Article - BioPharm International



Scalability of the Mobius CellReady Single-use Bioreactor Systems

April 2, 2013

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

Custom-Cell Products: Diversified In Vitro Models

April 1, 2013

The author outlines the need for custom-cell products.

Translating Stem Cells From Laboratory to Clinic

April 1, 2013

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

Analytical Method Lifecycle: A Roadmap for Biopharmaceutical Development

April 1, 2013

The authors propose a roadmap for analytical lifecycle development.

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

November 1, 2007

Protein Therapeutics and the Regulation of Quality: A Brief History

October 1, 2007

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

Plasmid DNA–Based Vaccines: Combating Infectious Diseases

August 2, 2007

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

August 2, 2007

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.



Click here