Introduction
Human mesenchymal stromal cells (hMSC) are considered the "workhorse" of Regenerative Medicine (RegenMed). hMSC are a critical starting material in a growing variety of established and emerging RegenMed products, including cellular therapies, cell-based gene therapies, hMSC-derived extracellular vesicles (EVs), and bioprinted engineered tissues (Olsen, 2018). Accordingly, there have been greater than 100 clinical trials initiated each year since 2011 using hMSC from various sources (database purchased from celltrials.org) across a host of indications and therapeutic strategies (clinical trials.gov). hMSC have benefitted from having an excellent safety profile, and there have been nine (9) products approved globally over the last 10 years. The growth in use of hMSC in a variety of product types has created the opportunity to standardize the supply chain and provide economies of scale for a rapidly growing industry. RoosterBio was founded to industrialize and standardize the RegenMed supply chain and to radically simplify the incorporation of living cells into therapeutic product development. Our goal is to have the same impact on the RegenMed industry that Intel had on the computer industry.
Human mesenchymal stromal cells (hMSC) are considered the "workhorse" of Regenerative Medicine (RegenMed). hMSC are a critical starting material in a growing variety of established and emerging RegenMed products, including cellular therapies, cell-based gene therapies, hMSC-derived extracellular vesicles (EVs), and bioprinted engineered tissues (Olsen, 2018). Accordingly, there have been greater than 100 clinical trials initiated each year since 2011 using hMSC from various sources (database purchased from celltrials.org) across a host of indications and therapeutic strategies (clinical trials.gov). hMSC have benefitted from having an excellent safety profile, and there have been nine (9) products approved globally over the last 10 years. The growth in use of hMSC in a variety of product types has created the opportunity to standardize the supply chain and provide economies of scale for a rapidly growing industry. RoosterBio was founded to industrialize and standardize the RegenMed supply chain and to radically simplify the incorporation of living cells into therapeutic product development. Our goal is to have the same impact on the RegenMed industry that Intel had on the computer industry.
Use of Human Umbilical Cord-derived MSCs (hUC-MSC) in research and clinical
trials (CT) has grown rapidly over the last 10 to 15 years with quickest
adoption in APAC (Figure 1, Davies, 2017; Zhao, 2018; Moll, 2019). hUC-MSC
publications per year increased 19-fold increase from 2006 to 2016 (Zhao, 2018).
CT with hUC-MSC have shown a similar growth pattern as publications. hUC-MSC
are the second most used hMSC type in CT (Moll, 2019) and 178 CT using hUC-MSC
were registered, are ongoing, or were completed between 2007 and 2017 (Couto,
2019). In fact, >30% of hMSC trials registered in 2019 use hUC-MSC as the
cell source. These drive the need for
hUC-MSC to use in product development. Until now, IP surrounding hUC-MSC has
been a primary roadblock to the widespread adoption of hUC-MSC. We have collaborated
with leaders in Wharton’s Jelly/umbilical cord hMSC at Tissue RegenerationTherapeutics Inc. (TRT) and have brought to market a complete bioprocess cell
and media system. RoosterBio’s hUC-MSC are available for licensing and are provided
in scalable formulations and cGMP compatible processes that enable anyone to
obtain hUC-MSC in numbers needed for incorporation into RegenMed product
development.
Until now
RoosterBio has paired our batch (2D) and fed-batch (3D bioreactor) bioprocess
media systems with hMSC from two sources: adipose-derived (hAD-MSC) and bone
marrow-derived (hBM-MSC and xeno-free (XF) hBM-MSC). RoosterBio’s launch of our XF hUC-MSC (RoosterVial™-hUC-MSC-XF)
introduces the first umbilical cord-derived hMSC in the North American and
worldwide market designed to meet the quality and volume needs of today’s
translationally focused cell therapy product developers. For RoosterBio’s hMSC
product lines see here.
RoosterBio’s RoosterVial-hUC-MSC-XF
and RoosterNourish™-MSC cell and medium bioprocess system has several key advantages over the limited
number of suppliers of perinatal hMSC. Being XF, and manufactured with
RoosterBio’s existing cGMP compatible processes, our system is the only hUC-MSC commercially available with a clear line of sight to
clinical translation. Additionally, other suppliers (a) provide low cell number
vials at a high price per M cells, (b) supply serum-based cells, or (c) require
specialized, non-scalable culture vessels.
Finally, RoosterBio provides first in class
characterization of hMSC key quality attributes (PDL, identity, expansion
potential) and functional assays (cytokine secretion, trilineage
differentiation, immunomodulation).
