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Press Release
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IB Communications
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OrganaBio expands California CPC Services hub for sample processing and cryopreservation capabilities to support Big Pharma clinical trials
- OrganaBio working with two large-cap pharmaceutical companies on clinical trials for respiratory disease vaccine
- Cell Processing and Cryopreservation (CPC) Services’ straightforward expansion in Irvine, California used project at Miami site as a template, made possible through robust eQMS
Miami, Florida, June 05, 2024 – OrganaBio, the cell and gene therapy industry’s hub for tissue sourcing, cell isolation, cryopreservation, contract manufacturing services and clinical sample processing, today announced the expansion of its flagship Cell Processing and Cryopreservation (CPC) Services hub in Irvine, California to support clinical trial services for a large-cap pharmaceutical company. The expansion comes a year after opening the Irvine lab and just months after the October launch of OrganaBio’s CPC Services division.
The Irvine facility already services 7 major clinical trial cities in the region, offering services like peripheral blood mononuclear cell (PBMC) isolation and cryopreservation, as well as storage, logistics, and batch shipping on request. As its pharmaceutical partner looked to add a new site in the region for an existing clinical trial, CPC Services quickly and simply duplicated activities performed at its Miami-based location. The rapid expansion was enabled by OrganaBio’s electronic Quality Management System that enables unified training, tech transfer and SOPs, as well as equipment and operator qualifications.
“Through CPC Services, we’ve developed a quick and flexible approach to bicoastal trial expansion,” said Priya Baraniak, Ph.D., Chief Business Officer of OrganaBio. “In the last two years working with two multinational large-cap pharmaceutical companies, as well as other trial sponsors, we have developed an unparalleled reputation for quality. This includes a 99.9% success rate handling 2,000 samples, processing them in half the time required and leading the industry with 99.1% PBMC viability.”
Expanded CPC Services are already operational at the Irvine facility, and able to support trials at sites in Los Angeles, San Diego, Las Vegas, Phoenix, Tucson, San Jose, San Francisco, and more. In addition to the Miami and Irvine sites, CPC Services will soon expand to locations in Chicago, Nashville, Ann Arbor and Atlanta, enabling high-quality and fast trial support across the U.S. For more information, visit https://www.cpcservices.com/.
Visit OrganaBio this week in San Diego at the 2024 BIO International Convention – Booth #2625
About OrganaBio
OrganaBio is a robust and reliable biotech solutions provider for cell therapy and immunotherapy developers. The company has pioneered a new paradigm for ethically accelerating the deployment of cell therapies, making accessible critical resources that are essential for therapeutics development and marrying this to manufacturing capabilities. OrganaBio spans the full development lifecycle – from proprietary tissue supply chains and cellular starting materials to expert support services including development and testing. Its state-of-the-art, ready-to-use cGMP manufacturing facility supports the rapid, economical, and ethical manufacture of clinical materials from birth tissues, apheresis products, and their components (including HSCs, PBMCs, NK cells, T cells, and subsets of these cells).
Strategic partnerships are needed to accelerate advanced therapies from the lab to global commercialization. OrganaBio’s flexibility and agility allows partners to significantly reduce manufacturing cost and timelines, with best-in-class donor management practices and tissue collection facilities. OrganaBio sources donor tissues under fully consented institutional review board (IRB)-approved protocols, and in accordance with US FDA standards. More about OrganaBio can be found at www.organabio.com.
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