BioPharm International-11-01-2015

This case study reviews how quality-by-design principles can be implemented in an intermediate chromatography purification step that uses cation-exchange chromatography.Abstract

Troubleshooting

November 01, 2015

Whether taking an upstream, downstream or holistic approach, there are many factors to consider when choosing viral clearance methods.

Two experts discuss best practices to achieve acceptable sterility assurance levels for aseptically filled products.

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.

Perspectives on Outsourcing

November 01, 2015

Better process development is creating industry benchmarks for bioprocessing.

Regulatory Beat

November 01, 2015

New program emphasizes quality, risk, and global collaboration.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to ensure archive records can be retrieved.

From the Editor

November 01, 2015

Biopharma and contract providers must tread carefully amid changing market dynamics.

Features

November 01, 2015

The authors discuss performing investigations of biological products.

Features

November 01, 2015

Virtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.

Downstream Processing

November 01, 2015

Industry experts discuss the development of process chromatography in bioprocessing.

The authors present a review of the techniques commonly used for glycosylation analysis.

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