Cell bank firm Rooster Bio has teamed with Sartorius to find ways of scaling-up production of stem cell-based regenerative therapies.
The collaboration will combine Roosterâ€™s human mesenchymal stem/stromal cell (hMSC) working cell banks and media systems with Sartoriusâ€™ single-use manufacturing tech, process control software and analysis tools.
The aim is to provide â€śrobust, streamlined, end-to-end platform technologies and protocols that can be implemented for rapid scale up of manufacturing processes, allowing product developers to significantly speed up their development timelines,â€ť the firms say.
Billions of cells
Rooster Bio spokeswoman Carrie Zhang cited demand as the driver for the accord.
She told us â€śhMSC clinical development has never been more active, with over 250 clinical trials initiated globally in 2020 â€“ a 50% increase over 2019 â€“ with about 32% of these trials being sponsored by industry.â€ť
Product development typically require billions of cells â€“ Rooster Bio estimates that to get a therapy to market a firm will use more than 100 billion cells â€“ which is a challenge for traditional flask-based manufacturing processes.
â€śMicrocarrier-based expansion in stirred tank bioreactor systems offer scalable manufacturing that can achieve lot sizes ranging from 25 billion to hundreds of billions of cells per lot.
â€śA well-executed bioreactor system, with high-quality starting materials and scalable hardware, can significantly reduce process development efforts, industrialize the supply chain and accelerate the development and commercialization of ground-breaking cell-based regenerative cures.â€ť
Zhang added that, â€śThe joint effort between Rooster Bio and Sartorius will standardize multiple unit operations in therapeutic hMSC manufacturing and will provide robust, streamlined, end-to-end solutions and protocols that can be easily implemented for the rapid implementation of cGMP production.â€ť
Therapeutic product developers will access the Rooster Bio and Sartorius systems as independent products according to Zhang.
â€śRooster Bio will continue to offer its process design and acceleration services to further enable our customers to establish a commercially viable biomanufacturing processes leveraging MSC bioprocess systems and relevant processing equipment.”