SOUTH MIAMI, Fla.--(BUSINESS WIRE)--OrganaBio, LLC, announces the opening of a new laboratory facility in Irvine, California, further expanding its reach and capabilities from the southeast to the west coast. The new facility will offer support services to clinical trial sponsors and CROs, including patient sample processing, analytical testing, cryopreservation, and storage.
OrganaBio currently offers a host of cell processing and analytical testing services to support clinical studies, including the isolation and cryopreservation of PBMCs and other cells from whole blood. During the past 12 months, the OrganaBio team successfully processed over 750 clinical samples from 9 clinical sites in South Florida, associated with 8 different studies and programs for several large pharmaceutical partners. The co-localization of OrganaBio’s cell processing labs to clinical sites allows for sample delivery and process initiation within hours of patient sample receipt. In 2022, the OrganaBio team averaged 76 minutes from blood sample receipt to initiation of cell processing activities, yielding results with greater data integrity for the clinical trial sponsor. Given the tremendous response of its current sponsors, OrganaBio plans to open additional new sample processing sites in other locales, beginning with the current expansion to Southern California.
The new Irvine facility will leverage OrganaBio’s advanced cell isolation, characterization, and cryopreservation techniques currently used to successfully collect and process patients’ samples. State of the art storage systems will be utilized for optimal sample preservation and long-term storage. In order to ensure data integrity and traceability, advanced information management systems will be employed to track and access the clients’ tissue and cell samples.
OrganaBio is a fast-moving, flexible CTDMO, providing tightly integrated tissue and cellular products and manufacturing solutions to catalyze clinical translation of innovative cell and gene therapies. Through its wholly owned, FDA-registered subsidiaries, HemaCenter and GaiaGift, OrganaBio provides adult apheresis-derived and birth-tissue derived products to cell therapy developers. This portfolio includes off-the-shelf cells (HSCs, PBMCS, NK cells, T cells, etc) and tissues (cord blood units and leukopaks) with adequate room for customization to meet any program’s needs. OrganaBio upholds the highest standards of ethics and quality in all operations. All perinatal tissues and apheresis materials are ethically sourced, and donors are screened and consented under IRB-approved protocols. Additionally, donor eligibility and testing are determined according to US FDA 21 CFR 1271 requirements.
While OrganaBio has been providing cell therapy developers with tissues and cells for research and process development since 2020, the geographic expansion of the clinical trial support services business allows the company to provide patient sample processing capabilities to CROs and clinical trial sponsors across the country. OrganaBio’s new facility will accelerate clinical translation of cell therapies and vaccines, delivering lifesaving and life-altering therapies to patients. For more information on OrganaBio products or services, please contact Dr. Priya Baraniak, Chief Business Officer at priya@organabio.com.
