Pharmaceutical Technology-04-02-2006

New biocatalytic and chemocatalytic routes to chiral intermediates and developments in simulated-moving-bed and supercritical-fluid chromatography for resolving racemic mixtures.

The need to curb drug counterfeiting is spurring development of track-and-trace and product authentication technologies.

Hubert J.P. Schoemaker and William T. McCormick. Perhaps we could have not a special day, but just a moment to remember what we owe and who we we owe it to.

Recent deals suggest companies are willing to pay up to get into CMC services.

Eisai plans $105-million plant. Novartis to build plant in China. BMS building $660-million biologics facility. Slow adoption of RFID. Vaccines update. $14.7 billion in pharma construction in 2006. Chiron sells Betaseron to Schering. Baxter to develop cell based H5N1 vaccine. Drug sales up 5.4%, but growth slowing.

Performing D-value and population verification is critical in the acceptance criteria for allowing a new lot of biological indicators into a facility before acceptance and use of the lot in validation work or routine monitoring of sterilization cycles.

Despite worries that industry is slow to adopt anticounterfeiting technologies, the 2006 Interphex program is rife with new methods for securing the supply chain.

Absorption promoters and enhancers and enzyme inhibitors, either alone or in combination, can play an important role in improving the bioavailability of oral insulin.

Guidance for reducing the risk of dissolved ozone measurement and addresses proper installation, calibration, and verification to ensure the best possible answers from dissolved ozone analysis.

Senior management must be the champions of change in companies that are struggling financially or organizationally.

Vitamin D and a sunny window shed som light on product stability.

Cell-culture technology and financial incentives give influenza vaccine makers a much-needed shot in the arm, but many downstream processing issues remain unaddressed.