Manufacturing, Aseptic Processing

Jun 01, 2008
BioPharm International
By BioPharm International Editors
The industry needs to open up to validation failures.
May 01, 2008
BioPharm International
By BioPharm International Editors
Recent problems with food and pharmaceutical ingredients sourced from China highlight a major disadvantage of our complex international supply chains for food and drug ingredients. A global supply chain offers more opportunities for accidental contamination as well as intentional adulteration and counterfeiting. Sticking to minimal requirements may not be enough.
Apr 01, 2008
BioPharm International
The heparin safety crisis puts a spotlight on manufacturing processes and regulatory oversight.
Apr 01, 2008
BioPharm International
A case study investigated the root cause of failures in sterile filtration by evaluating the effects and interactions of four operating parameters.
Mar 01, 2008
BioPharm International
By BioPharm International Editors
Need a standard to follow? Just ask, What would Genentech do?
Feb 01, 2008
BioPharm International
Best practices from Big Biotech, including how to handle new product introductions.
Sep 01, 2007
BioPharm International
By BioPharm International Editors
Jul 24, 2007
BioPharm International
By BioPharm International Editors
The US Pharmacopeia (Rockville, MD, USP, www.usp.org) recently announced that the implementation period for its USP­–NF general notices statement requiring all manufacturers to conform to recently revised residual solvent standards in General Chapter <467> has been extended from July 1, 2007 to July 1, 2008.
May 01, 2007
BioPharm International
Membrane-based chromatography technologies sometimes offer advantages over resin-based technologies.
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