October 2019
Volume 32, No. 10 |
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| COVER STORY |
Agnes Shanley
Used with perfusion, alternating tangential flow and tangential flow filtration are redefining upstream efficiency.
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| UPSTREAM PROCESSING |
Cynthia A. Challener
Leveraging automation and a step-by-step approach are keys to success.
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| DOWNSTREAM PROCESSING|
Robert Glaser
Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of
processes in the right direction.
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| BioPharm International October Issue
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| ANALYTICS |
Wendy Saffell-Clemmer and Elizabeth Joseph
The authors provide an introduction to aluminum adsorbed vaccines, review studies of antigen stability, and propose test methods for the analysis of aluminum vaccine release and stability analysis.
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| MANUFACTURING |
Hallie Forcinio
Advances in fill/finish for parenteral packaging address demands for efficiency and product safety.
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Biopharma N-Glycan Analysis Resource Center
An online resource with useful tools and practical information to find out more about Biopharma N-Glycan Analysis. The site provides useful webcasts, videos, application notes, posters, and more from leading practitioners in the field of chromatography.
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| BIOSIMILARS |
Agnes Shanley
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying risk to reduce costs.
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| DEVELOPMENT |
Noel D. Horton, Samuel S. Chuang, and Michael V. Templin
Learning to think with the end in mind will help clients and their selected CRO to design and conduct the right studies.
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| FROM THE EDITOR |
Rita C. Peters
Climbing out of a reputation hole can start with adopting a quality culture.
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| REGULATORY BEAT |
Jill Wechsler
Falsified documents and manipulated test results prompt warnings and investigations.
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| ASK THE EXPERT |
Susan J. Schniepp
Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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| EVENTS |
October 16, 2019
October 27 – November 1, 2019
November 3 – 6, 2019
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