RoosterBio is Ready to Deploy cGMP Cellular Starting Materials for Your hMSC Based Therapeutic Development

The current COVID-19 global pandemic requires a rapid deployment of resources to combat and contain the outbreak with diagnostics, vaccines, and therapeutics. RoosterBio is the only company in the world with an off-the-shelf and ready to deploy inventory of cGMP human bone marrow hMSC working cell banks and bioprocess media for manufacturing hMSC based therapeutics. Partnered with bioprocess recommendations and protocols, these cellular starting materials are ready to be implemented immediately at your cGMP manufacturing facility for further manufacturing of therapeutic doses. Equipped with U.S. FDA Master Files and industry leading characterization profiles, RoosterBio’s starting materials will streamline your IND submission and clinical translation.


With 70% of cell therapy clinical trials for COVID-19 being MSC-based, MSCs are in the forefront due to their anti-inflammatory and immune-modulatory capabilities. It is very important to know how to scale up your MSC production and manage risks in order to simplify and accelerate your transition into cGMP manufacturing for clinical testing. View our COVID-19 Webinar Recording to learn more on how to plan a successful Mesenchymal Stromal/Stem Cell (MSC) therapy for rapid COVID response!



Scalable hMSC Manufacturing Systems for Pandemic Level Response

Rapid development and deployment of therapies are necessary to address the urgent need for current and future COVID-related pandemic responses. By leveraging our team of hMSC manufacturing experts, you can develop clearly defined strategies to streamline and rapidly implement your path to clinical manufacturing. RoosterBio has cGMP compatible protocols that allow for manufacturing of therapeutic doses to begin immediately in a 2D flask-based system with basic cell culture infrastructure (biosafety cabinets, incubators, centrifuge). In parallel, RoosterBio can support the initiation and execution of a technology transfer for a 50L bioreactor process, and larger. These manufacturing strategies allow for clinically and commercially relevant lot sizes to be produced, which is critical for treating larger patient populations in a pandemic.



Standardized 2D (Flask) and 3D Bioreactor Based hMSC Manufacturing Systems

RoosterBio’s hMSC manufacturing utilizes consistent Chemistry, Manufacturing, and Controls (CMC) across scales and culture platforms to ensure consistent and robust therapeutic manufacturing. Click here to learn more about our CliniControl™ product offerings.


Ready to Take Your Therapeutic to Clinical Manufacturing for a COVID-19 Related Indication?

Urgency is key to deployment of patient ready therapeutics. Off-the-shelf and scalable hMSC manufacturing solutions in both 2D and 3D platforms are available to address the high cell numbers required for treating the tens of thousands of patients suffering from severe COVID-related indications, like ARDS, pneumonia, and cytokine storm. Discover more by speaking with one of our experts.


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