Whitepapers - BioPharm International



Minimizing the risk of mycoplasma contamination

September 1, 2012

Mycoplasma contamination can have a major harmful impact on the biopharmaceutical manufacturer. This application note discusses how 0.1 micron filtration can protect cell culture media from mycoplasma contamination without significantly slowing down processing.

Sanitization of a Process Chromatography Column

September 1, 2012

Process Chromatography columns must provide a very high level of cleanability to meet the requirements of various regulatory agencies. This study details the sanitary design and cleaning procedure of the Bio-Rad InPlace column.

Managing Cell-Based Potency Assays – from Development to Lifecycle Maintenance

June 1, 2012

Characterization of a biological product, which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities, is necessary to establish the safety and efficacy profile of a given product (ICH Q6B).

Quantitative Aspects of UPLC Peptide Mapping

July 23, 2007

Throughout the development of a biopharmaceutical protein, peptide mapping is used to demonstrate genetic stability and to confirm the intergrity of the protein. This whitepaper focuses on the quantitative aspects of UPLC peptide mapping with UV detection.

HarvestClearTM Filtration System for harvest of small-scale bioreactors

May 1, 2013

The clarification of batch and fed-batch bioreactor systems can pose a practical challenge to biopharmaceutical manufacturers due to high cell densities. The HarvestClearTM Filtration System is an automated single-use system designed to optimize clarification of 1L to 20L high density bioreactor outputs, while reducing hands-on time and increasing operator safety.



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