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.

Development of Robust Charge Heterogeneity Assays using DOE

August 27, 2013

Develop robust charge heterogeneity assays using Design of Experiment (DOE). Utilizing imaged cIEF and DOE provides efficient and rapid method development and reduces assay failure. This application note provides a step-by-step process for the successful application of DOE tools with the iCE3.

Biopharma Moves to Integrated, Single-Use, Downstream Processing

June 1, 2014

Suppliers see challenges to the adoption of single-use technologies for downstream processing as opportunities.

A Sampling of New Tools for Downstream Processing

June 1, 2014

Industry suppliers describe new technologies to facilitate downstream processing.

Raw Material Variability

April 1, 2014

The biopharmaceutical industry is developing a new approach to controlling variability in raw materials.

Single-Use Technology for Syringe Filling

March 1, 2014

A novel approach to sterile drug product manufacturing that uses a single-use assembly in a multi-product final filling suite with isolator technology offers benefits of efficiency and flexibility.

Single-Use Technology in Downstream Processing

March 1, 2014

Experts discuss the advances in single-use technology for downstream bioprocessing applications.

Predicting Lyophilization Performance

March 1, 2014

Researchers are using current understanding of the lyophilization process to predict performance on many levels during both process development and manufacturing.

Tackling the Challenge of Higher-Order Structure Determination

February 1, 2014

Advances in instrumentation, software, and methodologies provide more information than ever on the higher-order structure of proteins.

Advances in UPLC Techniques and Column Chemistry Aid the Confirmation of Biosimilarity

February 1, 2014

Automated sample handling, advanced glycan analysis and specially designed columns are helping biosimilar manufacturers speed up confirmation of the biosimilarity of their products.

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