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 Rooster’s human mesenchymal stem/stromal cell (hMSC) working cell banks and media systems with Sartorius’ single-use manufacturing tech, process control software and analysis tools.
The aim is to provide “robust, 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,” the firms say.
Billions of cells
Rooster Bio spokeswoman Carrie Zhang cited demand as the driver for the accord.
She told us “hMSC clinical development has never been more active, with over 250 clinical trials initiated globally in 2020 – a 50% increase over 2019 – with about 32% of these trials being sponsored by industry.”
Product development typically require billions of cells – Rooster Bio estimates that to get a therapy to market a firm will use more than 100 billion cells – which is a challenge for traditional flask-based manufacturing processes.
“Microcarrier-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.
“A 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.”
Zhang added that, “The 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.”
Therapeutic product developers will access the Rooster Bio and Sartorius systems as independent products according to Zhang.
“Rooster 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.”