Feature Articles - BioPharm International

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Feature Articles

Challenges in Biologic Drug and Vaccine Delivery

October 1, 2014

Prefilled syringes offer advantages to manufacturers, healthcare professionals, and patients.

Application of Quality by Design to Viral Safety

October 1, 2014

A quality-by-design approach that defines potential viral contaminants of source materials can be used to achieve viral clearance.

Continued Process Verification for Biopharma Manufacturing

October 1, 2014

The authors discuss complications of implementing continued process verification and provide recommended approaches.

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.

Coupling Light Scattering with Size-Exclusion Chromatography

October 1, 2014

Adding light scattering to size-exclusion chromatography (SEC) can maximize the benefits of SEC.

Evaluating Design Margin, Edge of Failure, and Process Capability

September 1, 2014

Design space generation is encouraged in new product development.

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.

Assessing a Risk Management Program

September 1, 2014

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

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