Biopharma Outsourcing Activities Update
April 20, 2014 - Eric Langer, BioPharm International
Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.
Over the past
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Quality by Design—Bridging the Gap between Concept and Implemen
April 20, 2014 - Sean Milmo BioPharm International
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the E
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
April 20, 2014 - Cynthia Challener, PhD BioPharm International
Raw Material Variability
April 20, 2014 - Simon Chalk, BioPharm International
The biopharmaceutical industry is developing a new approach to controlling variability in raw materials.
Trends in BioPharma Approvals in 2013
April 7, 2014 - Gary Walsh, PhD , BioPharm International Magazine
In 2013, 20 products containing new biopharmaceutical molecular entities (defined herein as recombinant proteins, monoclonal antibody or biosynthesized nucleic acid
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Q&A with Industry Leaders: Rita Peters
April 4, 2014 - Process Development Forum
This week, Process Development Forum's new Q&A feature interviews Rita Peters, Editor of BioPharm International Magazine, about second quarter trends in dr
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Manufacturers Struggle with Breakthrough Drug Development
March 16, 2014 - By: Jill Wechsler BioPharm International
Biopharmace
Determining Criticality–Process Parameters and Quality Attribut
March 15, 2014 - By: Mark Mitchell BioPharm International
FDA and EMA Extend QbD Parallel-Assessment Pilot Program
March 15, 2014 - BioPharm International
FDA and the European Medicines Agency (EMA) have extended the joint pilot program for the parall
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Design of Experiments for Analytical Method Development and Valid
March 15, 2014 - By: Thomas A. Little, PhD BioPharm International
Design of experiment is a powerful development tool for method characterization and method validation.