Pharmaceutical Technology-09-02-2005

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?

Poly(ethylene oxide) is gaining the attention of research and development organizations and its application is extending into a wide range of drug delivery systems.

Participants in a 2003 PhRMA workshop present the industry’s current thinking on developing analytical method equivalency, including the importance of sample selection, acceptance criteria, data evaluation, and documentation.

The pharmaceutical science education system must be transformed.

The US National Institute of Allergy and Infectious Diseases (NIAID, Bethesda, MD, www3.niaid.nih.gov) announced it will order two million doses of an avian influenza vaccine from Sanofi-Pasteur (Swiftwater, PA and Lyon, France, www. sanofipasteur.com). In April, the NIAID began a Phase I trial to evaluate the vaccine’s safety and ability to generate immunity against the H5N1 strain of avian flu, an illness that leads to severe disease and possible death in birds and humans.

Cephalon partners with hardware and software providers to test item-level tagging.

A summertime burst of acquisition activity in CMC development services prompts the question: a coincidence of timing or the start of a trend?

Technology's new monthly "Agent-in-Place" column distills true-life cautionary tales from the secret files of Control, a senior compliance officer.

Rapidly increasing cell-culture yields have thrown an increasing burden on downstream processes just as price pressures are pushing process developers to look for economies in every purification protocol. The time-honored, effective, and expensive war-horse, Protein A, is beginning to feel some competition from small-molecule mimetics.

Lean is good. Emaciated is something else.

Pharmaceutical science and technology innovation

Commissioner Crawford’s top priority is to restore public confidence in FDA oversight of drug safety and quality.