BioPharm International, October 2014 - BioPharm International

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BioPharm International, October 2014
Cover Story
Challenges in Biologic Drug and Vaccine Delivery
By Cynthia Challener, PhD
Prefilled syringes offer advantages to manufacturers, healthcare professionals, and patients.
Special Section
Continued Process Verification for Biopharma Manufacturing
By Jeff Fleming , Robin Payne
The authors discuss complications of implementing continued process verification and provide recommended approaches.
Application of Quality by Design to Viral Safety
A quality-by-design approach that defines potential viral contaminants of source materials can be used to achieve viral clearance.
Peer-Reviewed Research
Single-Use Bioreactors for the Rapid Productionof Preclinical and Clinical Biopharmaceuticals
By Rüdiger Heidemann, PhD , Christopher R. Cruz , Paul Wu, PhD , Mikal Sherman , Jessica Martin , Christel Fenge, PhD
Fed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.
Troubleshooting
Coupling Light Scattering with Size-Exclusion Chromatography
By Cynthia Challener, PhD
Adding light scattering to size-exclusion chromatography (SEC) can maximize the benefits of SEC.
Manufacturing Best Practices
Continuous Improvement in Biopharma Manufacturing
By Simon Chalk
Unexpected problems can become opportunities to share knowledge and improve processes.
Regulatory Beat
Biopharma Manufacturers Respond to Ebola Crisis
By Jill Wechsler
Demand for new therapies and vaccines spotlights production challenges.
Perspectives on Outsourcing
CMO Industry Thins Out
By Jim Miller
The trend of exits from the CMO industry looks to be gaining momentum.
Guest Editorial
Bolstering Graduate Education and Research Programs
By Marilyn E. Morris
AAPS supports graduate-level programs impacted by cutbacks in funding and resources.
Products
Disposable Filtration Device Improves Bioburden Testing
The EZ-Fit Filtration Unit, a ready-to-use, disposable filtration device for bioburden testing from EMD Millipore, the Life Science division of Merck KGaA, increases reliability and streamlines workflows.

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