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Advances in Animal-Free Manufacturing of Biopharmaceuticals

May 2, 2007

In addition to existing guidance, in January 2007 the FDA announced further proposals to prohibit the use of certain bovine materials as ingredients in some medical products or as elements of product manufacturing.

Applying Fusion Protein Technology to E. coli

May 2, 2007

Protein expression remains an arduous task that involves a complex decision tree. Establishing tools and optimal conditions for each protein remains an empirical exercise.

China Today: Intellectual Property Protection in China: Does it Warrant Worry?

May 1, 2007

China's central government is aware of the need to improve intellectual property protection and enforcement.

Separation & Purification: Endotoxin Reduction Using Disposable Membrane Adsorption Technology in cGMP Manufacturing

May 1, 2007

Membrane-based chromatography technologies sometimes offer advantages over resin-based technologies.

Regulatory Beat: Campaign Accelerates for Follow-on Biologics

May 1, 2007

The information provided by analytical testing is important in determining whether additional clinical trails are necessary to bring a follow-on to market.

From the Editor: Score One for Preparedness

May 1, 2007

Fortunately for all of us, not everyone's head is in the sand.

Outsourcing: Transition from Business Process Outsourcing to Knowledge Process Outsourcing

May 1, 2007

By outsourcing high-end processes that demand advanced analytical and technical skills, biopharm companies are reaping substantial savings.

Final Word: Political Will is the Backbone of Regulation Enforcement

May 1, 2007

Lax enforcement arising from a lack of political will creates the potential for a loss of public confidence.

Chromatography: A Two-Column Process To Purify Antibodies Without Protein A

May 1, 2007

This flexible setup minimizes the number of purification process steps, buffers, and process components.

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