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Facility Design

Disposable Technologies Implementation: Understanding and Managing Risks

December 1, 2008

In new disposables projects, it is critical that engineering, procurement, and operations groups work together early on to manage supply chain risk.

The Case for Outsourcing Biologics Process Development

December 1, 2008

Four reasons why outsourcing may be the best option, and key factors to consider when selecting a provider.

Biomanufacturing Capacity Quandary

November 1, 2008

There could be a serious glut of commercial scale mammalian cell culture capacity over the next five years. Then again, there could be a significant shortage. It all depends on how things develop in expression technology, the new product pipeline, and corporate strategies.

The Company at the Crossroads. Part 2: Build or Buy?

November 1, 2008

When making critical decisions such as whether to build or buy critical capabilities, companies need a decision-making approach that weighs risks and rewards as a science with adequate inputs, repeatable processes, and measurable results. The method must also accommodate the human factor by encouraging wide participation and providing the kind of neutral decision criteria that satisfies participants about the objectivity of the process.

Connecting the Manufacturing Process to Patient Wellness

August 1, 2008

Manufacturers of biopharmaceuticals can improve productivity by taking patient wellness into account.

PAREXEL Appoints Three New GMP Consultants for Europe

October 9, 2007

PAREXEL Consulting (Boston, MA) has hired three senior GMP consultants based in Europe with the hope of helping its clients address complexities of European Union directives in areas such as manufacturing regulations, quality, and safety.

Discovery Labs Sorts Out Manufacturing Issues, on Track for FDA Approval Letter

October 9, 2007

Discovery Laboratories (Warrington, PA) could see the end of its struggle to launch its Surfaxin (lucinactant) drug on the US market soon, as the manufacturing issues it has faced have been resolved.

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

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.

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