Biologic Drugs

Nov 22, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Washington, DC (Nov. 20)-The US Department of Health and Human Services awarded contracts totaling $199.45 million to Sanofi Pasteur, Novartis, and GlaxoSmithKline PLC to manufacture 5.3 million 90-?g doses of influenza vaccine designed to protect against the H5N1 influenza virus strain.
Nov 16, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Research Triangle Park, NC (Nov. 13)-Eisai Inc. broke ground here for a new pharmaceutical production and formulation research and development facility for parenteral oncology drugs.
Nov 01, 2006
Pharmaceutical Technology Europe
The ¤9.5 billion therapeutic antibody market comprises over a dozen antibodies that have been generated using recombinant genetic methods developed over the last 20 years.
Nov 01, 2006
Pharmaceutical Technology Europe
Quality by design and PAT approaches are increasingly being used for the biotech manufacturing of medicines. Complex manufacturing processes can not only be controlled using PAT principles, but optimized with respect to both product quality and economic value. This column describes how the fermentation process is often the first to benefit from this type of implementation.
Nov 01, 2006
Pharmaceutical Technology Europe
Clean rooms are critical areas in bio/pharma facilities, and it is essential that users are responsible for their care and upkeep, and familiarize themselves with the relevant regulations.
Oct 26, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Robin Hwang, a senior principal scientist at Amgen (Thousand Oaks, CA), led the team that developed the first commercial disposable auto-injector for a biopharmaceutical: a prefilled three-step "SureClick" for delivering Enbrel (etanercept), a treatment for autoimmune diseases.
Oct 25, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
The US Food and Drug Administration issued a guidance document to provide manufacturers of biological products (other than blood and blood components) with its current thinking on reporting requirements on deviations from current good manufacturing practices for biological products.
Oct 03, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Biologics are forecast to account for roughly 60% of revenue growth through 2010 for Big Pharma as growth in small molecules slows. The author analyzes the factors driving demand and how the technology life cycles of these two sectors will affect market potential.
Oct 02, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Protein formulation specialists have long sensed that something big could be just around the corner. Over the past few decades, countless companies have attempted to bring to market new protein therapeutics that offer improvements—be they more patient friendly, more effective, or easier to manufacture—over traditional formulations. Earlier this year, the launch of Pfizer's "Exubera" pulmonary insulin met this anticipation head on. The fast-acting, inhaled-powder form of recombinant human insulin brought hope to the millions of diabetic patients waiting for an alternative to injections.
Oct 01, 2006
Pharmaceutical Technology Europe
UK science has an outstanding record and we remain strong internationally in terms of achievement, productivity and efficiency.
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