Monoclonal Antibody (MAb) Manufacturing Articles - BioPharm International

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Monoclonal Antibody (MAb) Manufacturing Articles

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.

Monoclonal Antibodies Key to Unlocking the Biosimilars Market

April 1, 2014

The approval and acceptance of monoclonal antibody biosimilars is necessary if the biosimilars market is to experience real growth.

Comparing Protein A Resins for Monoclonal Antibody Purification

December 1, 2013

A prototype Protein A resin is evaluated for purification performance, reusability, and cost performance.

Evolution of the Monoclonal Antibody Purification Platform

November 1, 2013

The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.

Systematic Approaches to Develop Chemically Defined Cell Culture Feed Media

November 1, 2010

Making chemically defined media work.

Designing in Quality: Approaches to Defining the Design Space for a Monoclonal Antibody Process

May 1, 2010

How to use risk assessment strategies to integrate operations.

Developing a MAb Aggregate Removal Step by High Throughput Process Development

April 1, 2010

HTPD allows rapid screening of chromatographic parameters.

Advances in Monoclonal Antibody Purification

March 2, 2010

New technologies and adaptations of existing technologies can improve platform processes.

PEG Precipitation: A Powerful Tool for Monoclonal Antibody Purification

March 2, 2010

This alternative purification method to chromatography is readily scalable and fits a fully disposable downstream process.

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