Manufacturing

Mar 01, 2008
BioPharm International
By BioPharm International Editors
India is restructuring its regulation of biopharmaceuticals to help the country's industry compete internationally.
Oct 01, 2007
BioPharm International
By BioPharm International Editors
It became a strategic imperative to find a better, more efficient way to manufacture our products. To continue with the status quo was untenable.
Aug 21, 2007
BioPharm International
By BioPharm International Editors
The US Food and Drug Administration's Nanotechnology Task Force (www.fda.gov/nanotechnology/ nano_tf.html) has released a report recommending the agency develop guidelines and take other steps to address the benefits and risks of products, including drugs and medical technology, that use nanotechnology.
Aug 01, 2007
BioPharm International
By BioPharm International Editors
The mounting threats of pandemic influenza, bioterrorism, and emerging infectious diseases continue to be the focus of research programs and funding initiatives, not only within governmental agencies, but also universities, private research firms, and commercial manufacturing entities. With all of these efforts, however, the question of manufacturing capacity and the ability to respond to pandemic and emerging threats continues to be a major concern.
Apr 01, 2007
BioPharm International
Scale-up issues leading to long development times and deviations in the commercial facility is a critical challenge.
Mar 22, 2007
BioPharm International
The United States Pharmacopeia (USP, Rockville, MD, www.usp.org) and the UK's National Institute for Biological Standards and Control (NIBSC, Hertfordshire, UK, www.nibsc.ac.uk) are seeking participants in a study of analytical methods used by the industry to characterize and quantify oligosaccharides.
Mar 22, 2007
BioPharm International
The biopharmaceutical industry has gained a lot of experience in monitoring glycosylation, but still has a lot to learn about the structure–function relationship.
Nov 01, 2006
BioPharm International
By BioPharm International Editors
Whether it's for manufacturing drugs, characterizing cell substrates, or regulating new technology, quality systems provide a needed framework.
Jul 01, 2006
BioPharm International
Food and Drug Administration is encouraging public–private collaborations to more fully explore the physical and chemical characteristics of nanoparticles.
May 01, 2006
BioPharm International
The sugars used to stabilize lyophilized proteins often have not been subjected to appropriate cGMP standards.
native1_300x100
lorem ipsum