Monoclonal Antibody (MAb) Manufacturing Articles - BioPharm International


Monoclonal Antibody (MAb) Manufacturing Articles

Amgen Sues Sanofi and Regeneron over Patent for mAb Targeting PCSK9

October 20, 2014

A Priority Review voucher Sanofi and Regeneron purchased from BioMarin pharmaceuticals may put their mAb ahead of Amgen?s in the market.

Harnessing the Power of Modified T Cells to Treat Cancer

October 17, 2014

Personalized immunotherapy treatments help 90% of acute lymphoblastic leukemia patients achieve remission in a new study.

Single-Domain Antibodies for Brain Targeting

August 1, 2014

Single-domain antibodies are emerging as credible alternatives due to their target specificity, high affinity, and cost-effective recombinant production.

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.



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