Monoclonal Antibody (MAb) Manufacturing Articles - BioPharm International


Monoclonal Antibody (MAb) Manufacturing Articles

EMA: Extrapolation Across Indications for Biosimilars a Possibility

October 30, 2014

The final guidance explains some principles for developing biosimilars and establishes some rules about extrapolation across indications for various medical conditions.

Celgene and Sutro Partner on ADC Development

October 24, 2014

Celgene expands its oncology drug discovery and development portfolio through a new partnership with Sutro.

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.



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