BioPharm International
December 01, 2015
Downstream Processing
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Subjective visual evaluation of freeze-dried products can be quantified through mechanical methods of characterizing the properties these materials.
December 01, 2015
Downstream Processing
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BioPharm International sat down with Kevin Isett, PhD, co-founder and CEO of Avitide, to find out why he thinks the company’s tailored approach to purification resins will change the face of biopharmaceutical separation.
December 01, 2015
Upstream Processing
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Use of a subspace model is a viable method to characterize process space variables and optimize process performance.
December 01, 2015
Peer-Reviewed Research
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The authors evaluate the SoloVPE technique as a replacement for nitrogen-based protein determination.
December 01, 2015
Regulatory Beat
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12
FDA confirmed quality focus while Congress moved to bolster biomedical innovation.
December 01, 2015
Perspectives on Outsourcing
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CMO industry consolidation may be frustrated by a dearth of attractive assets.
December 01, 2015
Quality
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Expectations are high for rapid testing methods, but demonstration of comparability proves challenging.
December 01, 2015
Features
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Advances in glycan analysis are enhancing biologics development and quality control processes.
December 01, 2015
From the Editor
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Biopharma employees in different market segments note subtle differences in job satisfaction.
December 01, 2015
Regulatory Beat
28
12
Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
December 01, 2015
Cover Story
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12
Limited career and salary growth complicate a somewhat positive employment picture.
December 01, 2015
Issue PDF
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Click the title above to open the BioPharm International December 2015 issue in an interactive PDF format.