Biologic Drugs

Mar 01, 2006
Pharmaceutical Technology Europe
Human plasma provides a rich source of therapeutic medicines, including gamma globulins, coagulation factors, albumin, alpha anti-trypsin and others. In 2001, sales of immuno gamma-globulin (IgG) were estimated at $2 billion with a production rate of 50 metric tons for the year.1 A number of therapeutic products have been introduced including Gammimune from Bayer, RhoPhylac from ZLB Behring and Octagam from Octapharma.
Nov 07, 2005
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
When it comes to developing a robust lyophilization process, formulators can "pay now or pay later," says Jeff Schwegman, PhD, founder and chief scientific officer for BioConvergence. Because 30% of new drugs in clinical trials are biotech-based therapeutics (compared with 7% 10 years ago), more than ever, the US Food and Drug Administration is paying close attention to lyophilization data and questioning pharmaceutical companies about their development cycles, especially cycle development transfer, shelf-temperature mapping, dryer-to-dryer comparison studies, formulation time, process validation, and cycle deviation. Consequently, this is pushing formulators to optimize formulation variables, conduct additional testing during early-stage development, and understanding critical process parameters, equipment qualifications, and manufacturing conditions that can influence formulation behavior at a large scale. Not taking the time or effort to achieve these goals during early development could lead to redundancies in formulation work - a reality observed too often in today's practices.
Nov 01, 2005
Pharmaceutical Technology Europe
Biomanufacturing managers believe the current lack of adequately trained personnel is one of the most serious problems facing the biomanufacturing industry.
Oct 27, 2005
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Industry, FDA, and World Health Agencies Boost Pandemic Preparedness
Oct 06, 2005
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Collaboration Targets Single-Shot Japanese Encephalitis Vaccine
Sep 02, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
A fleet of pharmaceutical manufacturers have green lighted new bar coding and e-pedigree pilots using electronic barcodes. But is Industry ready for full-scale RFID?
Sep 01, 2005
Pharmaceutical Technology Europe
Contract manufacturers serving the biopharmaceutical market add capacity in a bet on renewed growth for biomanufacturing.
Aug 02, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Being the first to gain the most is a fundamental principle in the generics business because several companies compete to create generics of successful products going off patent. For a generics company to maintain revenue growth in a market in which product prices continue to fall, it must secure a continuous flow of new products, with quality and speed to market being key drivers. Thus, generics companies must be highly skilled in product and process development (1), the generics business, and achieving bioequivalence—the most critical development area.
Jul 28, 2005
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Protein Refolding Technology Improves Yields
Jul 28, 2005
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Collaboration Aims to Improve Actinomycete-Based Pharmaceutical Production
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