Whitepapers - BioPharm International

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Whitepapers

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.

Validation Week Conference Brochure

September 24, 2013

Validation Week Conference Brochure

Improving Aggregate Removal from Monoclonal Antibody Feed Using High Resolution Cation Exchange Chromatography

August 27, 2013

Nuvia™ HR-S media is a new cation exchanger designed for high resolution of closely related product impurities such as aggregates. It delivers excellent resolution with a final aggregate content of < 0.3% and a high recovery of > 80% from a heterogeneous feed of monoclonal antibody aggregates and monomer. Aggregate content and recovery in the eluate were shown to be a function of the target conductivity measured at the end of collection

Purification of Recombinant Proteins: A Simple Approach to Method Development

June 25, 2013

Using a simple DOE exercise, the authors demonstrate how to elucidate the nature and degree of interaction between various proteins and the binding ligand for Nuvia™ cPrime™ Hydrophobic Cation Exchange Media, thus allowing method developers to quickly and effectively optimize selectivity and define design space parameters.

High-resolution Analysis of Charge Heterogeneity in Monoclonal Antibodies Using pH-gradient Cation Exchange Chromatography

June 25, 2013

The authors describe pH-based separation of acidic and basic charge variants for mAbs using the Agilent 1260 Infinity Bio-inert Quaternary LC System and an Agilent BioMAb PEEK 4.6 x 250 mm IEX column, featuring a special particle coating designed for charge-based separation of MAbs.

Cookie Cutter Proteolysis: Achieving Reproducible, Efficient Digestions for Proteomic Workflows

August 27, 2013

Recently, an automated protein digestion platform was developed which accelerates the digestion process while providing exceptional reproducibility. As demonstrated here, it offers complete, reproducible protein digestions in as little as 30 seconds, allowing hundreds of samples to be run per day, and can be adapted to many applications.

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