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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.

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.

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.

Considerations for Scale-Up of Stem-Cell Cultures

November 1, 2012

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

Vaccine Packaging at the Clinical Interface of Vaccine, Healthcare Worker, and Patient

October 1, 2012

Packaging vaccines using prefilled syringes can increase dosing efficiency, reduce costs, and improve patient safety. This article is part of a special section on vaccines.

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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