Sample product 5

Sample product 5

£120

prcRoosterReplenishTM-MSC-CC is a xeno-free (XF), GMP concentrated bioreactor feed for use in fed-batch hMSC manufacturing bioreactor processes to eliminate media exchanges during rapid expansion of human MSCs for clinical allogeneic and autologous therapeutic cell manufacturing.

Engineered to achieve high cell growth in scalable (>50L) microcarrier-based suspension cultures when paired with our CC RoosterVial™-MSCs and prcRoosterNourish-MSC-CC while reducing contamination risks associated with in-process manipulation. prcRoosterReplenish-MSC-CC boosts media productivity (millions of cells produced per Liter of media consumed) by up to 70%, with each 100 ml bagged unit supplementing 5L of bioreactor expansion media.

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.

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Hi
Here you can see some frequently asked questions or contact us!

What passage are your cells?

Our human mesenchymal stem/stromal cells (hMSCs) are provided at a population doubling level (PDL) of 8-10 post-mononuclear isolation (Bone Marrow; Equivalent Passage 2) or 14-18 post-isolation from the perivascular region of Wharton’s Jelly (Umbilical Cord; Equivalent Passage 3). Due to variabilities of seeding and harvest densities we characterize our MSC “True Age” in terms of their PDL.

How often should I feed your cells?

A: There is no need to feed cells between passages. Our media is engineered to be a batch culture media, where no media exchange or feed is necessary when following our suggested protocols.

Are your vials sold from pooled donors?

No, we do not pool donors at any time during our production. Master Cell Banks (MCBs) are created from each donor source. Working Cell Banks (WCBs) are produced from our MCBs for general product sales.

What characterization do you provide for your hMSCs?

We characterize our hMSCs by following ISCT criteria: cell identity (surface marker expression), functional potency (angiogenic cytokine and IDO secretion), and trilineage differentiation (adipo-, osteo-, and chondrogenesis). This information is provided to allow customers to choose the optimal hMSC tissue type and donor for their specific application or target indication.