Validation and Compliance

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.
Nov 10, 2016
BioPharm International
This article demonstrates that a modified SDS–PAGE can be easily used as a tool for quantifying the degree of protein degradation.
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The agency publishes draft guidance on assay development and validation for immunogenicity testing.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.
Oct 02, 2015
BioPharm International eBooks
Can alternative approaches to the permitted/acceptable daily exposure be justified?
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