RoosterCollect™-EV-CC

cGMP Collection Medium for Extracellular Vesicles (EVs)

Designed for simplified, clean 2D and 3D bioreactor hMSC-EV collection that can be taken into late stage development and cGMP manufacturing.
Overview

Overview

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 Features

  • 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

*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.

Figure 2(a). RoosterCollect™ is a low particle, low noise medium engineered for extracellular vesicle collection.
Figure 2(b). RoosterCollect™ supports scalable EV collection from 6 to 72 hours in both 2D vessel and 3D bioreactor systems (up to 15L shown).
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Scientific Resources FAQs

Will this product work with my flask or bioreactor system?

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.

What material is the bag film comprised of?

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.

Will this media work with my cell type?

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.

What is meant by a low particulate medium?

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.

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