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EU Raises API Standards: A Curse in Disguise?

September 1, 2013

The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?

Growth Kinetics of Human Mesenchymal Stem Cells in a 3-L Single-Use, Stirred-Tank Bioreactor

April 1, 2013

The authors describe the growth characteristics of human mesenchymal stem cells cultured in a stirred-tank bioreactor.

Achieving More Effective and Efficient GMP Auditing

March 2, 2013

The authors present solutions based on a review of current service offerings and their audit experience.

Aggregation of Monoclonal Antibody Products: Formation and Removal

March 1, 2013

Aggregate formation is influenced by multiple aspects of the bioproduction process but can be mitigated by good process design and control.

Standards-Setting Activities on Impurities

March 1, 2013

USP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.

Therapeutic Antibodies in Review

February 1, 2013

Innovative products and a range of indications drive the therapeutic antibody market.

Biologics: What Does the Future Hold?

January 1, 2013

Neil Lewis, chief technology officer at Malvern Instruments, talks about the challenges associated with biologics.

Navigating Emerging Markets

December 1, 2012

An introduction to a new series on manufacturing within global markets.

Compressing Drug Development Timelines with Accelerated Immunoassay

August 1, 2012

Recently developed immunoassay technology platforms reduce sample volume requirements and improve cycle times.

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