Articles on FDA, regulatory policy, compliance, biosimilars/follow-on biologics - BioPharm International

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GMPs & Validation
What you need to know about regulatory compliance, good manufacturing practices (GMPs), and validation, including evolving regulatory policy and developments in biosimilars.

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FDA and Justice Department Address Drug Quality Concerns
February 1, 2012
A Risk-Based Approach to Transferring a Mature Biopharmaceutical Process
February 1, 2012
The Drive for Best Practice in Biopharmaceutical Manufacturing
February 1, 2012
Saving the Next Generation of Regulatory Scientists
February 1, 2012
PQRI Case Study: Facility Biocontainment and Inactivation
February 1, 2012
Addition Vessels
Bioengineering AG
Biosimilar Development: From Science to Market
February 1, 2012
High-Resolution, Fast MAb Charge Variant Analysis
January 31, 2012
Quality By Design in Biomanufacturing Bioproduction Group
January 31, 2012
Mass Spectrometry Compatible Separation of Itraconazole Substances by UHPLC
December 27, 2011
Rapid Screening of Sialic Acids in Glycoproteins by HPAE-PAD
November 29, 2011
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