Search results for " Scale-up" in Articles / App Notes

Article Single-use Bioreactors Have Reached the Big Time
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations. By Cynthia A. Challener Single-use bioreactors available from various vendors…

Article Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
The year ahead is expected to be marked by increased biosimilar development, lower drug prices, and better quality drugs. The global biopharmaceuticals market was valued at $162 billion in 2014 a…

Article Improving Process-Scale Chromatography
Advances in technology are increasing the productivity and efficiency of commercial-scale chromatography bioprocesses. By Cynthia Challener, PhD Chromatography is a crucial step in the purif…

Article Perfusion in the 21st Century
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing. By Bruce Lehr, Delia Lyons Cell-culture technology for biopharmaceutical manufact…

Article A Q&A with Eric Langer: CMOs Embrace New Technology
Process Development Forum speaks with Eric Langer, President and Managing Partner at BioPlan Associates, and the author of a number of biopharma studies, about the 2016 13th Annual Report and Survey…

Article Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients. By Jill Wechsler FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …

Article Taking a “Development-by-Design” Approach to Cell Therapies
Jun 15, 2015 By Agnes Shanley BioPharm International eBooks Volume 28, Issue 13 Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, c…

Article Quality Systems Key to Lifecycle Drug Management
Jun 01, 2015 By Jill Wechsler BioPharm International Volume 28, Issue 6 The submission and review of manufacturing supplements is costly and time consuming for biopharmaceutical comp…

Article Modern Manufacturing Systems Key to FDA Quality Initiative
Apr 02, 2015 By Jill Wechsler Pharmaceutical Technology Volume 39, Issue 4 To ensure patient access to high quality, safe, and effective medicines, FDA spends considerable time and resou…

Article Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 4 Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …

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