Facility Design - BioPharm International

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Facility Design

Standardized, Hands-on Biomanufacturing Training is Essential

January 1, 2009

The development of a skilled labor force is essential for an expanding biopharmaceutical industry.

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.

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.

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.

Bristol-Myers Squibb to Acquire Adnexus Therapeutics

October 9, 2007

Bristol-Myers Squibb (Princeton, NJ) will acquire privately held Adnexus Therapeutics (Waltham, MA), the developer of a new therapeutic class of biologics called Adnectins.

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