Newsletter | April 1, 2020

04.01.20 -- Biopharma Answers Supply-Chain Questions Raised By COVID-19


The Coalition for Epidemic Preparedness Innovations (CEPI) is urgently developing vaccines against COVID-19. CEPI is inviting Expressions of Interest from sponsors and CROs with experience in clinical trials with human vaccines, to support clinical trials of COVID-19 vaccines. Applications from LMIC-based entities are encouraged. More information and submission details here. Submissions close at 15.00 CET on 19th April.

From The Editor
Biopharma Answers Supply-Chain Questions Raised By COVID-19
By Louis Garguilo, Chief Editor, Outsourced Pharma

In terms of increasing transparency regarding the location of production, Novartis, Regeneron, GeoVac, and Gilead are positive examples for Outsourced Pharma readers.

Six Degrees Of Frank Gupton (And Continuous Manufacturing)
By Louis Garguilo, Chief Editor, Outsourced Pharma

In the course of an hour, Frank Gupton mentions the highest level government officials; Janet Woodcock of CDER; Scott May of Eli Lilly; an ongoing project with DARPA; and others. They all come to the professor for help with U.S.-based manufacturing, and particularly the art of continuous manufacturing.

Featured Editorial
FDA FY2019 Warning Letter Trends: A Closer Look At Drug Product Manufacturers
By Barbara Unger, Unger Consulting Inc.

This is the second article in a two-part series reviewing the FDA’s GMP drug warning letters from FY2019. Part 1 provided a high-level overview of the FY2019 data, including trends since FY2013. In Part 2, we take a deeper dive into the types of drug product manufacturers that received warning letters and their locations.

Microorganism Challenges On Online Water Bioburden Analyzers: Pitfalls And Best Practices
By Cynthia Martindale (Applied Rapid Microbiology Specialists, Ltd.), Scott Hooper (Merck), Miriam Guest (AstraZeneca), Hans-Joachin Anders (Novartis), Ulrich Georg Zuber (Roche), and Mike Russ (Genetech)

This is the second article in a two-part series on conducting microorganism challenge studies using online water bioburden analyzers (OWBAs) in a laboratory setting. Part 1 discussed two different experimental approaches that have been successfully used for microorganism challenges. This second article explores the six pitfalls to avoid and four best practices to follow during execution of microorganism challenge tests.

Industry Insights
Built To Fail: How Today’s Manufacturing Options Leave Pharma At Risk
Article | By Joe Principe, Thermo Fisher Scientific

Though pharma companies do their best to understand the environment, it can be very difficult to predict demand, and the consequences of incorrect forecasts can be very costly in a number of ways. 

Strategies To Address The Viral Vector Manufacturing Shortage
White Paper | By Florence Vicaire, GE, Joe Makowiecki, GE, and Carol Houts, Germfree

Accelerating the production of your viral vector-based therapy requires you to understand the strategies available to address the viral vector manufacturing shortage as well as selecting the most cost-effective solution for advancing your therapeutic.

The Supply Chain Executive’s Perspective On Single-Supplier CDMOs
Q&A | Thermo Fisher Scientific

A single vendor offers access to a network of experts who can share knowledge about a project as it moves from phase to phase, thus helping to navigate its path toward commercial success. 

Expert Advice For All Facets Of Managing Your External CMC Partners

More outsourcing needs to translate to better outsourcing — improved efficiencies, productivity, speed, and CDMO relationships. Easier said than done. But no internal function at a biotech or pharma company can do more to accomplishing these improvements than the CMC group. We’ve collected a series of editorials that feature some frontline examples, and best practices, from a variety of CMC practitioners. Access this free resource.

Single-Use Bioprocess Containers
Thermo Fisher Scientific Bioproduction
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