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.

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.

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.

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.

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.

Progress in the Prediction of Protein Aggregation

January 1, 2014

Techniques to enable the design and formulation of stable, protein-based therapeutics.

2014 Manufacturing Trends and Outlook

January 1, 2014

Single-use systems and other technologies drive process efficiencies, but there is room for improvement.

Comparing Protein A Resins for Monoclonal Antibody Purification

December 1, 2013

A prototype Protein A resin is evaluated for purification performance, reusability, and cost performance.

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