Feature Articles - BioPharm International

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Feature Articles

Ensuring a Robust Raw-Materials Supply Chain

July 1, 2014

With globalization, biopharmaceutical companies must establish strategies to minimize vulnerabilities in the raw-materials supply chain.

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.

Analyzing Proteins Using SEC, MALS, and UHPLC

July 1, 2014

Light scattering analysis combined with more rapid size exclusion chromatography improves protein characterization.

Brazil's Phytotherapic Drug Market and Regulation

July 1, 2014

Is there potential for growth in Brazil's phytotherapic drug market?

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.

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.

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.

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.

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