Search results for " containers"

Article Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics. By Robert Karlsson Abstract Biotherapeutic antibodies are still the larg…

Article Selecting a Comprehensive Bioburden Reduction Plan
Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination. By Randi Hernandez There are multiple variables to consider …

Article Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Optimization of each phase in a chromatographic cycle has a positive impact on productivity. By Anna Grönberg An important area of focus for the biopharma industry is the elucidation and dev…

Article Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API. By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…

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…

Article Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed. Jul 01, 2015 By Susan Haigney BioPharm International Volume 28, Iss…

Article Host-Cell Protein Measurement and Control
Jun 01, 2015 By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem BioPharm International Volume 28, Issue 6, pg 32–38 Host-cell proteins (HCPs) constitute a major part of proce…

Article Advanced Technologies Facilitate Scale-up and Technology Transfer
Single-use and modular technologies plus continuous manufacturing are increasingly important to biopharma scale-up and tech transfer. Jun 01, 2015 By Cynthia A. Challener BioPharm Inte…

Article FDA Approves First Biosimilar
Mar 06, 2015 By Randi Hernandez BioPharm International FDA approved Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. The approval is a groundbreaking decision, as Sandoz is the firs…

Article The Bullish Outlook for Biosimilars
Feb 01, 2015 By Jill E. Sackman, PhD, Michael J. Kuchenreuther, PhD BioPharm International There are several important reasons for stakeholders to be optimistic about prospects for b…

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