Validation and Compliance

Nov 01, 2017
BioPharm International
This article demonstrates that a modified SDS–PAGE can be easily used as a tool for quantifying the degree of protein degradation.
Sep 26, 2017
By BioPharm International Editors
UPS has revealed a new system to improve drug supply chain security, in compliance with the Drug Supply Chain Security Act (DSCSA).
Aug 01, 2017
BioPharm International
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
Jul 01, 2017
BioPharm International
The opening presentation gives the company a chance to put their best foot forward, according to Siegfried Schmitt, principal at PAREXEL.
May 01, 2017
BioPharm International
Can bioprocessing runs be consistently replicated in an inherently variable production environment?
Apr 25, 2017
By BioPharm International Editors
Lonza revealed it received a warning letter from FDA for its cell therapy manufacturing plant.
Jul 01, 2016
BioPharm International
The author provides a review of the concepts of design and qualification that apply to single-use systems.
Jun 01, 2016
BioPharm International
An understanding of continued process verification can lead the way to consistent approaches, reduced investigation times and observations, the avoidance of lost batches, and high-quality products.
Apr 25, 2016
By BioPharm International Editors
The agency publishes draft guidance on assay development and validation for immunogenicity testing.
Dec 07, 2015
While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.
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