Feature Articles - BioPharm International

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Feature Articles

Concentrating Feed—an Applicable Approach to Improve Antibody Production

June 1, 2014

Different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture are evaluated.

Assuring Equivalency of Alternative Lot-Release Test Methods

June 1, 2014

New test methods can provide improved quality and efficiency, but they must be validated to demonstrate equivalency.

Biopharma Moves to Integrated, Single-Use, Downstream Processing

June 1, 2014

Suppliers see challenges to the adoption of single-use technologies for downstream processing as opportunities.

Challenges in Analytical Method Development and Validation

June 1, 2014

Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.

Weighing Clinical Trial Outsourcing Options

May 28, 2014

Evolving clinical trial research services give biopharmaceutical companies options for full- and functional-services.

Accelerated Stability Modeling

May 1, 2014

Characterization of stability performance provides a clear, statistically defendable method for determining accelerated stability.

Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions

May 1, 2014

New approaches to vaccine production are targeting rapid supply for pandemic situations and broadly effective therapeutic treatments.

Standardizing Practices for Disposables

May 1, 2014

Progress is being made in the development of harmonized best practices for single-use systems.

Regulatory Requirements for Viral-Challenge Studies: Influenza Case Study

May 1, 2014

Review regulatory requirements and the use of viral-challenge studies in drug development.

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