RoosterCollect -Model EV-CC -cGMP Collection Medium for Extracellular Vesicles (EVs)
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.
- Low-particulate medium, manufactured under cGMP
- 1.5L EV collection medium in bagged format
- Protein-free | Chemically-defined
- For streamlined, scalable hMSC-based EV production
- Used with a qualified working cell bank and bioprocess media, RoosterCollect-EV-CC supports radical efficiencies in EV productivity and cost of goods in path to commercialization
- CliniControl™ EV Production system achieves clinically-relevant lot sizes in days, not weeks
- Per our process recommendations*, this bioprocess system provides scalable and reproducible generation of hMSC-EVs
- Supports flexible system integration to 10-layer vessel and closed system bioreactor processing
- Refrigerated product