Amy Ritter, PhD

FDA has released a final guidance describing cGMP for preparing media fills for validation of aseptic preparations for positron emission tomography (PET) drugs. Most PET drugs, which are used for imaging, are given parenterally, and produced by aseptic processing. PET drugs came under the auspices of FDA relatively recently, with the passage of the 1997 Food and Drug Administration Modernization Act, and minimum cGMP standards for this class of drugs were established in 2009. A guidance for preparing new drug applications and abbreviated new drug applications for PET drugs was issued in March 2011, and in comments to the March 2011 guidance and in questions raised at the public meeting, stakeholders requested that FDA provide guidance on media fills for validation of aseptic preparation for PET drugs. This most recent guidance is designed to help manufacturers of PET drugs comply with FDA regulations.

On Mar. 13, 2012, FDA issued a Warning Letter to Steven Victor, CEO of IntelliCell Biosciences for a violation of the Food, Drug, and Cosmetic Act (FD&C Act), and for violations of cGMP and Good Tissue Practice (GTP) in the manufacture of its adipose tissue-derived stem-cell product.

On Mar. 7, 2012, GE Healthcare announced an agreement to acquire Xcellerex, a supplier of manufacturing technologies for the biopharmaceutical industry, for an undisclosed amount.

Boehringer Ingelheim (BI) has announced in a press release the expansion of its biopharmaceutical manufacturing capabilities at its plants in Biberach, Germany and in Vienna, Austria.

Merck KGaA announced measures intended to reduce costs and increase efficiency to ensure the long-term success of its business model. The measures are part of a comprehensive transformation program that will be implemented in two phases. In the first two years, Merck plans to implement a new leadership organization, implement efficiency measures, and develop a long-term growth strategy. In the second phase, the company will explore new areas for growth. Cost savings from the first-phase efficiency measures are expected to fuel second-phase growth.

Because of the complexity of the manufacturing processes for biologics, transfer of these processes to a contract manufacturer presents challenges.

FDA has released a draft guidance for API manufacturers titled Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.

GlaxoSmithKline (GSK) released its fourth quarter and full year 2011 earnings report on Feb. 7, 2012. In the report, the company tracks its R&D performance, and calculated the return on R&D to be 12%, up from 11% in 2010, and closing in on the company’s goal of a 14% return.

The Pharmaceutical Research and Manufacturers of America (PhRMA) announced that it will transition the management of its benefit?risk action team (BRAT) to the Centre for Innovation in Regulatory Science (CIRS), according to a press release. CIRS is a neutral, independent UK-based subsidiary company, forming part of the Intellectual Property and Science business of Thomson Reuters. This transition is being made to further the program?s technical development and broaden input from the scientific community.

On Jan. 11, 2012, AstraZeneca and IMS Health announced a three-year collaboration to use real-world healthcare data from Europe to guide AstraZeneca?s discovery and clinical development programs.