Newsletter | July 10, 2019

07.10.19 -- How Important Is Geography To Today's Outsourcing?

  Development And Commercial Manufacturing Outsourcing Models

This market research report explores how sponsor organizations use contract manufacturers to streamline costs, better manage capacity, access scientific expertise, improve efficiencies. and decrease time-to-market. For this study, ISR surveyed a group of heavy outsourcers, making them well-qualified to give insight on their experiences using different outsourcing models, including tactical or transactional outsourcing, use of preferred providers, and strategic partnerships. Click here for more.

From The Editor
How Important Is Geography To Today’s Outsourcing?
By Louis Garguilo, Chief Editor, Outsourced Pharma

A recent CDMO press release essentially asserted superiority via proximity: Geography as God of outsourcing. I contacted two biopharma executives familiar with the Boston/Cambridge scene for reactions: Michael Kaufman, Senior Vice President, CMC, Mersana Therapeutics, and 15-year veteran of Merck; and George Avgerinos, Senior Vice President of Biologics Operations, Fortress Biotechnologies, and 22-year veteran of BASF/Abbott/Abbvie.

Featured Editorial
How To Ace Your Next CDMO Capabilities Audit
By Ray Sison, xCell Strategic Consulting, LLC

A capabilities audit is an integral part of a sponsor's due diligence in vendor procurement. It is often the sponsor’s first exposure to a CDMO’s operations, and the primary objectives are to evaluate the facility, equipment, quality systems, and the expertise of each functional team in relation to the specific needs of the project.

7 Tools For Breakthrough Quality And Performance In 30 Days
By Ben Locwin, Ph.D.

In this sixth installment on the selection and use of quality improvement tools in your organization, Ben Locwin wraps up the series with a treatise on the “Seven Tools of Quality.”

Industry Insights
How To Survive An FDA Audit
White Paper | By Paul Dupont, Ropack Pharma Solutions

Understanding the FDA audit process, preparing for it, and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.

Is Your Partner Prepared For Your Scale-Up And Commercialization Challenges?
White Paper | By Devan Patel, Pharmaceutics International

Most early-stage companies are not equipped with the means necessary for successful scale-up and commercialization, so it is critical you find a partner that can help you overcome the inevitable challenges of drug development.

A Plasma Problem: Dwindling Supply In The Face Of A Growing Demand
White Paper | By Andrew Goodsall, GE Healthcare Life Sciences

An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply in order to meet the needs of patients.

Real-Time Monitoring Of Pharmaceutical Shipments
Article | By Travis Hudson, Singota Solutions

Supply chain visibility is paramount, but what criteria should be considered when evaluating monitoring devices whose data can be accessed from the provider’s software platform in real time?

Is Your Biologic At Risk For Protein Aggregation? Part 1
Article | By Martin Gonzalez, Ph.D., Pfizer CentreOne Contract Manufacturing

This is the first installment in a three-part series that examines what causes protein aggregation and practical steps you can take to mitigate the risk.

The Pharma Trends You Need To Know: A CDMO’s Perspective
Article | By Anil Kane, Ph.D., MBA , Thermo Fisher Scientific

Companies must understand how today’s new pharmaceutical landscape is causing a dramatic shift in how we plan for and execute drug development and manufacturing.

Innovative Clinical Supply Solutions: Cold Chain
Case Study | Catalent

With our team of packaging experts and our extensive cold chain capabilities, this case study discusses the creation of a custom packaging and distribution solution to meet this client’s unique needs. Through our partnership, the product was successfully packaged in sufficient quantity and on time for the Phase 1 trial.

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