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Scalability of the Mobius CellReady Single-use Bioreactor Systems

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Review the process-design space and scalability of a single-use, stirred-tank bioreactor.

Custom-Cell Products: Diversified In Vitro Models

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The author outlines the need for custom-cell products.

Translating Stem Cells From Laboratory to Clinic

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Ontario-area scientists discuss approaches to development of stem-cell therapies.

Analytical Method Lifecycle: A Roadmap for Biopharmaceutical Development

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The authors propose a roadmap for analytical lifecycle development.

Increasing Lyophilization Productivity, Flexibility, and Reliability Using Liquid Nitrogen Refrigeration–Part 1 of 2

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Protein Therapeutics and the Regulation of Quality: A Brief History

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Regulatory agencies have evolved along with the biotechnology industry to define quality standards.

Plasmid DNA–Based Vaccines: Combating Infectious Diseases

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Like the egg-based vaccine production process, producing a vaccine under cGMP conditions using mammalian cells can be a lengthy process, taking a minimum of six to 12 months.

Pandemic Flu Preparedness: A Manufacturing Perspective

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For pandemic vaccine processing, single-use filter cartridges and membrane chromatography technologies could offer significant time- and cost-reduction advantages.

Regulatory Issues: Pandemic Preparedness Pacing Up

August 2, 2007

Any endpoint considered appropriate to support approval, whether a surrogate or a clinical endpoint, must be supported by substantial evidence of effectiveness.

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