Facility Design - BioPharm International


Facility Design

Bayer Acquires Biologics Manufacturing Facility, Rights from Novartis

October 9, 2007

Bayer Schering Pharma AG, (Berlin, Germany) has completed the acquisition of a biologics manufacturing facility in Emeryville, CA, from Novartis.

SAFC Expands Fermentation Capabilities with Upgrade of Israel Site

October 9, 2007

SAFC (St. Louis, MO), a member of the Sigma-Aldrich Group, has announced a $29-million investment to significantly expand its drug substance capabilities in high-potency biologics at the Sigma-Aldrich facility in Jerusalem, Israel

On the Biotechnology Frontier: Personalized Medicine, A Discussion with E.J. Brandreth

October 1, 2007

Favrille, a San Diego-based biopharmaceutical company, is one of a handful of firms on the forefront of personalized medicine. Because personalized treatment is tailored to an individual's biology, it has the potential to be far more effective than current approaches to disease management.

Final Word: In the Quest to Manage Capacity, Biology Trumps Stainless Steel

September 1, 2007

From the earliest days of the biotechnology industry, companies have grappled with the complexities of making innovative biopharmaceuticals on a large scale. Success in manufacturing begins with process science, since biotech production requires perfection in maintaining living organisms in a sterile environment under controlled physiological conditions. But unless companies can solve the challenge of planning for and managing manufacturing capacity, they will not be able to achieve the full potential of promising biotech products.

Final Word: The Case for Flexible Manufacturing Capacity

August 1, 2007

The mounting threats of pandemic influenza, bioterrorism, and emerging infectious diseases continue to be the focus of research programs and funding initiatives, not only within governmental agencies, but also universities, private research firms, and commercial manufacturing entities. With all of these efforts, however, the question of manufacturing capacity and the ability to respond to pandemic and emerging threats continues to be a major concern.

Roche Opens New Biotechnology Production Center in Switzerland

June 21, 2007

Roche (Basel, Switzerland, www.roche.com) has opened its new biotechnology production center in Basel.

Expanded FluMist Indication Delayed by cGMP Violations

June 21, 2007

The FDA issued MedImmune, Inc. (Gaithersburg, MD, www.medimmune.com), a warning letter for violating the agency's manufacturing rules and held off approving the company's influenza vaccine for use in children younger than age five until the problems are resolved.

IBPL Becomes India's First EU-GMP Certified Biopharmaceutical Facility

June 21, 2007

Intas Biopharmaceuticals Limited (IBPL, Gujarat, India, www.intasbiopharma.co.in) has become India's first dedicated biopharmaceutical company to receive certification from the European Agency for the Evaluation of Medicinal Products (EMEA, London, UK, www.emea.europa.eu) or an EU-GMP certification for its manufacturing facility at Ahmedabad, Gujarat.

Facility Design: Simulation Methodology for Facility Design

June 1, 2007

Discrete simulation allows the design teams to see every meaningful detail about equipment and materials flowing through the process.



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