Laura Bush

It seems clear that insuring the roughly 46 million Americans who are now uninsured will increase drug sales.

The US Food and Drug Administration announced yesterday that it has approved four vaccines against the 2009(A)H1N1 (?swine?) influenza virus.

Lonza (Basel, Switzerland), broke ground earlier this week on a new cell therapy manufacturing facility in Tuas Biomedical Park, Singapore, adjacent to Lonza?s large-scale mammalian manufacturing facility.

Novavax (Rockville, MD) recently achieved positive Phase 2a results for its trivalent virus-like particle (VLP) vaccine against seasonal influenza, and positive preclinical results for a VLP vaccine against H1NI (swine) flu.

If risk assessments only identify "the usual suspects," the process will not add much value.

ICH Q9 encourages companies to apply the concept of quality risk management. Easier said than done.

Protalix BioTherapeutics received approval from the US FDA on August 17 to proceed with its treatment protocol for prGCD, a development drug for Gaucher's disease.

SAFC Biosciences (St. Louis, MO) has developed a chemically defined cell culture supplement based on the characterization of hydrolysate components proven to provide cell growth and protein production capabilities equivalent to traditional undefined hydrolysate raw materials.

The prospect of conducting risk assessments, as part of the quality risk management strategy promoted by the International Conference on Harmonization (ICH) Q9 guideline, tends to evoke blank stares and confusion. It also prompts many questions: Which of the many tools-PHA, HACCP, FMEA, etc.-should we use?

Sartorius Stedim Biotech (Goettingen, Germany) and SAFC Biosciences (St. Louis, MO), a division of SAFC, have entered into a partnership to share expertise, support each other in developing custom solutions for customers, and generate data on the performance of equipment in different applications.