Search results for " analytics"
Article
USP Publishes Monoclonal Antibody Guidelines
Mar 02, 2015
By Dale Schmidt, M.S., Anita Y. Szajek, PhD, Fouad Atouf, PhD, Tina S. Morris, PhD
BioPharm International
Volume 3, Issue 28
As FDA gears up towards approving biosimilar dru…
Article
Labeling of Biosimilars
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.
Feb 01, 2015
By Sean Milmo
BioPharm International
The European Medicines Agency (EMA) has r…
Article
Evolution of the Monoclonal Antibody Purification Platform
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline…
Article
Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
Levine whether he thought developers would be able to be fairly flexible in how they characterize or whether, as a result of the new guidelines, they would be pigeon-holed into a standard set of analy…
Article
Address the complexity of protein characterization
Since the FDA approved the first monoclonal based therapy in 1985, mAbs have had significant clinical success and have been used to provide effective treatment for a range of diseases. Durin…
Article
Process Development and Control for New Modalities
Increasing molecular diversity leads to more challenges in process development and control. Advancements in technology for manufacturing and online analytical monitoring have not caught up…
Article
What is process development?
Those activities must be combined with the right analytics, so you can accurately measure what you’ve identified as your product’s critical quality attributes (CQAs) as you develop and refine your pro…
Article
What’s in your media? How costly is variability of cell culture media to your manufacturing process?
Manufacturing
In this video, Christopher Woolstenhulme, Lead Analytical Scientist of Manufacturing Sciences at Cytiva, is interviewed by BioPharm International and provides insight into t…
Article
Analysis of mRNA Therapeutics and Vaccines
Analytical approaches must keep pace to ensure the identity, safety, and efficacy of evolving mRNA candidates.
Read more here >>>
Article
Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
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Gunnar Malmquist, Senior Principal Scie…