Contract Manufacturing, General

Nov 01, 2008
BioPharm International
If Indian biologics manufacturers can establish a track record for recombinant products, enhance quality image, maintain cost competitiveness, and demonstrate technology transfer and regulatory knowhow, they are likely to be in the middle of the next boom in biologics manufacturing.
Nov 01, 2008
BioPharm International
There could be a serious glut of commercial scale mammalian cell culture capacity over the next five years. Then again, there could be a significant shortage. It all depends on how things develop in expression technology, the new product pipeline, and corporate strategies.
May 01, 2008
BioPharm International
The current overcapacity situation in the bio/pharmaceutical industry is a reminder that CMOs need to come up with business models and value propositions that are based on more than just selling capacity.
Apr 02, 2008
BioPharm International
When a biopharmaceutical company pursues an outsourcing strategy, the choice of a contractor is a critical and strategic decision.
Apr 02, 2008
BioPharm International
After a strategic evaluation of what activities to outsource, sponsor companies should follow key guidelines for selecting and auditing a provider and preparing quality agreements.
Apr 02, 2008
BioPharm International
The outsourced service provider should be considered an extension of your own laboratory.
Apr 02, 2008
BioPharm International
There are several considerations to keep in mind when auditing an outsourcing provider.
Oct 09, 2007
BioPharm International
By BioPharm International Editors
Discovery Laboratories (Warrington, PA) could see the end of its struggle to launch its Surfaxin (lucinactant) drug on the US market soon, as the manufacturing issues it has faced have been resolved.
Oct 09, 2007
BioPharm International
By BioPharm International Editors
Cobra Biomanufacturing is an international full-service manufacturer of biopharmaceuticals, dedicated to designing robust processes that deliver biopharmaceutical products to its life sciences customers for preclinical through Phase 3 studies.
Aug 21, 2007
BioPharm International
By BioPharm International Editors
The US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) issued a revised draft guidance on July 20 to help ensure that the safety, purity, and potency of biologics products is not compromised as a result of innovative, flexible manufacturing arrangements.
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