March 2007 - Pharmaceutical Technology

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March 2007

Pharmaceutical Technology


The rule will, however, impose new record-keeping requirements on some 1200 manufacturing establishments (including an estimated 674 pharma plants and 253 biotech facilities), which must show that their processes do not use the proscribed "Specified Risk Materials." These SRMs are defined as the brain, skull, eyes, trigeminal ganglia, spinal cord, most of the vertebral column, and dorsal root ganglia of cattle 30 months and older, and the tonsils and distal ileum of the small intestine of all cattle.

Manufacturers would be required under 21 CFR Sections 300.200(c)(1), 500.200(c)(1), 600.16(c)(1), 895.102 (c)(1), and 1271.470(c)(1) to maintain records that demonstrate that all cattle-derived materials conform to the prohibition. These could include signed and dated affirmations from slaughterhouses or renderers. The agency estimates the cost of compliance will be small, about $45 to $90 per year, depending on the size of the establishment.

The rule notes that cattle products may be used in manufacturing gelatin, heparin, surfactants, hormones, enzymes, glycosphingolipids, amino acids, glycerol, detergents, blood, collagen, fetal calf serum, bovine meat, and tallow and tallow derivatives.

BSE is a transmissible spongiform encephalopathy (TSE) thought to be caused by prions, for which no screening tests now exist. Human TSEs include Creutzfeld-Jakob Disease (CJD), variant Creutzfeld-Jakob Disease, Gerstmann-Straussler-Scheinker syndrome, kuru, fatal familial insomnia, and sporadic fatal insomnia. Nonhuman TSEs include, in addition to BSE in cattle, scrapie in sheep and goats, transmissible mink encephalopathy, feline spongiform encephalopathy, and chronic wasting disease (CWD) in deer and elk.

-Douglas McCormick

RESTRUCTURING

AstraZeneca Plans Production Rationalization and Job Cuts



London (Feb. 1)—AstraZeneca PLC ( http://www.astrazeneca.com/) unveiled a plan to improve asset utilization within its global supply chain that involves rationalizing production assets and cutting staff. The company made the announcement as part of its fourth-quarter and full-year 2006 financial results.

Over the next three years, AstraZeneca plans to rationalize production assets, anticipating accounting charges of roughly $500 million, and reduce its workforce by 3000, subject to consultations with work councils, trade unions, and other employee representatives and in accordance with local labor laws. The company did not disclose which particular facilities would be affected.

"Going forward, management remains committed to maintaining a competitive financial performance during a period when the company, as well as the industry, faces the challenges imposed by patent expirations and pricing pressures from the government and private-sector players," said the company in a prepared statement to explain the rationale for the cost reductions.

For 2006, AstraZeneca reported an 11% sales gain to $26.5 billion and a 28% gain in profit to $6.04 billion.

AstraZeneca acquires biotech company

In another move, AstraZeneca agreed to acquire Arrow Therapeutics Ltd. (London, http://www.arrowt.co.uk/), a privately held biotechnology company, for $150 million. Arrow Therapeutics is focused on the discovery and development of antiviral therapies. It has 57 employees at its facilities in London.

-Patricia Van Arnum

REGULATIONS/SAFETY

FDA Report Details Steps to Improve Safety Programs

Rockville, MD (Jan. 30)—In response to a set of recommendations from the Institute of Medicine (IOM, Washington, DC, http://www.iom.edu/), the US Food and Drug Administration ( http://www.fda. gov/) has issued a report detailing a series of initial steps to improve its safety programs.


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