Search results for " GMP manufacturing"

Article GMP Challenges for Advanced Therapy Medicinal Products
“[Our own data] has consistently shown that GMP manufacturing knowledge remains a barrier for academic triallists aiming to perform the full cycle from preclinical investigations to early and subseque…

Article Applying GMPs to the BioPharma Supply Chain
Defining best biopharmaceutical practices is necessary to ensure the safety of the supply chain. Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be availab…

Article Applying GMPs in Stages of Development
Applying GMPs in Stages of Development Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, …

Article Step Up to GMP Manufacturing or Outsource to a CDMO: Considerations and Tips
Whether you are developing a new monoclonal antibody (mAb), cell therapy, gene therapy, or large-molecule biologic drug, the decision to tackle GMP manufacturing in-house or work with a contract devel…

Article Continuous Manufacturing: A Changing Processing Paradigm
There are also some worries about the overall novelty of the technology in the continuous space, as not all equipment needed to perform continuous processes may yet be available for GMP manufacturing.…

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
Bioterminology: A Guide to the Biopharmaceutical Lexicon This lexicon was generated by the editors of BioPharm International magazine. Please feel free to email your suggestions for terms that s…

Article Modular Manufacturing Platforms for Biologics
May 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 5 It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…

Article Industry Adoption of Single-Use Systems Remains Low
…ally automated, flexible biomanufacturing platform based on single-use technologies, that allows for GMP manufacturing. The acquisition complemented GE Healthcare’s portfolio with production-scale bi…

Article Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics. By Susan Haigney Editor's note: The following is an extended version of the…

Article Quality by design for biotechnology products—part 3
Guidance from the Quality by Design Working Group of the PhRMA Biologics and Biotechnology Leadership Committee on how to apply ICH Q8, Q8R1, Q9, and Q10 to biopharmaceuticals. By Taruna Arora, …

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