May 2018
Volume 31, No. 5 |
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| COVER STORY |
Cynthia A. Challener
More published data and regulatory approvals are needed to drive adoption of continuous bio-manufacturing.
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| DOWNSTREAM PROCESSING |
Rita C. Peters
Process understanding and careful assessment of risks are essential in developing viral clearance programs.
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| PEER-REVIEWED |
Kenneth D. Cole, Paul DeRose, Hua-Jun He, Erica V. Stein, Brian Lang, John Schiel, Aaron Urbas, Evelyn Solis, Steve Choquette
The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.
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| BioPharm International May Issue
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| QUALITY |
Russell E. Madsen
A validation plan developed to support a process unrelated to biopharmaceutical manufacture is applied to biopharmaceutical processes and systems.
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| PROCESS MONITORING |
Agnes Shanley
The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and downstream applications.
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| FROM THE EDITOR |
Rita C. Peters
While technology promises advances for healthcare, a skilled workforce is needed to deliver on the potential.
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| REGULATORY BEAT |
Jill Wechsler
FDA's commissioner addresses opioid abuse, drug costs, and manufacturing quality.
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| PERSPECTIVES ON OUTSOURCING |
Jim Miller
CDMOs can claim credit for the robust growth of emerging bio/pharma financings.
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| ASK THE EXPERT |
Siegfried Schmitt
Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.
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| EVENTS |
June 4–7, 2018
June 7–8, 2018
June 14–15, 2018
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