MIAMI–(BUSINESS WIRE)–#CART–OrganaBio, LLC (“OrganaBio”) announces the launch of the ImmunoPAC™-T-CB T cell product, designed to support development of allogeneic immune cell-based therapies, such as CAR-T. These products provide a unique and timely solution to critical supply chain issues that are hindering the cell therapy, gene therapy, and immunotherapy industries.
ImmunoPAC-T-CB T cells are derived from full-term umbilical cord blood obtained from consented, non-compensated donors under IRB approved protocols. “Cell and gene therapy developers have endured manufacturing setbacks due to supply chain bottlenecks in the industry. By providing high-quality starting raw materials, OrganaBio facilitates successful clinical translation of innovative therapies,” said Mr. Justin Irizarry, CEO.
Via its proprietary supply chain, OrganaBio manufactures ImmunoPAC-T-CB T cells from fresh cord blood, within hours of birth. The T cells are negatively selected and demonstrate high purity and viability. In addition, all donors are HLA typed to provide relevant genetic information that our customers can use to inform their preclinical testing. ImmunoPAC-T-CB T cells are also supported by a comprehensive quality data package elucidating donor attributes, viability, purity, and immunophenotyping profile for each cell lot manufactured. Part of the ImmunoPAC product line, ImmunoPAC-T-CB T cells can be matched with ImmunoPAC-NK-CB Natural Killer (NK) cells and other cell products, such as MesenPAC™-MSCs, from several perinatal tissues derived from the same donor, eliminating donor variability in experimental protocols.
“The cord blood is a rich source of naive, immature lymphocytes for immune cell therapies,” said Dr. Priya Baraniak, Vice President of Corporate Development and Process and Product Development lead for OrganaBio. “The increased proliferative capacity and potency of cord blood-derived immune cells, coupled with less stringent HLA matching requirements, makes these cells an attractive starting material for allogeneic cell therapy development. We look forward to rapidly bringing additional immune and stem cell products (including hematopoietic stem cells (HSCs) and B cells) that the industry urgently needs for development of allogeneic therapies to market in the coming months.”
With the addition of ImmunoPAC-T-CB T cell product, OrganaBio is expanding its ImmunoPAC product line and contributing to the acceleration of the growing field of cellular based immunotherapies. (Read more…) “OrganaBio provides therapeutic developers with solutions that fit their process and product development needs. Our cell portfolio, coupled with our ability to soon manufacture cGMP product in our facility (opening Q3 2021) will help rapidly move allogeneic cell products into the clinic,” said Justin Irizarry.
ABOUT ORGANABIO
OrganaBio, LLC is a privately held solutions provider for the cell, gene, and immunotherapy fields. OrganaBio has a proprietary supply chain of perinatal tissue (including cord blood and cord tissue) from non-compensated donors 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).
Contacts
Dr. Priya Baraniak
Vice President, Corporate Development
priya@organabio.com
(786) 656-0107