Newsletter | May 1, 2019

05.01.19 -- Here's An Idea: Let's Build A High-Potency Generics Facility

From The Editor
Here’s An Idea: Let’s Build A High-Potency Generics Facility
By Louis Garguilo, Chief Editor, Outsourced Pharma

In 2005, a couple of guys in Waterford, Ireland, got together and said: “There’s not enough high-potency, high-containment facilities in the world. Why not build one?” While they were at it, they also decided to focus a new facility on developing and producing innovative generics. What could be so easy?

Featured Editorial
5 More Best Practices Merck Used To Implement Strategic Sourcing Partnerships
By Panagiota (Pam) Rizos, associate director, external operations, global regulatory affairs and clinical safety, Merck & Co., Inc.

The first article in this two-part series described five best practices Merck undertook to effectively extend its capacity through strategic outsourcing to external partners. Here are the final five best practices, which focus on building a strong foundation with external partners.

Beyond Human Error: Are Blunt- Or Sharp-End Decisions More Important In The Life Sciences?
By Jim Morris, NSF Health Sciences Pharma Biotech

Decisions made upstream in the supply chain can have enormous repercussions downstream at the bedside or in the home, where medications are administered. How do we guarantee that the big and seemingly small decisions being made with each batch manufactured will be the “right” ones when there is so much inherent variability around us?

Industry Insights
How To Design Cell-Based Potency Assays
Article | By Aryo Nikopour and Ming Li, Ph.D., Nitto Avecia Pharma Services

Not seen on HGTV: Method design for cell assays. The many decisions when designing cell-based potency assays make home remodeling look easy.

Top 5 Events That Can Impact Your Clinical Supply Chain
Article | By Sylvia Tsengouras, Thermo Fisher Scientific

Review practical solutions for “small changes” in the clinical supply chain that can wreak havoc if not planned for in advance.

Guidelines To Bring Your Biologic To Market: Are You Prepared?
White Paper | GE Healthcare Life Sciences

Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective, some of the questions to consider in order to map out a successful pathway and avoid pitfalls along the way.

What Value Does An Integrated CDMO Bring To Your Outsourcing Strategy?
Article | Piramal Pharma Solutions

Should sponsor companies seek the traditional route of utilizing multiple partners across the supply chain? Or does an integrated CDMO offer a more efficient and faster path to commercialization?


In the context of ever-increasing drug potency, the 8th annual HPAPI Summit will provide you with real-world case studies from companies actively working with these compounds, enabling you to implement safe and robust practices in your own organization.

Incorporating insights from Genentech, Pfizer, Boehringer Ingelheim, SafeBridge, and AbbVie, you’ll leave this meeting with actionable insights enabling you to produce HPAPIs more robustly, safely, and cost-effectively.

More information.

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