MIAMI--(BUSINESS WIRE)--OrganaBio, LLC (“OrganaBio”) announces the launch of adult peripheral blood-derived products, including vialed peripheral blood mononuclear cells (PBMCs) and whole leukopaks (LeukoPAC™). These products contain high concentrations of PBMCs, such as T cells, NK cells, B cells and monocytes, which are critical raw materials for immunotherapy research and allogeneic cell therapy development and manufacturing. OrganaBio’s unique supply chain and manufacturing capabilities enable it to process PBMCs within hours of collection to ensure delivery of high-quality starting material to researchers and therapeutics developers.
The new leukapheresis-derived products portfolio is obtained from consented, compensated donors under IRB-approved protocols. Donor recruitment and leukapheresis collections are conducted by OrganaBio’s wholly-owned subsidiary, HemaCenter, LLC. Collection procedures are performed on the FDA-approved Terumo Spectra Optia, by Registered Apheresis Nurses under the supervision of a board-certified Medical Director. OrganaBio’s diverse donor pool consists of carefully screened individuals who undergo testing which includes infectious disease and hematology assessments. “OrganaBio has quickly developed a robust database of genotyped and immunophenotyped, pre-screened, qualified, and reliable donors. OrganaBio’s newly added adult-derived LeukoPAC™ and PBMC products from a large and diverse donor pool will fill the industry’s unmet needs,” said Mr. Justin Irizarry, CEO.
HLA typing and demographic information is provided to inform donor selection. OrganaBio’s PBMCs and LeukoPACs are also supported by a comprehensive data package elucidating donor attributes, purity, cell viability, and comprehensive immunophenotyping profile. LeukoPACs are available in a range of volumes and formats, and various donor characteristics and testing options are offered “a-la-carte”, to allow customers to only pay for the customization that they require. “Leukapheresis-derived cells are used by medical researchers to explore novel ways to prime the immune system against cancer and other diseases. It is our hope that, by providing high quality immune cells that are well-characterized and that meet therapeutics developers’ specifications, we will contribute to more rapid allogeneic immunotherapy development, thereby saving lives,” said Dr. Priya Baraniak, Vice President of Corporate Development and Process and Product Development lead for OrganaBio.
The addition of adult blood-derived products to OrganaBio’s portfolio of perinatal tissue- and blood-derived cell products and media systems furthers OrganaBio’s mission to provide critical cellular raw materials that are not readily accessible to cell therapy developers. Immunotherapy is a promising treatment against blood cancers such as leukemia and lymphoma, and solid tumors, which require high quantity and quality of starting material. “OrganaBio’s cell products 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-client 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 www.hemacenter.com and follow us on LinkedIn and twitter (@organabio/@hemacenter).
