Process Development Services

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

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Process Development Services Tech Sheet
Process Development

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.

“RoosterBio provided great communication both ways with timely and productive meetings, as well as great teamwork and scientific expertise synergy. They offer great flexibility, excellent quality of data presentation and reporting, and optimal quality for scientific results while facilitating the optimization and implementation in process development projects.”

Anonymous Customer

“When my MSC program was moving into bioreactors and I needed the hands-on know-how transferred to my team, RoosterBio invited me to their facility to observe and actually participate in a 15L bioreactor run. The knowledge obtained was a quantum leap for our bioreactor programs, leading to early success in my laboratories. I would certainly recommend them as a partner when your program is ready to scale-up.”

Anonymous Customer