BioPharm International
August 01, 2015
Cover Story
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Industry experts spoke to BioPharm International about the key considerations in the development of a drug-delivery device for a biologic drug, the importance of human factors engineering, the advantages of prefilled syringes, and the challenges in the manufacture of these devices.
August 01, 2015
Downstream Processing
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Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.
August 01, 2015
Upstream Processing
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A thorough cell-bank testing plan is necessary to certify the safety and purity of a resulting biopharmaceutical product.
August 01, 2015
Peer-Reviewed Research
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The authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.
August 01, 2015
Troubleshooting
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Optimization of each phase in a chromatographic cycle has a positive impact on productivity.
August 01, 2015
Regulatory Beat
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FDA and industry support global framework and collaborations to secure the supply chain.
August 01, 2015
Perspectives on Outsourcing
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Biopharma companies are outsourcing more jobs to cut costs.
August 01, 2015
From the Editor
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FDA notes progress in drug development, but cites scientific and funding roadblocks.
August 01, 2015
Features
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This article discusses cleaning validation of equipment dedicated to the production of a single API.
August 01, 2015
Features
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Industry experts discuss challenges, trends, and innovations in fluid handling.
August 01, 2015
Issue PDF
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Click the title above to open the BioPharm International August 2015 issue in an interactive PDF format.
July 02, 2015
Compliance Notes
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Siegfried Schmitt, principal consultant, PAREXEL, discusses how to handle internal audit reports during inspections.