Cell & Exosome Media

Overview

^prcRoosterNourish™-MSC-CC is RoosterBio’s xeno-free (XF), GMP bioprocess medium designed to eliminate media exchanges during rapid expansion of human MSCs for clinical allogeneic and autologous therapeutic cell manufacturing. Formulated utilizing irradiated ‘pathogen reduced components’ (prc), this medium provides an enhanced regulatory profile to meet evolving global guidances.

This medium supports in vitro expansion of hMSCs in a 2D batch process or in a 3D bioreactor fed-batch process with our ^prcRoosterReplenish™-MSC-CC bioreactor feed, achieving unparalleled productivity (Millions of cells produced per Liters of media consumed) compared to other MSC media on the market. Used alongside our CC RoosterVial™-MSC and following RoosterBio^® protocols, this system generates the billions of cells necessary to meet clinical needs.

CliniControl™ bioprocess media are manufactured with methods and controls that conform with current Good Manufacturing Practices (cGMP) and are supported for use as an ancillary material by a Type II Master File on file with the FDA. Time spent on investigational new drug (IND) submissions is significantly reduced by facilitating CMC documentation.

Product Features

• Xeno-free | cGMP | Pathogen Reduced (prc)*
• No media exchanges required
• hMSC expansion media for batch and fed-batch (when using ^prcRoosterReplenish-MSC-CC) culture systems
• No surface coatings required when using Corning CellBind™ surfaces
• (K81014) 500 ml bottle RoosterBasal™-MSC-CC with 10 mL bottle of ^prcRoosterBooster™-MSC-CC
• (K81001) 10L bagged RoosterBasal™-MSC-CC with 2x 100 mL bags of ^prcRoosterBooster™-MSC-CC
• Available in custom formats
• Supported by US FDA Type II Master Files – available for cross reference

Intended Use: For Further Manufacturing Use Only. Not intended for diagnostic use or as an excipient for direct human or veterinary therapeutic use.

*’prc’ denoted products have been manufactured using pathogen reduced components to meet evolving regulatory needs and standards.