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.

Trends in Downstream Bioprocessing

September 1, 2013

While the severity of capacity problems related to downstream processing appears to have eased, it continues to be a problem and chromatography columns are the most frequent culprits.

Identification and Quantification of Trace-Level Protein Impurities

September 1, 2013

A simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics is described.

Protein Purification Using Single-Use Technology

August 2, 2013

Uwe Gottschalk, vice-president of purification technologies, Sartorius Stedim Biotech, discusses specific challenges in protein purification.

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.

The Future of Downstream Processing-2013

August 2, 2013

As constant scale up grows out of favor in the biopharmaceutical industry, new—and old—approaches are required. The author reviews the state of downstream processing and considers potential solutions, including the streamlining of full processes and borrowed technologies

Virus Filtration Using a High-Throughput Parvovirus-Retentive Membrane

August 2, 2013

Test procedures for a surface-modified polyethersulfone hollow-fiber filter.

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.

Applying Continuous-Flow Pasteurization and Sterilization Processes

August 1, 2013

The author discusses HTST pasteurization and UHT sterilization.

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.

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