cGMP Collection Medium for Exosomes / Extracellular Vesicles (EVs)
RoosterCollect™-EV-CC is a chemically defined extracellular vesicle (EV) collection media designed to seamlessly integrate into EV, exosome, or cell secretome production platforms. Designed for EV manufacturing across many cell and tissue types in both 2D planar and 3D bioreactor culture conditions, this protein-free and low-particulate media enables “clean collection” resulting in higher yields and easier downstream processing.
RoosterCollect™-EV-CC is easily integrated into existing GMP workflows to support EV collection from preferred cell types, or when combined with RoosterBio’s hMSCs and expansion media, RoosterCollect™-EV-CC turns the RoosterBio cell culture platform into a highly optimized extracellular vesicle production platform.
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.
*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.