May 2020
Volume 33, No. 5 |
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Notice to BioPharm International subscribers currently receiving printed copies of the magazine:
Many readers working remotely may not have access to the print versions of BioPharm International; therefore, for upcoming issues, we will deliver the digital version of the magazine to you via email. Your print issues will continue to be delivered to you via postal mail and will be awaiting your return to the office. If you wish to change your delivery address, or delivery preference, you can do so via our online subscription form.
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| COVER STORY |
Feliza Mirasol
Viral vectors show promise as a delivery mechanism for gene therapy, but which virus types are commercially viable?
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| UPSTREAM PROCESSING |
David McElroy
Synthetic biology has advanced the scope and scale with which biologically derived therapeutics can be developed.
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| DOWNSTREAM PROCESSING |
Jennifer Markarian
Pumps and other components meet the demands of single-use systems in biopharmaceutical downstream processing.
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| BioPharm International May Issue
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| MANUFACTURING |
James P. Agalloco
The industry’s aversion to risk has led to its treating closed aseptic processing systems as miniature cleanrooms, resulting in redundant and expensive practices. This article ponders this impasse, examining new technologies and applications in light of past regulatory guidance and more than 40 years of operating evidence.
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Featured Resources from BioPharm International
View our online resource center, sponsored by GE Healthcare, to explore a case study and articles on gaining and retaining skilled labor, modular bioprocessing, the good and bad of biosilimiars, and more.
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| ANALYTICS |
Cynthia A. Challener
Next-generation therapeutics and regulatory requirements create demand for complex, fit-for-purpose tests.
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| PEER-REVIEW RESEARCH |
Dipanwita Batabyal, Libo Wang, Jeffrey Zonderman, Mats Wikström
In this peer-reviewed article, the authors present a series of experimental studies showcasing the performance of MMS in secondary-structure biopharma characterization and compare it with conventional FTIR data.
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| QUALITY/REGULATIONS |
Lauren Lavelle
Having remote operations in place is crucial to maintaining good automation practices.
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| OUTSOURCING |
Eric Langer
But are innovations sufficient to increase adoption? CMOs are demanding better continuous bioprocessing options.
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| FROM THE EDITOR |
Rita C. Peters
Will moving at “warp speed” to develop a vaccine impact efficacy or safety?
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| REGULATORY BEAT |
Jill Wechsler
Policy makers seek to ensure supplies of new therapies and to limit shortages.
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| ASK THE EXPERT |
Susan J. Schniepp
Having a better understanding about compliance will be of benefit when looking for a job or for furthering one’s career, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
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WEBCASTS
Practical Method Development Strategies for the Analysis of Monoclonal Antibodies by Reversed-Phase HPLC
Thursday, May 21, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Vaccines Illuminated: Biophysical Characterization, PAT, and Quality Control via Light-Scattering Techniques
Tuesday, May 19, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Are You Seeing the Whole Picture? Backgrounded Membrane Imaging (BMI) as a Multi-Use Analytical Tool for Developability Assessment through Late Stage Formulation
Tuesday, May 12, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Accurate Weighing of Reference Standards in a QC Laboratory
Thursday, May 28, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST
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| EVENTS |
June 8–12, 2020
August 24–26, 2020
September 30–October 2, 2020
more events
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