The path to IND approval for cell-based therapies can be challenging and time-consuming with strict regulatory requirements. That is why RoosterBio provides Process Development Services to help you build clinical phase-appropriate cGMP processes for your specific product needs.
We have served many customers to streamline the path to clinical testing with our industry-leading hMSC bioprocess systems. Our solutions will enable your custom manufacturing process to align with regulatory guidance, be scalable to fit future needs, and rapidly turn your product concept into a clinically tested therapeutic. Join the growing number of companies benefiting from a customer-centric approach that accelerates their path to commercialization.
Develop Successfully Together
Our process development services include:
- Upstream culture and harvesting
- Downstream volume reduction, purification, and vialing
- 2D scale-out or 3D bioreactor scale-up
- hMSC integration into cell-based therapies
- Exosome and EV production, collection, and purification
- hMSC-based gene therapy/modification
RoosterBio can provide you with innovative core technology, years of solid experience, and a strong foundation to support your hMSC-based cell manufacturing programs. We have a history of great success in radically shortening development timelines into cGMP manufacturing.
We’re focused on getting your product to the finish line.