.21
Spray drying is an established particle engineering technology that offers several advantages over other methods used for improving API bioavailability.
Dry granulation can be a method to overcome caking issues and improve handling of buffers, salts and stabilizing chemicals during pharmaceutical manufacturing.
Designed for packaging development, materials testing and production, the unit performs forming, sealing and punching operations at sequential stations.
Alex Garner will work to further expand and strengthen Avomeen’s formulation and clinical trial manufacturing capabilities to support biopharmaceutical clients.
Emerging innovations and non-antibiotic approaches to address urgent need to control infectious diseases, including multiple-drug resistant ‘super-bugs’
Collaboration will increase access to Actinium-225, a medical isotope used with radiopharmaceutical drugs in clinical trials for advanced cancer therapy.
Anshul Gupte will be responsible for technical and scientific oversight of client projects, reporting to John Ross, President of Metrics Contract Services.
Bikash Chatterjee of Pharmatech Associates discusses the reshoring trend, technologies and advances that could help deliver more manufacturing back to the U.S.
State-of-the-art R&D lab at Florence, KY site expands technical feasibility capabilities for long-acting delivery of small molecules, biologics and nucleotides.
Designed to provide a fast, sensitive range of trace element analysis solutions capable of capturing the complete spectrum of high matrix samples in single run.
Designed to offer full control of filling parameters in single or dual operation and provide accurate, consistent fills at a rate of up to 12 pieces per minute.
Initial phase includes installation of two 2,000-liter single-use bioreactors and associated investments to support early-and late-phase clinical development.
Cloud-based application allows verification of multiple clinical research sites’ source data to be completed remotely by specialist team at centralized location
Strengthens cell therapy pipeline with individualized solid tumor Neoantigen TCR cell therapy R&D program and adds manufacturing footprint in North America.
Brings together THREAD's digital platform and Marken's clinical trial logistics services to create a single seamless workflow for clients and patients.
Acquisition is part of the cigarette maker’s ‘Beyond Nicotine’ strategy and expands its product pipeline development capabilities in inhaled therapeutics.
Will leverage integrated services from Selexis and KBI as part of Immatics’ development of TCR Bispecifics, designed to detect, target and attack tumor cells.
New product, Corning Valor RTU Vials with SG EZ-fill Technology, offers a unique combination of Corning Valor Glass vial attributes with SG EZ-fill integration.
Arecor will use its proprietary formulation technology platform to develop a differentiated, thermostable formulation of one of Lilly’s proprietary products.
Will integrate Cryoport's Cryoportal Logistics Management Platform and LabConnect's SampleGISTICS platform to provide Triumvira with advanced logistics support.
How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.
CDMOs have been some of the biggest winners from COVID contracts and will see benefits for several more years to come. A Q&A with GlobalData’s Peter Shapiro.
Lonza’s Robert Beland discusses best practices for manufacturers to shorten development timelines, as well as some of the capabilities at the CDMO's Tampa site.
ProBioGen to provide cell line development, process development and GMP manufacturing at 1000 L bioreactor scale of Asher's lead immuno-oncology candidate.
Increases capabilities and capacity to provide anti-infective testing, assay development and biomaterial production services for highly infectious pathogens.
Aims to provide improved product tracking, scheduling and live monitoring of the manufacturing status across the entire CGT supply chain from vein to vein.
How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.
New site in Haimen, Jiangsu province has been established following an invitation to participate in the Yangtze Delta Advanced Drug Development platform.
Lonza exits both softgels and liquid-filled hard capsules and NextPharma plans to broaden its technology offering into lipid based finished dosage forms.
More robust solutions for single-use cold-chain containers made with polytetrafluoroethylene fluoropolymers may be less susceptible to failure and breakage.
Recognizes manufacturing facility and processes are in compliance with GMP requirements and readiness to provide commercial aseptic fill/finish services.
Exclusive license agreement to incorporate Ajinomoto Co.’s AJICAP site-specific bioconjugation technology for the development of Bright Peak Immunocytokines.
Jointly develop systemic lupus erythematosus assessment review process to enhance data quality and research site personnel experiences and efficiencies.
To show the impact to autologous and allogeneic cell therapies by integrating novel transfection technology with other steps in the manufacturing process.
35-year pharmaceutical industry veteran brings deep industry expertise and a track record of building successful, client-centric, growth organizations.
Will increase 7000L drug substance capacity (MFG21) and drug product capacity (DP11) for liquid and lyophilization within its global manufacturing network.
Dendritic cell vaccine production capacity for personalized immune therapies increases from about 4 - 6 patients per month to about 40 - 45 patients per month.
Overcoming challenges of implementation and achieving increased volume, reduced timelines, decreased footprint, lower cost of goods, and increased flexibility.
Priyanka Gupta, Head of Market Entry Strategy for Protein Based Therapeutics, Sartorius03.09.21
rfXcel’s AI-enabled SaaS platform more than doubles Antares Vision’s software business and adds a high share of contracted, recurring and scalable revenues.
The existing partnership for manufacture of NVX-CoV2373 has been expanded to increase production capacity and supply vaccines to the Korean Government.
Exclusive worldwide license and development agreement will leverage Biomunex' next gen bi- and multi-specific antibody platform in hematological malignancies.
Dr. Murphy of ICON, provider of clinical services to Pfizer/BioNTech’s COVID vaccine program, discusses what it takes to conduct a vaccine trial of this scale.
Newly launched medicines Tecentriq, Hemlibra, Ocrevus, Perjeta and Kadcyla offset the impact of competition from biosimilars for established medicines.
Will focus on clinical and commercial clients, especially as Cognate expands its business with allogeneic and autologous on-demand cell and gene therapies.
Treatment could be used for people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease, complementing the vaccine.
Read how Syngene's partnership with a leading Biotech company working in the field of cancer therapy grew from one small pilot project to over 100 FTEs today.
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 Groups01.05.21
With vaccines against COVID-19 on the horizon, our focus is shifting to 2021 and the major issues life sciences companies face and reasons for optimism.
Arda Ural , EY Americas Health Sciences and Wellness Industry Leader, Ernst & Young LLP12.11.20
Large shipping system capable of carrying thousands of doses of vaccines that may require temperatures as low as -80° C using liquid nitrogen technology.
Expect to produce globally up to 50 million doses in 2020, up to 1.3 billion doses by the end of 2021; ready to distribute within hours after authorization.
Instead of closing its doors on China, Western pharma industry needs to take a balanced approach and perform proper due diligence based on objective criteria.
The labeling process is highly complex and constantly in flux, making it ideal for digital transformation, but AI and ML cannot be implemented overnight.
Kiran Chinnalla, Associate Director Global Regulatory Affairs, Julian Backhouse, Associate Director Regulatory Technology Product Management, Cham Williams, Associate Director Business Systems , IQVIA11.13.20
Single-dose intranasal vaccine for COVID-19 designed to generate a broad immune response with nasal mucosal immunity to prevent infection and transmission.
As a partner to the U.S. Government, GRAM's newest facility was designed to increase large-scale fill and finish capacity with room to expand as demand grows.
Offering now includes Clinical Site-to-Patient, Pharmacy-to-Patient and Depot-to-Patient services to enable medication delivery directly to patients' homes.
Karen will work to further expand the company's contract manufacturing business, which delivers GMP materials to third parties developing COVID-19 vaccines.
Fran L. DeGrazio of West discusses why and how vaccine development is different than drug development and the impacts of COVID-19 on vaccine development.
Launches PyroCell MAT System for in vitro Pyrogen testing to help ensure safety of parenteral pharmaceuticals during development, manufacture and release.
Dr. Ural of Ernst & Young LLP discusses market dynamics, enduring therapeutic areas, near term M&A, and how industry can use this time for transformation
Backed by major pharma, the toolkit aims improve data management and data sharing, supporting AI and machine learning to advance the Lab of the Future.
Jeffrey Bailey has led both public and private healthcare companies leveraging his leadership experience in commercial, supply chain and business development
Matt David, M.D. has more than 15 years of experience in finance as a healthcare investment banker and earlier as an equity analyst covering the pharma sector
Serge Bodart of IDDI provides insight on the pharma and biopharma trends impacting CROs, outsourcing in today’s market, and advances in clinical research.