Biologic Drugs

Jan 25, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
The US Department of Health and Human Services (HHS, Washington, DC) has awarded three vaccine makers a total of $132.5 million to advance their strategies for adjuvant-containing vaccines to combat the H5N1 strain of avian influenza. Under the contracts, each company will build capacity to produce either 150 million does of the vaccine or enough adjuvant for 150 million doses within six months after the onset of an influenza pandemic.
Jan 01, 2007
Pharmaceutical Technology Europe
There are currently several hundred biotech-based drugs in clinical trials, representing around a quarter of all drugs in development — a proportion that looks set to increase.
Jan 01, 2007
Pharmaceutical Technology Europe
The concept of quality should not only apply to the manufacture of the media — it should also continue throughout the product's lifetime of usage.
Dec 18, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Biotechnology stocks dropped 14% in 2006, giving up more than half of the value they'd picked up during a "stellar" 2005, according to G. Steven Burrill, CEO of Burrill & Company (www.burrillandco.com), the venture and merhant banking company. "Overall, it wasn't a great year for biotech," said Burrill in a year-end analysis, indicating that the biotechnology industry will finish the year with its collective market capitalization essentially unchanged, at approximately $490 billion.

As for the future, biotechnology will continue to fuel a the transformation in healthcare, a tansformation emphasizing earlier disease detection, more targeted treatments, and adjunctive support through enhanced nutrition. We will see further progress on the personalized, predictive, preventative front...with new products targeting the "individualization" of medicine in the marketplace. Other predictions for 2007 include...

Dec 15, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Basel, Switzerland (Dec. 5)-Lonza Group Ltd. and Singapore?s Bio*One Capital have formed a joint venture, Lonza Biologics Tuas, to build a large-scale mammalian cell-culture facility in Singapore for as much as $350 million.
Dec 15, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Washington, DC (Dec. 13)-After considerable debate and negotiation, Congress this week passed four bills poised to affect pharmaceutical and biotechnology research, development, and manufacture. All are currently awaiting signature by the President.
Dec 02, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Makers of injectable drugs can increase their market share and stay competitive by devising a product life-cycle management strategy.
Dec 01, 2006
Pharmaceutical Technology Europe
The needle and syringe have long been the standard delivery technology for vaccines. However, a confluence of market factors is driving new interest in alternative delivery systems that hold the potential to meet one or more of the following goals: improved antigen utilization, higher quality immune response, better stability and improved patient acceptance. Of particular interest are microneedle systems, otherwise referred to as microstuctured transdermal systems (MTS), that provide for targeted delivery of the vaccine formulation directly to antigen-presenting cells within the epidermis. This article provides a brief overview of MTS technology with an emphasis on solid-coated MTS for vaccine delivery.
Dec 01, 2006
Pharmaceutical Technology Europe
Why do the biotech ventures mange to have such promising drug candidates while pharmaceutical R&D is facing a drug deficit?
Dec 01, 2006
Pharmaceutical Technology Europe
Virus safety of biotech- and plasma-derived therapeutics is ensured through complementary manufacturing and quality control measures that include the control and monitoring of raw materials, the validation and implementation of effective virus clearance technology and the monitoring of final filled product for the presence of virus. Virus filtration, which is considered a robust and effective virus clearance technology, is a common unit operation in the manufacture of biologicals. In this article, we review the points that must be considered when selecting a virus-retentive filter. The areas covered include regulatory considerations; selecting, optimizing and validating a virus filtration step; and process scale implementation — areas that are critical to users of virus filters.
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