From The Editor | March 13, 2019

3 Business Challenges from the CDMO's Perspective

Erin

By Erin Harris, Editor-In-Chief, Cell & Gene
Follow Me On Twitter @ErinHarris_1

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Partnering with a CDMO that marries innovation with technical, regulatory, and manufacturing experience can be cell therapy and gene therapy companies’ best opportunity for scalability and yet their biggest hurdle. From process development through commercial supply and all the steps in between, cell and gene therapy companies expect CDMOs to meet an understandably high bar.

I recently had the opportunity to take a quick trip down 76 East to WuXi AppTec located in Philadelphia’s Navy Yard. I toured WuXi’s Manufacturing suits, which is where they company does its Viral GMP production. I also toured their Testing suits, which includes the WuXi’s Testing and GMP production building. The tours were informative and helped me shape my questions for the second half of my visit, which was a sit down with WuXi’s SVP and Global Head of Wuxi Advanced Therapies, Felix Hsu.

Hsu and I had a great conversation around the CDMOs perspective on manufacturing, and I feel the outcomes of our conversation can benefit our readers. Here’s why.

He and I talked about the top challenges WuXi’s clients bring to the table. As you research and visit CDMOs that can potentially execute your vision, consider how you and your team can address these three challenges. Does any of this sound familiar?

1. Time.

Hsu assured me that WuXi’s clients often have more money than time. Or, clients have developed a platform and sometimes expect to accelerate this platform without a well-characterized process — or very little process in place. Accelerated timelines to meet an IND date won’t always work for the CDMO in these circumstances, and the timelines are often aggressive or unrealistic.

2. Stop tinkering.

Hsu stressed that how things work in an academic setting is different from how they work for GMP manufacturing. And, so, scientists sometimes have a difficult time accepting that they cannot continue to work on process and must stop making changes to move forward with GMP manufacturing.

3. No last-minute changes.

He explains that sometimes clients struggle to determine exactly what they want or need in terms of the assay development in the timeframe needed. As always, time is a major factor and manufacturing is one of the biggest decisions your organization will make. Academic labs vary greatly from manufacturing environments and have greater flexibility; CMDOs often cannot allow last-minute changes to the process and/or raw materials if they are to meet tight deadlines.

What has your experience been with partnering with CMDOs and how has your organization learned? Email me directly to share your insight.