Search results for "biopharm"

Article Quality Systems Key to Lifecycle Drug Management
FDA officials plan to try again to offer regulatory relief in filing supplements and also in undergoing plant inspections for those biopharma companies that implement QbD and advanced manufacturing te…

Article Host-Cell Protein Measurement and Control
Article Details BioPharm International Vol. 28, No. 6 Pages: 32–38 Citation: When referring to this article, please cite it as F. Wang, D. Richardson, and M. Shameem, “Host-Cell Protei…

Article Advanced Technologies Facilitate Scale-up and Technology Transfer
Challener BioPharm International Volume 28, Issue 6, pg 20-23 It is hard to believe, but the biopharmaceutical industry is already old enough to have aging facilities that are decades ol…

Article Biomanufacturing Outsourcing Globalization Continues
Langer BioPharm International Volume 28, Issue 5 Biopharmaceutical manufacturing clusters continue to emerge outside of the traditional hubs of North America and Western Europe. Contract m…

Article Optimization of Protein Expression in Escherichia Coli
Article Details BioPharm International Vol. 28, No. 5 Pages 42–44 Citation: When referring to this article, please cite is as S. Bashiri et al., "Optimization of Protein Expression in Escher…

Article Drug Discovery and Development in India
In addition, venture capital and private equity have not been actively supporting such biopharmaceutical start-ups, leaving such companies to turn towards larger multinational pharmaceutical companies…

Article USP Publishes Monoclonal Antibody Guidelines
Morris, PhD BioPharm International Volume 3, Issue 28 As FDA gears up towards approving biosimilar drugs in the United States, it is unquestionable that the role of biologics has rapidly expa…

Article Finding Opportunities in Brazil
Article Details BioPharm International Vol. 28, Issue 2 Pages: 26-27 Citation: When referring to this article, please cite it as H. Berger, "Finding Opportunities in Brazil," BioPharm

Article The Bullish Outlook for Biosimilars
Kuchenreuther, PhD BioPharm International There are several important reasons for stakeholders to be optimistic about prospects for biosimilars. During the past few years, questions about th…

Article Quality by Design and Extractable and Leachable Testing
Feb 01, 2015 By Anthony Grilli BioPharm International Biopharmaceutical packaging performs several vital functions in assuring the drug product safety. First and foremost, packaging must b…

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