Search results for " transfer clinical phases"

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 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 Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals. The manufacture of biopharmaceuticals presents …

Article Science Focus Fuels Successful Process Development for Startups
Getting the science right helps biopharma startups overcome development and commercialization challenges. By Cynthia A. Challener sdecoret/Stock.Adobe.com Pr…

Article Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends. With the dawn of the 2…

Article Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3 Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…

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 Lessons Learned Accelerate Vaccine Development
Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing. By Cynthia A. Challener Vaccine development is a complicated process that can take many yea…

Article The Development and Application of a Monoclonal Antibody Purification Platform
A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies. The following ar…

Article Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development. By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig C…

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