From The Editor
Internal Processes And Attitude Drive Outsourcing Outcomes
 
By Louis Garguilo, Chief Editor, Outsourced Pharma

Take it from an organic chemist, who transitioned from the bench to cross-functional leadership and CMO management at companies such as Amgen, Baxter/Baxalta, Shire, and now ImmunoGen: Outsourcing effectively starts with realizing "the value of establishing consistent internal processes for all activities.” And, he adds, bring a bit of attitude to your service providers. 

Featured Editorial
CDMO Selection: 3 Questions To Save Time And Reduce Stress When Reviewing An MSA
 
By Ray Sison, xCell Strategic Consulting, LLC

Whether because of unfamiliarity or lack of resources, master service or supply agreement (MSA) execution can be time-consuming and difficult. An MSA is not a novel, read from front to back — it is a functional legal document that provides operational, financial, and legal guidance that will be referenced as needed throughout the term of the agreement.

Cryogenic Transport For Gene Therapy Products: The Pros And Cons
By Faryar Tavakoli, packaging program manager, Adept Packaging

Temperature-controlled packages used for the transport of gene therapy products use a combination of thermal insulators or thermoregulators to decrease the heat transfer rate from outside of the shipper to the inside. In this two-part article, we will explore common methods of temperature-controlled transportation and delve into their pros and cons. In Part 1, we focus on passive cryogenic options.

Industry Insights
Fermentation Optimization: Using Comparative Statistics To Enhance Large-Scale Process Productivity
Article | By Jonathan M. Glynn, Ph.D., Pfizer CentreOne Contract Manufacturing

Using a case study, the author demonstrates how comparative statistical analysis enabled his team to improve the yield of a component used in API synthesis by more than 2.5 x 108 U/batch.

The Advantages Of A Cross-Functional Staff Model In Pharmaceutical Manufacturing
Article | By Tommy Bowlen, Singota Solutions

An individual that knows the product and processes from start to finish, having performed the tasks at each stage, gives the client reassurance and the CMO retains a valuable employee by avoiding burnout or loss of focus.

Why Early Investment In A Scalable Manufacturing Process Is Critical
Article | By Enrico Corona and Jonathan Sutch, Thermo Fisher Scientific

The failure of drug compounds in mid- to late-stage development is far more common than anyone would like it to be. Only about 30 percent of compounds successfully transition from Phase 2 to Phase 3.

6 Regulatory Changes Affecting Bioprocessing In China
White Paper | By Scott M. Wheelwright, cofounder and principal consultant, Complya Asia

This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

Scaling Up Or Transferring Your API Manufacture? 3 Considerations To Manage Risk And Improve Efficiency
Article | Piramal Pharma Solutions

Scaling or migrating active pharmaceutical ingredient (API) manufacturing requires careful planning and a strategic mindset. In this white paper, learn how to scale and migrate the right way.

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