Minimize donor and process variability. Maximize reproducibility.
OrganaBio offers placenta-, umbilical cord-, and cord blood-derived progenitor and immune cells, in a variety of formats. Supported by QA and regulatory documentation, our cell products are ready for IND-enabling studies and facilitate clinical translation.
OrganaBio owns and controls the majority of its manufacturing supply chain, thereby ensuring consistent quality throughout the manufacturing process. OrganaBio consents donors, collects the tissues, manufactures (isolates and expands) cells, characterizes the cells, vials, packages and delivers high-quality product to our customers.
OrganaBio has access to a racially-diverse donor pool, meaning our customers have access to a library of diverse donors. Given our extensive cell characterization, customers can choose donors and cell lots based on critical quality attributes that best suit their specific needs.
OrganaBio’s perinatal tissues are ethically sourced from fully-consented, non-compensated, full-term c-section births and collected under an IRB-approved protocol.
Our proprietary supply chain allows us to manufacture donor-matched MSCs, HSCs, and immune cells from placenta, umbilical cord, and cord blood, allowing researchers to interrogate whether tissue of origin impacts functional outcomes in the absence of donor variability.
Designed for allogeneic cell and gene therapy development, OrganaBio’s cell-based products are HLA typed, giving researchers the ability to test the effects of HLA matching or mismatching on cell persistence, immune response, and immune rejection.
OrganaBio’s products are manufactured with clinical translation in mind. Our focus on quality will facilitate our customers’ tech transfer to clinical manufacturing.
Off-the-shelf, cGMP cellular raw materials are slated to launch in Q4 2021.