Search results for " characterization" in Articles / App Notes

Article Scaling Up Novel Therapies
Scaling Up Novel Therapies Platform processes have improved monoclonal antibody scale-up. Can they do the same for personalized therapies? By Agnes S…

Article Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…

Article Modern Manufacturing Key to More Effective Vaccines
Modern Manufacturing Key to More Effective Vaccines Accelerated development of new preventives raises challenges for efficient CMC evaluation and production. By Jill Wechsler …

Article Transformative Medicines Challenge FDA and Manufacturers
Transformative Medicines Challenge FDA and Manufacturers New gene therapies and combination products require innovative regulatory approaches. By Jill Wechsler …

Article Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins This study outlines methods for an alternative protein-polishing process for challenging proteins. …

Article Modeling and Miniaturization: Key Topics at Successful HTPD Conference
Modeling and miniaturization were two key take-home messages from the 4th High Throughput Process Development (HTPD) conference organized in October 2017 in Toledo, Spain. The conference brought tog…

Article From Darwin to Recombinant Fc Multimers
Topics from a Darwinistic viewpoint on how business models are evolving in the Life Science industry to breakthrough research data from Momenta Pharmaceuticals on a recombinant trivalent Fc protein …

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 Selecting the Right Viral Clearance Technology
By Cynthia Challener, PhD The introduction of adventitious viral agents is a recognized, inherent risk of biologic drug production that is well addressed by international regulatory requirements…

Article Breakthrough Drugs Raise Development and Production Challenges
Manufacturers and FDA look for innovative strategies to meet accelerated timeframes. Jul 01, 2015 By Jill Wechsler BioPharm International Volume 28, Issue 7, pg 8–9 The FDA pro…

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