Newsletter | February 12, 2020

02.12.20 -- The Biggest CDMO Show On Earth

From The Editor
The Biggest CDMO Show On Earth
By Louis Garguilo, chief editor, Outsourced Pharma

I suppose it was inevitable. After years of escalating one-upmanship in the CDMO industry, it was only a matter of time before we got the “biggest CDMO on the planet” announcement. But more details were needed. We’ve now got them for you.

Featured Editorial
EMA Publishes Updates To Its New Requirements For Nitrosamines
By Barbara Unger, Unger Consulting Inc.

This article, originally published in November 2019, has been significantly revised and expanded to address new information issued by the EMA on December 20, 2019. Specifically, the agency modified its original responses to questions 11 and 12 and added questions and answers 13 through 16 to its Q&A on potential nitrosamine contamination.

Packaging Good Manufacturing Practices (GMPs) For Medicinal Products
By Mark Durivage, Quality Systems Compliance LLC

Has your supplier of primary packaging materials for medicinal products established and implemented — and continued to maintain — an adequate quality management system (QMS)? Generally, most suppliers of packaging materials maintain an ISO 9001 QMS. However, the requirements of ISO 9001 may not provide the necessary levels of good manufacturing practices (GMPs) and rigor to ensure the packaging materials are adequate for their intended use.

Industry Insights
Guide Clients Through Drug Development With Intelligent Collaboration
Q&A | A Q&A with JoyL Silva, Pfizer CentreOne Contract Manufacturing

This article recounts a recent discussion with the general manager of Pfizer CentreOne regarding what it’s like to lead an embedded CDMO within one of the largest pharmaceutical companies.

Component Selection: The Key To Your Program Success
White Paper | Ajinomoto Bio-Pharma Services

The increasing global adoption of injectable medicines creates demand for pre-filled syringes and vials. CDMOs that provide aseptic fill and finish services are actively responding to this increased demand.

Understanding And Controlling Raw Material Variation In Cell Culture Media
White Paper | GE Healthcare Life Sciences

An organized effort across biopharma, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.

Partnering With Your Teams To Enhance And Increase Supply Chain Efficiency
Case Study | Thermo Fisher Scientific

An emerging biopharmaceutical company teams up with a clinical services company to stay on track with timelines and ensure funding milestones are met when faced with unexpected lack of bandwidth and limited global organizational experience.

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