Feature Articles - BioPharm International

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Feature Articles

Optimizing Human Performance: Part I

July 1, 2014

Achieving excellence in human performance is an achievable system of cultivating and sustaining exceptional levels of performance.

Defining Critical Quality Attributes for mAb Therapeutic Products

July 1, 2014

Establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.

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.

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.

Control Strategies for Synthetic Therapeutic Peptide APIs Part III: Manufacturing Process Considerations

June 1, 2014

USP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs.

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.

Brunei's Potential Pharmaceutical Market Growth

June 1, 2014

Brunei harnesses its rich biodiversity and the growing halal market in a bid to develop its pharmaceutical sector.

Weighing Clinical Trial Outsourcing Options

May 28, 2014

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

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