MIAMI– OrganaBio, LLC, announces initiation of GMP manufacturing operations at its new cell therapy manufacturing facility, launching a new paradigm in contract and development manufacturing. Acknowledging the need for custom solutions for therapeutics developers, the company will not only leverage its tissue supply chains to manufacture clinical grade tissue and cellular raw materials derived from perinatal tissues and adult apheresis products for partners, but will also offer contract-, self-, and hybrid-manufacturing options within the facility.
OrganaBio upholds the highest standards of ethics and quality in all operations. All perinatal tissues and apheresis materials are ethically-sourced through two OrganaBio wholly-owned subsidiaries which are US FDA registered blood and tissue establishments. All donors are screened and consented using IRB-approved protocols and donor eligibility and testing determined according to 21 CFR 1271 requirements.
OrganaBio’s product portfolio includes umbilical cord blood (UCB) and UCB-derived CD34+ hematopoietic stem cells (HSCs), Natural Killer (NK) cells, and T cells. In addition, OrganaBio manufactures leukopaks and peripheral blood-derived mononuclear cells (PBMCs), NK cells, and T cells from healthy, adult donors. Rounding out the product portfolio are mesenchymal stromal cells (MSCs) derived from placenta and umbilical cord tissues. Leveraging its proprietary tissue supply chains, the experienced OrganaBio team also routinely performs custom cell isolations, assay development, and analytical testing for customers. While OrganaBio has been providing cell therapy developers with tissues and cells for preclinical research use since 2020, the addition of GMP manufacturing capabilities now allows the company to provide analogous clinical grade cellular starting materials to drive successful technology transfer and clinical manufacturing of cell-based drug products for clinical trials. All products are accompanied by Certificates of Analyses and supplemental quality and compliance documentation.
While access to clinically relevant tissues and cells alleviates one bottleneck in cell therapy, immunotherapy, and regenerative medicine, expeditious access to and availability of GMP manufacturing space is another limitation that continues to hinder industry progress. To address this critical constraint, OrganaBio offers flexible manufacturing solutions within its manufacturing facility. Use of OrganaBio’s facility provides access to advanced process development suites, ISO 7 certified cleanrooms, and an on-site analytical testing core all equipped with qualified scientific equipment. In addition, OrganaBio provides a host of consulting and support services (including Quality Assurance, Compliance and Regulatory, assay development, materials receipt, inventory management, ambient and cold storage solutions, environmental monitoring, and facilities maintenance) needed for GMP compliant manufacturing. Customers may engage OrganaBio’s expert staff to manufacture their cell therapy products in the traditional contract manufacturing sense, or they may retain control of their process by self-manufacturing in a cleanroom on-site. The self-manufacturing option allows clients to manufacture product utilizing their own team members and procedures, eliminating the need for lengthy technology transfer and sharing of proprietary information and intellectual property. Since neither of the aforementioned models may be the right fit for a manufacturing program, OrganaBio also offers hybrid manufacturing wherein experts from the developer’s and OrganaBio’s teams work alongside one another to manufacture product.
“Since our inception in 2018, OrganaBio has been focused on providing solutions that accelerate the rate at which cell therapy developers can manufacture life saving drugs. Our conversations with customers and partners have revealed that GMP manufacturing space, available immediately, and with flexibility to allow developers to manufacture their drugs alongside OrganaBio’s professionals, is extremely valuable,” said Justin Irizarry, CEO of OrganaBio. “When combined with OrganaBio’s quality assurance, regulatory, compliance, and assay development services, OrganaBio provides a well integrated manufacturing solution that affords speed and control to cell therapy developers.”
