Rapidly Move Your Programs to Clinical Translation with RoosterBio Process Design & Acceleration Services
From Day 1, our goal at RBI has been to Accelerate the RegenMed Industry, one customer at a time. We are launching targeted "Acceleration Services" to help our customers develop commercially-viable biomanufacturing processes that are scalable and right-sized for their phase of development; with a COGs profile that enables their business model. Resetting the structures of development programs radically shortens timelines, streamlines regulatory filings, and stretches $$$$ further.
Our focus on hMSC TECHNOLOGY-BASED PRODUCTS GETS YOU TO THE FINISH LINE, FIRST
We make you the priority
We work with you to design cGMP-compatible processes & facilitate a tech transfer back to you as well as to your CMO to guide final product manufacturing and release. We deliver CMC-ready documentation to drive tech transfer, knowledge transfer, and IND filings.
RBI clinically-relevant starting materials paired with your commercially-viable manufacturing process reduces regulatory burden and minimizes the need for costly, late-stage process changes. Further, it's critical to transfer & control the value created. Our capabilities include: Upstream & downstream process development, COGs modeling & optimization, and analytical services. We also work with tools providers to generate data packages qualifying devices against traditional processing methods.