Newsletter | July 24, 2019

07.24.19 -- "We Do Everything" CDMO Pitch Not Pleasing Everybody

UPCOMING WEBINAR: How Quality By Design Changes Your Drug Product From Concept To Commercial

Tuesday, July 30, 2019 | 2:00 PM EDT, 11:00 AM PDT

In this free webinar, the featured speaker will demonstrate how the Quality by Design (QbD) cascade ensures FDA expectations are not only met but are clearly articulated in specific terms. This presentation will include an in-depth overview of all four stages of the QbD process. Register Now.

From The Editor
“We Do Everything” CDMO Pitch Not Pleasing Everybody
By Louis Garguilo, Chief Editor, Outsourced Pharma

Recent CDMO marketing extolling “the only end-to-end services" hasn’t been universally well received by the biopharma professionals it is targeting. Might we start questioning how truthful all CDMO marketing is as a result? That wouldn’t be good for the drug development and manufacturing outsourcing industry. 

Featured Editorial
Developing Optimal Pharmaceutical Quality Control Strategies
By Mark F. Witcher, Ph.D.

How can the industry improve the quality of its products? The first tactic could be to increase the frequency of vendor inspections, using internal quality control programs to inspect suppliers to assure compliance with the necessary supply agreements and adherence to appropriate manufacturing practices, including GMPs.

Industry Insights
In-House vs. Outsource: A Decision-Making Guide
White Paper | By B. Rosenblatt, Ph.D., SME Biotech Consulting, and D. Kenyon, Ph.D., Thermo Fisher Scientific

Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.

The Use Of Cell-Free Synthesis In The Future Of Modern Medicine
White Paper | By Daniel G. Bracewell, Professor of Bioprocess Analysis, UCL Department of Biochemical Engineering

Cell-free synthesis systems are well-suited to manufacture at the point of treatment, yet there are several challenges transitioning to this more efficient model for the future of medicine.

Is Your Biologic At Risk For Protein Aggregation? Part 2
Article | By Martin Gonzalez, Ph.D., Pfizer CentreOne Contract Manufacturing

How to prevent protein aggregation via considerations for the manufacturing process and container selection criteria. Part two of a three-part series.

A Bridge Over Troubled Water: The Journey To Serialization Compliance
Article | By Nicolas Girard, Ropack Pharma Solutions and Graham Clark, TraceLink

This regulation from the FDA outlined serialization and traceability requirements spread over the course of 10 years with preparation for each phase accumulating into a potentially high overall price tag.

A Systematic Approach To Extractables And Leachables: A Review Of Guidance From The Industry
Webinar | Nitto Avecia Pharma Services

This presentation discusses the basic definitions of extractables and leachables, including details from a case study done using prefilled syringes and a second using a single-use bag.

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