Articles on chromatography, filtration, scale-up for proteins, MAbs, vaccines - BioPharm International

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Downstream Processing
The separation and purification steps of biotech processing, including chromatography and filtration. Vaccine and monoclonal antibody (MAb) manufacturing are also found here.

A Renaissance in Biomanufacturing: The Art of Purification

August 2, 2013

The industry needs to embrace innovation to improve the efficiency and robustness of biopharmaceutical purification without driving up the cost of goods.

Applying Continuous-Flow Pasteurization and Sterilization Processes

August 1, 2013

The author discusses HTST pasteurization and UHT sterilization.

Clearing Viral Concerns in Animal-Derived Biomaterials

August 1, 2013

Viruses in animal-derived starting materials could contaminate biopharmaceutical final product. A rigorous testing strategy and removal methods are reviewed.

Focusing on Quality for Parenteral Drug Manufacturing

July 23, 2013

Susan Schniepp, vice-president of quality and regulatory affairs at Allergy Laboratories and co-chair of the program planning committee for the 2013 PDA/FDA Joint Regulatory Conference, discusses quality systems and related considerations in parenteral drug manufacturing.

QbD and PAT in Upstream and Downstream Processing

July 1, 2013

Industry experts discuss the implementation of QbD and PAT tools in biopharmaceutical manufacturing.

Aggregation of Monoclonal Antibody Products: Formation and Removal

March 1, 2013

Aggregate formation is influenced by multiple aspects of the bioproduction process but can be mitigated by good process design and control.

Polishing Complex Therapeutic Proteins

January 1, 2013

A new downstream purification platform using a salt-tolerant membrane adsorber.

The Future of Biopharma

January 1, 2013

What the industry's future holds and what needs to be done to get there.

A New Scale-Down Membrane Adsorber Device for Process Development and Validation

December 1, 2012

The authors describe the development of an ultra scale-down anion exchange membrane adsorber, and demonstrate scalability to larger-scale devices.

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