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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.

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.

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.

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.

Considerations for Scale-Up of Stem-Cell Cultures

November 1, 2012

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

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.

Key Considerations in Biosimilars Development

October 1, 2012

Understanding opportunities and challenges across all major phases of development.

Correlating Product Lifecycle and Manufacturing Site Characteristics with Product Deviations

October 1, 2012

MIT survey results address product and site characteristics that statistically correlate with quality performance.

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