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By Tim Sandle, Ph.D.
The FDA issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.
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By Matthew Pillar, Editor, Bioprocess Online
Amidst the dealmaking and spectacle of the 41st Annual JP Morgan Healthcare Conference, a bright and personal light was cast on the value of a different kind of collaboration: drug repurposing. There’s a deep vein of patient benefit sitting on pharmacy shelves, and Michael Fajgenbaum, M.D. wants to tap it.
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Article
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Qosina Corporation
Understand the difference between a validated sterile claim and a low or zero bioburden microbial control claim on single-use systems and where each fits into biopharmaceutical manufacturing processes.
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Article
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By Natasha Van Rutten,
Catalent
Understand how formulation development for a prefilled syringe affects manufacturing, driving the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.
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White Paper
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By Omar A. Salman, Ph.D.,
Pfizer CentreOne
Sterile suspensions are particularly difficult to manufacture. This technical article covers factors for success, including particle size, vehicle formulation, and considerations for high-shear mixing.
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Case Study
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AGC Biologics
An established cell line and a bench-scale manufacturing process for a complex glycoprotein produced high-quality material but had a low yield and was not scalable.
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e-book
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Sartorius
We discuss the challenges and opportunities when developing a media approach and explore the benefits of partnering with a provider with expertise throughout the media pipeline.
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e-book
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CPC
Practical information on key issues including extractable/leachable testing in components, freeze/thaw in single-use assemblies, efficiencies driven by SUT advances such as genderless connectors, and more.
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Article
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By Brian Hubbard and Duncan Low,
Purolite, An Ecolab Company
Learn about regulatory pathways for introducing biopharmaceutical process improvements and/or alternate sources of chromatography resins.
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White Paper
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Precision NanoSystems
Learn about the considerations and challenges of using ionizable lipids, including the five types of lipids used for RNA delivery.
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Poster
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By Linnea Troeng, Matthew Townsend, et al.,
Cytiva
Rapid cycling, using Fibro PrismA units together with an ÄKTA pure™ system and an autosampler, offers new opportunities in high-throughput purification for screening of lead candidates and process conditions.
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e-book
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FUJIFILM Wako Chemicals U.S.A. Corp.
Exosomes have recently been attracting research interest. This guidebook is a useful resource for exosome researchers seeking high-purity isolation.
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Webinar
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Lonza
Explore the needs of more complex candidates through case studies that demonstrate the range of expression capabilities across mammalian and microbial-derived molecules.
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White Paper
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By Mariana Brena, Christopher Parker, and Michael Mrvos,
Cambrex
Cleaning procedures designed specifically to destroy microbial contaminants that may be present are an important component of any microbial control strategy.
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White Paper
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By Kate Green,
Pall Corporation
We review an automation system that is based on a standard technology platform, with standardized hardware, networking, and software elements and designed to securely connect to end-user networks.
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Ajinomoto Bio-Pharma Services
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West Pharmaceutical Services, Inc.
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Have you heard of Life Science Leader?
Check it out today for access to candid interviews with top-tier executives on how they do business.
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