Search results for " biologics development"

Article Ensuring the Quality of Biologicals
May 02, 2015 By Stephen Wicks, PhD Pharmaceutical Technology Volume 39, Issue 5 The European Pharmacopoeia (Ph. Eur.), which celebrated its 50th anniversary in 2014, provides common …

Article Critical Quality Attributes Challenge Biologics Development
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics. By Susan Haigney Critical quality attributes (CQAs) are used in biop…

Article Updating Viral Clearance for New Biologic Modalities
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities. By Feliza Mirasol Ensuring viral clearance (i.e., removal) in downstream purification has becom…

Article Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins. By Adeline Siew, PhD  CA-SSIS/shutterstock.comIm…

Article Improving PAT for Biologics
The complexity of biopharma processes requires innovative solutions. Dec 01, 2014 By Cynthia Challener, PhD BioPharm International A key component of the quality-by-design (QbD) ap…

Article Strategizing for Rapid Changeovers in Biologics Manufacturing
Olivier Le Moal/Stock.Adobe.com By Cynthia A. Challener  Facility and equipment design are important, but the team and its experience matter most. Through its Operation Warp Speed pro…

Article The Need for Advanced Process Modeling for New Therapeutic Biologics
The Need for Advanced Process Modeling for New Therapeutic BiologicsThe trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling e…

Article Modular Manufacturing Platforms for Biologics
May 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 5 It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…

Article Upcoming Technologies to Facilitate More Efficient Biologics Manufacturing
Choosing the right tools to enhance the process. By Xuemin Liu, Mike Collins, Nathalie Fraud, PhD, Jennifer Campbell, Inese Lowenstein, Karol M. Lacki and Anurag S. Rathore, PhD ABSTRA…

Article Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs Analytical exoglycosidases are transitioning from being largely academic tools to being s…

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