Pharmaceutical Technology Editors

Barr Pharmaceuticals,Inc.; Cardinal Health; GlaxoSmithKline

MedImmune, Inc. has broken ground on an expansion to its biologics manufacturing facility in Frederick, Maryland. The $250-million expansion is the first phase of a multi-phase construction project that MedImmune announced last fall.

Arlington, VA (Sept. 12)-At the American Association of Pharmaceutical Scientists meeting here, &quote;Real World Applications of PAT and QbD in Drug Process Development and Approval" (Sept. 11-12), chemical engineer and process modeler Michael L. Thompson, PhD, described how Procter & Gamble (West Chester, OH, www.pg.com) applies these mathematical tools to increase product quality and reduce development and trouble-shooting time for consumer and pharmaceutical products.

Scientists from GlycoFi, Inc., a wholly owned subsidiary of Merck & Co, in collaboration with Dartmouth-Hitchcock Medical Center, have engineered yeast cells capable of producing a broad range of recombinant therapeutic proteins with fully human sugar structures (glycosylation).

Genzyme Corporation, Luitpold Pharmaceuticals, Kemwell Pvt. Ltd.

US District Court Judge Robert Junell issued a written opinion in Medical Center Pharmacy, et al. v. Gonzalez, et al., supporting the ten plaintiff pharmacies? assertion that the US Food and Drug Administration lacks the authority to regulate compounded drugs and inspect state-licensed retail pharmacies.

Washington, DC (Sept. 1) - In a Federal Register announcement the US Food and Drug Administration laid out its guidance agenda for the coming months.

Arthur R. Mlodozeniec, PhD, a member of Pharmaceutical Technology's advisory board and past president of AAPS, died on Sept. 4.

FDA will strengthen its collaborative relationships with federal agencies participating in the National Nanotechnology Initiative.

Cardinal Health halted production, sales, repairs, and installations of its "Alaris Signature Edition Gold" infusion pump after the US Food and Drug Administration (Rockville, MD) seized approximately 1300 units last Friday. The seized infusion pumps (model numbers 7130, 7131, 7230, and 7231) have a "key bounce" defect that may cause overinfusion of medications by more than 10 times the intended infusion rate.

Hemispherx Biopharma, Inc., Boehringer Ingelheim Chemicals, Inc., MedImmune, Inc.

Biovail Corporation is demanding that the US Food and Drug Administration (Rockville, MD) enforce the proper criteria for determining bioequivalence of extended-release generic versions of bupropion products.

West Point, PA (Jul. 31)?A survey of 150 US pharmacists found that nearly 80% believe that "multiple look-alike medications" make it difficult for consumers to identify the correct medication, especially when the drugs are moved to unlabeled containers.

The International Organization for Standardization (ISO, www.iso.org) has formally issued and published standard ISO 4644-8:2006, Cleanrooms and associated controlled environments-Part 8: Classification of airborne molecular contamination. The document covers the classification of airborne molecular contamination (AMC) in cleanrooms and associated controlled environments in terms of airborne concentrations of specific chemical substances (individual, group, or category) and provides a protocol to include test methods, analysis, and time-weighted factors within the specification for classification.

Air Products, Althea Technologies, Inc., Bradley Pharmaceuticals, Bristol-Myers Squibb, Crucell N.V., Emergent Biosolutions

IBM Corporation (www.ibm.com) has combined radio-frequency identification (RFID) software, technology, and services to develop a track-and-trace system for pharmaceutical products.

Auriga, Balchem, Generex, ImClone, Intranasal Therapeutics, MedImmune, Schering

The US Food and Drug Administration's New Jersey District Office issued a Warning Letter to Concord Laboratories (Fairfield, NJ), citing the company for manufacturing three generic products without an ANDA, and for ten deviations from current good manufacturing practices.

ZymoGenetics (Seattle, WA) has sued Bristol-Myers Squibb (New York, NY) over alleged infringement of ZymoGentics's fusion-protein technology patents.

The US Food and Drug Administration (Rockville, MD) has sent warning letters to RoTech Healthcare, Inc. (Orlando, FL), CCS Medical (Clearwater, FL), and Reliant Pharmacy Services (Clearwater, FL), demanding that they stop manufacturing and distributing compounded, unapproved respiratory drugs.

North Carolina State University (Raleigh, NC) at the end of July celebrated the completion of the steel skeleton of its new Biomanufacturing Training and Education Center (BTEC, Raleigh, NC) with a topping-out ceremony attended by the construction workers and leaders from BioNetwork, BTEC, and the NC State Facilities Division.

AstraZeneca, Cambrex, Celsis, Cipher, Dimensione Ricerca

On Oct. 10, the US Food and Drug Administration (Rockville, MD) will hold a public meeting on products containing nanotechnology materials.

The Shenzhen government is planning to build a new national biopharmaceutical park in the Shenzhen Grand Industrial Zone.

The US Food and Drug Administration has published a draft guidance, Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC).

Aegis Therapeutics (San Diego, CA) has launched a new formulation technology to increase the stability of proteins and peptides.

Adams Respiratory Therapeutics, Inc.

Schering AG (Berlin, Germany) voluntarily issued a worldwide recall of all lots of its X-ray contrast agent "Ultravist Injection" 370 mgI/mL (iopromide injection) because particulate matter and crystallization may be present in the product.

The US Food and Drug Administration announced its Prescription Drug User Fee Amendments of 2002 (PDUFA II) fees schedule for fiscal year 2007 (Oct. 1, 2006 - Sept. 30, 2007), including increases ranging from 17% to 19%.

Ranbaxy issued three responses (March 20, April 20, May 25) to FDA's Form 483.