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From The Editor
Outsourcing On The Cheap To China?
 
By Louis Garguilo, Chief Editor, Outsourced Pharma

I’ve reached out to biopharma companies for answers to this question: “Why does your organization outsource so much drug development and manufacturing to China?” Prompted by President Trump’s remarks on the subject on October 1st, seems like a good time to present some of those initial industry responses, and further analysis of what we are facing.

 

Featured Editorial
How To Respond To A Failed Batch In A Virtual Supply Chain
 
By Hal Craig, founder, Trout Creek Consulting, LLC

You just received the urgent call, email, or text that a batch of commercial product made by your company’s outsourced supply chain has failed and, at first glance, the failure isn’t due to an analytical error. What do you do next?

What Is The Link Between Quality Metrics, Data Integrity, And Quality Culture?
By Sue Schniepp, Regulatory Compliance Associates Inc.

Quality metrics, quality culture, and data integrity are among the current and emerging topics of interest to the pharmaceutical industry of particular concern to both the industry and regulatory authorities. To understand how these three topics relate to each other, it is important to understand some of the history that led up to today’s environment, where quality metrics, quality culture, and data integrity come together in establishing current global regulatory expectations.

Industry Insights
Five Critical Mistakes To Avoid In API Development And Manufacturing
Article | By Raghavendar Rao Morthala, Ph.D., and Rajesh Shenoy, Ph.D., Piramal Pharma Solutions

In the rush to market, be aware of these critical missteps that can occur during the early development phases in order to avoid major challenges later during commercial API scale-up.

Six API Challenges That Could Be Slowing Your Development And How To Avoid Them
Article | By Andreas Stolle, Peter Poechlauer, Ph.D., and Bernt-Dietmar Schober, Patheon

Having a solid understanding of the most common API challenges can help avoid development delays, rework, or outright failure.

How A New Factory-In-A-Box Is Helping Scale Up Manufacturing Of Viral Vector-Based Therapies To Reach More Patients
Article | GE Healthcare Life Sciences

Manufacturing viral vector-based therapies, such as vaccines and gene and cell therapies, is complex, but a new manufacturing solution helps solve challenges.

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