Frequently Asked Questions

Products / Services / Manufacturing

What is perinatal tissue?

OrganaBio has established a proprietary supply chain for ethically-sourced perinatal tissues. Perinatal tissues are in-utero tissues that support the growth and development of a baby prior to birth. Some examples of perinatal tissues are the umbilical cord and the placenta. After the baby is born, perinatal tissues are no longer needed by the mother’s or baby’s bodies. The vast majority of perinatal tissues are discarded as medical waste; however, these tissues are a potent source of cells that can be used to create life-saving therapies.

What are intended uses for OrganaBio products?

OrganaBio’s products are currently sold for preclinical research use only. OrganaBio’s cGMP products (slated to launch in late 2021) will be supported by quality and regulatory documentation for use in manufacturing of cell and cell-based therapeutics. OrganaBio’s products are not intended for direct use in humans or for in vitro diagnostic use. OrganaBio does not sell its products to any establishment claiming 361 regulation under the US FDA and will not do business with stem cell clinics or anyone suspected of not adhering to appropriate regulatory approval processes. OrganaBio may accept or reject any order for products in its sole discretion.

Do you only sell human cells?

Yes. OrganaBio is focused on speeding the development of cell and cell-based therapies. As such, our portfolio is comprised of human cells only. While our current products are for preclinical research use only, we are working towards offering cGMP cellular starting materials to speed clinical translation.

Do you sell embryonic stem cells?

No. OrganaBio only sells cells from postnatal tissues that are collected under approved Institutional Review Board (IRB) protocols and with the informed consent of non-compensated donors.

Do you fufill custom orders?

Since OrganaBio owns a properietary supply chain, we have the ability to work with customers to design and manufacture products and solutions that meet our customers’ unique needs. Please reach out to us at [email protected] to see how we can support your needs.

Can we purchase an entire product lot?

Subject to availability, full product lots may be purchased upon request. For more information, please reach out to our representatives at [email protected]

Do you offer donor matched cells from various tissues?

Our proprietary supply chain allows us to source donor-matched MSCs from placenta and cord, giving researchers the ability to determine if their results are tissue type and/or donor dependent. Additionally, OrganaBio offers researchers the ability to study possible combinatorial effects of MSCs with donor-matched HSCs and immune cells by offering these cells from the very same donor.

How are your cells different from other suppliers’ cells?

OrganaBio’s supply chain is proprietary and controlled by us, allowing us the ability to ensure quality every step of the way. Our cells are derived from fresh perinatal tissues isolated within hours of birth. In addition, we are able to offer donor-matched cells (i.e., multiple cell types derived from the same donor). Designed to support allogeneic therapy development, OrganaBio’s cells are also HLA typed, giving researchers the ability to test the effects of HLA matching or mismatching on cell persistence, immune response, and immune rejection.

In what formats do your cells come?

OrganaBio currently offers cryopreserved cells, vialed from 500,000 to 10 million cells per vial, depending on cell type. OrganaBio also offers test kits (cells + media), which allow researchers to economically test our product offerings and determine which donors’ cells/tissue of origin yield the intended results. Please contact us at [email protected] if there is an interest in having cells delivered in other formats, such as fresh cells, higher cell densities, or in bags.

How can I determine which donors’ cells are best for my application?

OrganaBio sources perinatal tissue from a diverse pool of donors. OrganaBio’s cell and media test kits allow researchers to economically test our product offerings. Recent studies have shown that donor and tissue source variability can affect functional outcomes. OrganaBio’s test kits allow researchers to sample our product offerings and determine which donors’ tissues of origin yield the intended results.

Are your cells derived from single donors or pooled donors?

OrganaBio’s products are designed to facilitate eventual tech transfer and clinical manufacturing. As such, our cell lots are always manufactured from a single donor. Given our high-efficiency bioprocess media system and robust MSC culture process, we (and subsequently our customers) are able to manufacture large lots of MSCs from a single donor, obviating the need to pool MSCs. The fetal origin of HSCs and immune cells contributes to unique hematopoiesis and maturation attributes, respectively, that vary between donors. Thus, we do not pool our HSCs or immune cells either. Our donor library allows our customers to screen multiple donors and cell lots to understand this donor-to-donor variability.