Some thoughts on US Cell Manufacturing Roadmap

by Alexey Bersenev on June 23, 2016 · 1 comment

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As you may know, last week US-based National Cell Manufacturing Consortium issued very interesting report – Cell Manufacturing Roadmap. What is it all about? Here is a quote from the report, which gives background information:

The Georgia Research Alliance (GRA) and Georgia Institute of Technology (Georgia Tech) recognized the opportunity to advance innovative technologies and techniques that can overcome current cell manufacturing challenges and support long-term growth of the cell manufacturing industry. Together, GRA and Georgia Tech established the National Cell Manufacturing Consortium (NCMC) and led the development of this roadmap, with funding from the National Institute of Standards and Technology (NIST) Advanced Manufacturing Technology Consortia (AMTech) program. This roadmap identifies challenges that currently constrain cell manufacturing and provides a pathway for developing, advancing, and implementing advanced technologies over the next 10 years to enable large-scale, cost-effective, reproducible manufacturing of high-quality cells.

You can also learn more from Georgia Tech press release. The report makes a point for necessary development of cell manufacturing technologies in US as national interest. The bulk of Roadmap is composed of actions plan for development of cell manufacturing technologies in the next 10 years. By some reasons, it gives confusing definitions, for example – autologous cells:

– cells harvested, expanded, and later administered to the same patient as a point-of-care cell-based medical product

Why narrow it to point-of-care? What about central manufacturing of commercial autologous cell products – the thing that many big industry players are trying to accomplish?

In general, plan of actions for the next 10 years, described in the Roadmap, is very good, I like and I agree with almost all of it, but… it left me with two big questions.

First, the Roadmap highlights the necessity for development of new tools and technologies, but it does not mention a great variety of currently existing tools. By some reasons, the Roadmap’s authors have ignored all that technological wealth, which was created by variety of manufacturers specifically for cell therapy industry or adopted from Biotech. Why so? I didn’t get it, guys. For example, Cell Processing Roadmap plan for the next 10 years –

* Define methods for growing autologous products in the absence of antibiotics
* Develop automated, closed systems that allow for parallel manufacturing of multiple patient samples
* Develop a reagent and method for large-scale T-cell activation

All of these have been done already! If currently available tools are not perfect, why not assess them in report, highlight advantages/ disadvantages and give expert’s opinion on necessity of developing new ones or improvement of existent ones?

I’ve picked only 3 examples, but the same thing applies to cell expansion, separation, storage, tracking, cryopreservation, monitoring, quality control… There are hundreds of tools available right now! I think, we actually have the opposite problem – too many tools to try and play with! Not enough time, money and manpower to try them all and pick a few!

My second question is who and how will execute the Roadmap’s proposed plan? Yes, a lot of things must be done in order to get US to the next level in cell manufacturing, but who will do it all and how will it be monitored? Some positions from 9-years plan in the Roadmap look too ambitious to me. They could be accomplished only with great financial support, strong leadership and sophisticated management system. The Roadmap is a request for financial support, but we don’t know for sure how well it will be funded by government. Also, there is no NCMC org chart to monitor plan execution and efficiency.

It’s very hard to imagine how all positions in cell manufacturing technologies roadmap could be executed in the next few years. For example, who will search for manufacturers and tell them what to do? Who will ask FDA to create working groups and who will ensure their function? I have the same questions about creation of workforce and training. Examples from training roadmap:

* Launch graduate and postdoctoral industry internships that include preparatory curriculum with instruction on industry skills for productivity (e.g., how to keep a laboratory notebook, how to manage intellectual property), case studies of successful and failed processes and products, and rapidly changing guidance documents such as those from the U.S. Food and Drug Administration (FDA)
* Create a university training model with continuous industrial engagement (e.g., survey industry on needed skills and knowledge gaps) in areas of cell manufacturing knowledge, including logistics, revenue, intellectual property, and confidentiality
* Engage local community and technical colleges to help train the entry-level workforce in the skills that industry has identified as critical to advancing cell manufacturing

All these must by accomplished by 2018, according the plan. I love the idea, but is it realistic to accomplish in 2 years?

Overall, it is very interesting document. Even if only half of proposed plans will be accomplished in the next 9 years and if it will be funded, I’ll be very happy. I hope, some authors of the Roadmap will read this post and clarify my questions.

{ 1 comment… read it below or add one }

Tracy June 24, 2016 at 3:08 pm

You make some excellent points here. Easy to write a document, execution and money are the challenges.

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