Develop Successfully Together
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.
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.
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
We’re focused on getting your product to the finish line.