MIAMI--(BUSINESS WIRE)--OrganaBio, LLC (“OrganaBio”) announces the launch of the HematoPAC™-HSC-CB CD34+ hematopoietic stem cell (HSC) product, designed to support development of HSC-based allogeneic cell therapies. These products provide a unique and timely solution to COVID-19 induced supply chain shortages that are hindering the cell therapy and immunotherapy industries.
HematoPAC-HSC-CB cells are derived from full-term umbilical cord blood obtained from consented, non-compensated donors under IRB approved protocols. “Umbilical cord blood is a rich source of CD34+ HSCs for HSC transplantation and other HSC-based cell therapies. Despite this, the vast majority of cord blood is thrown away as medical waste because banking is not viable. OrganaBio collects this cord blood to isolate HSCs and other immune cells that can be used by cell therapy developers as starting materials for the development of life saving therapies,” said Mr. Justin Irizarry, CEO.
Via its proprietary supply chain, OrganaBio manufactures HematoPAC-HSC-CB from fresh cord blood, within hours of birth. The HSCs are positively selected and demonstrate high purity and viability. In addition, all donors are HLA typed, and genotype and demographic information is provided to inform donor selection. HematoPAC-HSC-CB are also supported by a comprehensive data package elucidating donor attributes, viability, purity, and immunophenotyping profile for each cell lot manufactured. Derived from a single cord blood unit, HematoPAC-HSC-CB can be matched ImmunoPAC-T-CB T cells, ImmunoPAC-NK-CB Natural Killer (NK) cells and even MesenPAC™-MSCs from tissues derived from the same donor, eliminating donor variability in experimental protocols. Furthermore, this unique product portfolio allows for cells to be HLA and KIR mismatched to investigate the effects of mismatching on preclinical and future clinical outcomes.
“HSCs are a versatile cell type that can be differentiated into the various constituents of the blood and immune systems and are also an attractive starting population for induced pluripotent stem cell (iPSC) generation,” said Dr. Priya Baraniak, Vice President of Corporate Development and Process and Product Development lead for OrganaBio. “The increased proliferative capacity and multilineage differentiation potential of cord blood-derived HSCs, coupled with less stringent HLA matching requirements (as compared to adult tissue-derived HSCs) renders these cells suitable for allogeneic cell therapy development, including HSC-derived CAR-T and CAR-NK therapies. OrganaBio’s unique ability to isolate HSCs from a fresh cord blood unit (i.e., non-cryopreserved) ensures the highest quality of the cells and gives therapeutic developers the ability to test the potency of fresh vs. frozen HSCs in their workflow. We look forward to further rounding out our portfolio of tools and solutions for cell therapy and immunotherapy developers with the opening of our leukapheresis center in April and our cGMP manufacturing facility later this year.”
The addition of the HematoPAC-HSC-CB product furthers OrganaBio’s mission to provide critical resources that are not readily accessible to cell therapy developers. “OrganaBio provides therapeutic developers with solutions that fit their process and product development needs. Pre-isolated, fully characterized cells reduce the upfront time and cost associated with donor recruitment and management and tissue processing and allow therapeutic developers to start with a well-defined and consistent product. Our cell portfolio, coupled with our ability to soon manufacture cGMP product in our facility will help rapidly move our customers’ allogeneic cell products into the clinic,” said Justin Irizarry.
ABOUT ORGANABIO
OrganaBio, LLC is a privately held solutions provider for the cell therapy and immunotherapy fields. OrganaBio has a proprietary tissue supply chain of perinatal and adult tissues and offers a range of starting cellular materials from these tissues. OrganaBio manufactures off-the-shelf research grade products for allogeneic cell therapy development and is building cGMP manufacturing capabilities, with a forecasted launch in Q3 2021. OrganaBio’s state-of-the-art, multi-tenant cGMP facility will not only be used to manufacture the company’s cellular raw materials for therapeutics development but will also offer the industry cleanrooms and support services to rapidly manufacture clinical materials. This new paradigm in cGMP manufacturing affords companies flexibility and agility, significantly reducing manufacturing costs and timelines. For more information, visit www.organabio.com and follow the company on LinkedIn and twitter (@organabio).
