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Upstream, Downstream Processing in Motion

November 2, 2012

GE Healthcare Life Sciences' ReadyToProcess platform aims to streamline bioprocessing.

Assay Development and Method Validation Essentials

November 1, 2012

A 10-step systematic approach to analytical method development and validation can improve the quality of drug development.

Report from Turkey

November 1, 2012

The government of Turkey is drawing up a program in coordination with the pharmaceutical industry to create ways to make the country a regional production center for pharmaceuticals serving Europe, Central Asia, and the Middle East.

Evaluation of Single-Use Fluidized Bed Centrifuge System for Mammalian Cell Harvesting

November 1, 2012

This article discusses the evaluation of a novel single-use fluidized bed centrifuge for harvesting of antibodies.

EU Sets Guidelines for Biosimilar mAbs

November 1, 2012

The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on mAbs.

Considerations for Scale-Up of Stem-Cell Cultures

November 1, 2012

Scaling up stem-cell cultures requires careful consideration of the bioreactor design.

A Manufacturing-Capacity Sharing Model

October 1, 2012

The manufacturing capacity-sharing model between Merck and MedImmune ushers in a new paradigm of "co-opetition."

Report from India

October 1, 2012

India has enforced stricter patent laws compared to other countries. For a drug to be patentable in India, the invention has to be novel, inventive, and industrially applicable.

Considerations in Outsourced Vaccine Manufacturing

October 1, 2012

Marco Chacon of Paragon Bioservices discusses the challenges associated with outsourced vaccine manufacturing.

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