Feature Articles - BioPharm International

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Feature Articles

Identification and Quantification of Trace-Level Protein Impurities

September 1, 2013

A simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics is described.

Elucidating Biosimilars Characterization

September 1, 2013

Review the importance of characterization studies during biosimilars development and related analytical methods.

Essentials in Establishing and Using Design Space

September 1, 2013

Knowledge of product or process acceptance criterion is crucial in design space.

Best Practices for Restricted Access Barrier Systems

September 1, 2013

Restricted access barrier systems (RABS) maximize product control but minimize operator interaction in aseptic manufacturing.

Gauging the Outlook of the Biologics Market

September 1, 2013

Mike Jenkins, general manager of Catalent Biologics discusses the evolving landscape of the biologics market and hurdles faced in the development and manufacture of these innovative products.

New Gene Patent Rules

August 1, 2013

The US Supreme Court's Myriad decision satisfied both patient groups and patent holders

Process Lifecycle Validation: Applying Risk Management

August 1, 2013

The authors discuss the application of risk management in process lifecycle validation, manufacturing, and change control.

Navigating Emerging Markets: South Korea

August 1, 2013

The bio-pharmaceutical business outlook in South Korea remains positive

Making Connections: The Crucial Junctions in Single-use Systems

August 1, 2013

Choosing the right disposable components for your application.

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