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Facility Design

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.

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.

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.

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.

New Manufacturing Facilities Announced

May 23, 2007

Eden Biodesign (Liverpool, UK, www.edenbiodesign.com), SAFC (St. Louis, MO, www.sigmaaldrich.com/SAFC/Pharma), Midatech Group (Oxfordshire, OX, www.midatechgroup.com), Cellexus Systems (Cambridgeshire, UK, www.cellexusbiosystems.com), and BioConvergence LLC (Bloomington, IN, www.bioc.us) are sprucing up their product development and services with the construction of new manufacturing facilities.

Singapore Burgeoning with New Biotech Facilities

April 22, 2007

Singapore's efforts to grow its biologics manufacturing sector received a significant boost on March 28, 2007, when the Singapore Economic Development Board (EDB) announced that Genentech, Inc. (San Francisco, CA, www.gene.com) has decided to establish a commercial-scale microbial-based biologics manufacturing facility in Singapore.

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