Feature Articles - BioPharm International

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Feature Articles

Single-Use Bioreactors for the Rapid Productionof Preclinical and Clinical Biopharmaceuticals

October 1, 2014

Fed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.

Challenges and Trends in Biopharma Facility Design

September 1, 2014

Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design

Managing Cleaning Validation in Multi-Product Biologics Facilities

September 1, 2014

Developing and maintaining a current master plan for cleaning in multi-product facilities are crucial.

Evaluating Design Margin, Edge of Failure, and Process Capability

September 1, 2014

Design space generation is encouraged in new product development.

Assessing a Risk Management Program

September 1, 2014

Program review can help quality risk management live up to the promise of ICH Q9.

Challenges of Protein Aggregation during Purification

September 1, 2014

Careful selection of downstream processing conditions is a must.

Optimizing Human Performance, Part II: A Road Worth Traveling

August 1, 2014

Part II of this three-part series presents a roadmap to human error prevention.

Stirring the Mix of Single-Use Mixers

August 1, 2014

Single-use products offer options and choices for biopharma mixing.

Ensuring the Safety, Quality, and Identity of Biopharmaceutical Raw Materials

August 1, 2014

Going beyond pharmacopeial requirements is essential for the quality and safety of raw materials.

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