Feature Articles - BioPharm International

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Feature Articles

Performing a Protein Purity Analysis Comparability Study

October 1, 2013

A well-designed comparability study can demonstrate the performance and advantages that can be gained when adopting a new protocol.

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.

Elucidating Biosimilars Characterization

September 1, 2013

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

Trends in Downstream Bioprocessing

September 1, 2013

While the severity of capacity problems related to downstream processing appears to have eased, it continues to be a problem and chromatography columns are the most frequent culprits.

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.

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.

Making Connections: The Crucial Junctions in Single-use Systems

August 1, 2013

Choosing the right disposable components for your application.

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