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Aligning Manufacturing and Business Strategies with Single-Use Systems

November 2, 2012

The authors explain why Catalent decided to transition from stainless steel to single-use systems.

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.

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.

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.

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.

Key Considerations in Biosimilars Development

October 1, 2012

Understanding opportunities and challenges across all major phases of development.

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.

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