RoosterCollect™-EV-CC is a standardized chemically defined, and low particulate collection medium for scalable and streamlined extracellular vesicle (EV) collection. RoosterCollect-EV-CC is one component of RoosterBio’s CliniControl™ EV Production System – a bioprocess engine for rapid EV manufacturing for use in cGMP and clinical applications. Each bag of RoosterCollect-EV-CC is engineered to support and integrate with RoosterBio’s batch (2D) and fed-batch (3D) CliniControl™ hMSCs and bioprocess media to support a rapid path to phase 1 and scaling to grow with your clinical progression.
RoosterCollect-EV-CC is an ancillary material manufactured under good manufacturing practice (GMP) conditions. Regulatory support is available to supplement the chemistry, manufacturing, and control (CMC) section of investigational new drug (IND) applications.
RoosterBio’s CliniControl hMSCs, bioprocess media, and EV collection media can efficiently accelerate your clinical cGMP extracellular vesicle (EV) production workflow.
*Product needs will be dependent on customer’s process.
Intended Use: For Further Manufacturing Use Only. Not intended for diagnostic use or for direct therapeutic human or veterinary use.
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The bag was designed to include common connections and weldable tubing to be compatible with a wide range of bioreactor systems and flasks either directly or by accessory parts – some readily available, others that can be designed and ordered through parts distributors. Please, refer to the bag drawing for tubing and connection details to determine the best options for your system.
The bag film is a polyethylene-based film that has been widely-used in industry for >10yrs. More information including a summary of the validation package can be accessed through customer support, your commercial team representative, and/or during audits.
This EV collection media and the recommended protocol were developed with RoosterBio CliniControl hMSCs and bioprocess media system, but it may work well with other cell types. We recommend testing it out in your system.
Every lot of media is ensured to have a low concentration of particles between 50 and 1,000 nm to ensure that the collected EVs are from the cells and not introduced by the media.