Newsletter | March 18, 2020

03.18.20 -- Don't Spread The Wrong Message: COVID-19 And Respect For CMOs

From The Editor
Don’t Spread The Wrong Message: COVID-19 And Respect For CMOs
By Louis Garguilo, Chief Editor, Outsourced Pharma
The first event would be a celebration for safely, reliably, and productively keeping drug development and manufacturing supply chains running. The second event came at us as a threat to shut those supply chains down. But here’s an added irony: This new coronavirus may have provided our industry an opportunity of sorts.
Sign It, President Trump; Don’t Go There, President Xi
By Louis Garguilo, Chief Editor, Outsourced Pharma

If drugs are discovered as purposefully held up by China to create a supply issue in the U.S., would you ever again employ a China-based CMO? Who would have thought Outsourced Pharma readers would be front and center in presidential politics? But you are.

Featured Editorial
An Analysis Of FDA’s Recently Issued Gene Therapy Guidances
By Kalah Auchincloss, Greenleaf Health

The FDA has finalized six draft guidance documents intended to serve as part of a modern, comprehensive framework for how the agency will help advance the field of gene therapy. At the same time, it issued a new draft guidance on determining “sameness” of gene therapy products for the purposes of orphan drug designation/exclusivity. This article highlights key changes made in each of the final guidances and also reviews the new draft guidance.

Experimental Methods For Microorganism Challenges On Online Water Bioburden Analyzers
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)

Implementing online water bioburden analyzer (OWBA) technology often includes laboratory microorganism challenge testing to verify that the instrument is suitable for its intended use. This requires the end user to select microorganisms for testing and successfully create quantifiable suspensions of these microorganisms for OWBA analysis. While this would seem straightforward, several aspects of preparing microbial challenges can easily derail the best-intended experimental design.

Industry Insights
Securing Today’s Biomanufacturing Supply Chain Using Transformative Supply
Article | By Sofie Stille, GM BioProcess Resins & Technologies, and Elles Steensma, GE Healthcare Life Sciences

Managing the complexities of today’s supply chain begins with transforming relationships that are historically transactional to those that drive suppliers to become value-add partners working toward shared goals with their customers.

The 3 Cs You Should Expect From Your Pharma Service Provider
White Paper | By Yves Massicotte, Ropack Pharma Solutions

When asked about the biggest challenges to the pharmaceutical company sponsor-contract service provider relationship, sponsors and service providers offer pretty consistent responses.  

The Right Biomanufacturing Partner Can Mitigate Forecasting Risks
Article | Thermo Fisher Scientific

While forecasts can never be 100-percent accurate, the goal for biopharmaceutical forecasters should be to minimize the degree of inaccuracies as much as possible.

Critical Factors Of Fill/Finish Manufacturing For Large Molecules
White Paper | Ajinomoto Bio-Pharma Services

Large molecules require special handling procedures for bulk drug substance, formulation, and sterile filtering and filling of the final drug product, forcing change on many levels of the manufacturing process.

Improving Manufacturing Outsourcing Relationships
Infographic | ISR Reports

In Q42018, ISR asked 100 sponsors who outsource manufacturing about several different scenarios that could potentially improve outsourcing relationships. The data below shows how each of the scenarios panned out. A key common element across the most likely scenarios — communication.

Softgel Technologies
Thermo Fisher Scientific
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