BioPharm International
December 01, 2017
Regulatory Beat
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New gene therapies and combination products require innovative regulatory approaches.
December 01, 2017
Perspectives on Outsourcing
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In a productive year, 2017 was filled with acquisitions, facility expansions, and new biopharma technology.
December 01, 2017
Ask the Expert
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SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
December 01, 2017
Cover Story
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Biopharma employees reveal employment objectives, opportunities, and frustrations.
December 01, 2017
Features
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Single-use systems provide replaceable fluid paths.
December 01, 2017
From the Editor
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Developing and retaining qualified employees will test biopharma companies and CMOs alike.
December 01, 2017
Features
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A technology roadmap aims to drive and consolidate improvements in a process that has remained unchanged for more than 70 years.
December 01, 2017
Features
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A quality-by-design approach that implements PAT offers advantages in upstream cell-culture processing.
December 01, 2017
Features
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A roundtable Q&A with biopharma executives elucidates the challenges posed by single-use bioreactor bags in contributing to extractables and leachables in the biomanufacturing process.
December 01, 2017
Features
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The Biomanufacturing Technology Roadmap is accelerating innovative manufacturing strategies for biopharmaceuticals.
December 01, 2017
Features
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Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.
December 01, 2017
Features
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Small-molecule therapeutics can also benefit from the implementation of PAT in the manufacturing process.
December 01, 2017
Issue PDF
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Click the title above to open the BioPharm International December 2017 issue in an interactive PDF format.