RoosterBio recently hosted a webinar called “Planning a Successful MSC Therapy for Rapid COVID Response” to address challenges that mesenchymal stem/stromal cell (MSC) therapy developers might face to manufacture sufficient doses to treat COVID-19 patients suffering from acute respiratory distress syndrome (ARDS) or other related indications.
The speakers, Dr. Mayasari Lim and Dr. Timothy Olsen from RoosterBio, are bioprocess veterans with many years of experience in the regenerative medicine field. During the webinar, they discussed the inherent bottleneck in current 2D planar systems, a.k.a. “The COVID-19 Challenge.” Even when using multi-layer vessels such as CellSTACKS, manufacturing lot sizes for optimized cultures are limited to 10-15B cells per run. While multi-layer vessels are sufficient in meeting requirements for many Phase I and II MSC trials, they will not be practical for larger scale manufacturing in meeting the needs of a global health crisis like COVID-19.
Here are key highlights from the talk, presented in Q&A format:
What are the production needs for COVID-19?
To assess the production needs for the COVID pandemic, RoosterBio’s team has performed calculations based on assumptions that account for product loss, downstream processing, quality control, and recommended 50% overfill to arrive at a production need of at least 6.4 trillion cells, for a target dose of 300M cells for 10,000 patients. If you’d like to understand how to perform this calculation and the assumptions used, read this blog on estimating production lot sizes.
How many manufacturing lots are required for 10,000 doses?
Using 10-layer CellSTACKS which can generate 10B cells per lot, this would require 640 manufacturing runs. In contrast, when using a microcarrier based bioreactor culture, at a 50L scale which generates up to 30B cells lot size, this would require 215 runs. It was shown that one benefit of bioreactor use is that it can be scaled up. So, at 500L bioreactor scale, it would reduce the manufacturing runs to about 20. Until now, there hasn’t yet been a demand to warrant such R&D studies.
What else would you need to be manufacturing ready?
Manufacturing Readiness Level (MRL) is an indicator of the ability of a product to be manufactured and manufacturing that is ready to implement is critical for a rapid response to pandemic. Aligning to MRL principles, RoosterBio offers manufacturing bioprocess recommendations to its prospective customers interested in MSC products directed at COVID-19 related indications:
- Off-the-shelf and ready to deploy inventory of cGMP human bone marrow MSC working cell banks and bioprocess expansion media for manufacturing MSC based therapeutics.
- GMP working cell banks and expansion media are supported by US FDA Master files along with industry leading characterization profiles.
- GMP compatible bioprocess recommendations and protocols that are ready to be implemented at your cGMP manufacturing facility.
- GMP grade media for collection of extracellular vesicles (EVs).
- Transparent and traceable development services enabling streamlined technology transfer back to your organization or to a CMO for further cGMP manufacturing.
In conclusion, finding the right partner is really one of the most critical elements to ensure a smooth and successful execution of any MSC therapeutic manufacturing program. RoosterBio has the experience and expertise in scalable MSC manufacturing to help MSC therapy product developers succeed, no matter what stage they are at and are actively working with a handful of companies to support their IND filing.
RoosterBio offers a great blog series on COVID 19 which can help you understand at a deeper level on how hMSCs and scalable manufacturing play into a rapid COVID-19 Pandemic response. Click here to learn more.
About RoosterBio, Inc
RoosterBio is a privately held cell manufacturing platform technology company focused on accelerating the development of a sustainable regenerative medicine industry, one customer at a time. RoosterBio’s products are high volume, affordable, and well-characterized adult human mesenchymal stem/stromal (hMSCs) paired with highly engineered media systems. RoosterBio has simplified and standardized how living cells are purchased, expanded and used in development, leading to marked time and cost savings for customers. RoosterBio’s innovative products are ushering in a new era of productivity and standardization into the field, accelerating the road to discovery in regenerative medicine. Visit http://www.roosterbio.com.