BioPharm International
November 02, 2015
Peer-Reviewed Research
28
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This case study reviews how quality-by-design principles can be implemented in an intermediate chromatography purification step that uses cation-exchange chromatography.Abstract
November 01, 2015
Troubleshooting
28
11
Whether taking an upstream, downstream or holistic approach, there are many factors to consider when choosing viral clearance methods.
November 01, 2015
Cover Story
28
11
Two experts discuss best practices to achieve acceptable sterility assurance levels for aseptically filled products.
November 01, 2015
Features
28
11
The global supply chain for bovine and porcine heparin and regulatory considerations are examined.
November 01, 2015
Perspectives on Outsourcing
28
11
Better process development is creating industry benchmarks for bioprocessing.
November 01, 2015
Regulatory Beat
28
11
New program emphasizes quality, risk, and global collaboration.
November 01, 2015
Compliance Notes
28
11
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to ensure archive records can be retrieved.
November 01, 2015
From the Editor
28
11
Biopharma and contract providers must tread carefully amid changing market dynamics.
November 01, 2015
Features
28
11
The authors discuss performing investigations of biological products.
November 01, 2015
Features
28
11
Virtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.
November 01, 2015
Downstream Processing
28
11
Industry experts discuss the development of process chromatography in bioprocessing.
November 01, 2015
Upstream Processing
28
11
The authors present a review of the techniques commonly used for glycosylation analysis.
November 01, 2015
Issue PDF
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