BioIVT Introduces VivoSTART™ Cryopreserved GMP Leukopaks for Improved Cell Therapy Development

The high-quality, flexible, and regulatory-compliant cellular starting material will facilitate a smoother transition through preclinical and clinical development

WESTBURY, N.Y.--(BUSINESS WIRE)--BioIVT, a global research partner and biospecimen solutions provider for drug and diagnostic development, today announced the launch of VivoSTART™ Cryopreserved GMP Leukopaks. The GMP-compliant leukopaks ensure the quality, safety, and traceability of cellular starting material to support cell and gene therapy (CGT) platform process development and clinical trials. The addition to the company’s portfolio of human derived cellular starting materials emphasizes the commitment to supporting cell therapy development.

The Impact on Cell Therapy Innovation

With over 35 years of experience in biospecimen procurement to bring the best products to researchers in need – including its diverse donor pool consisting of over 600 recallable consented donors in the U.S. and U.K. – BioIVT continues to unlock the potential for its clients. With the global cell and gene therapy market exploding with a projection of $97 billion by 2033, the new offering is intended to enable smarter science and accelerate medical breakthroughs for researchers.

“BioIVT is proud to continue innovating by delivering trusted, reproducible, and reliable experimental results to our partners through consistent cell populations. Taking into account clients who require GMP-compliant cellular starting materials but may lack the capacity or resources to integrate fresh leukopaks into their development timelines, cryopreserved leukopaks offer the flexibility to allocate and schedule resources for downstream processing of leukapheresis material—ensuring client needs are met through our growing portfolio," said Dr. Parijat Jain, Vice President, Cell & Gene Therapy at BioIVT. “With comprehensive documentation—including detailed donor information, processing records, and quality control data—our partners can move forward with confidence in their decisions and the next step of their cell therapy journey.”

Building on the company’s unmatched portfolio, the VivoSTART Cryopreserved Leukopak is a distinct format within the VivoSTART category of BioIVT’s GMP-compliant products and current leukopak offerings, including last year’s introduction of LEUKOMAX XL. Combining high-quality starting cellular material, substantial target cell counts, and cryopreservation with regulatory oversight enables the progress of advanced therapies from development through manufacturing.

With enhanced regulatory oversight following cGMP guidelines, clients pursuing clinical phase development and downstream commercialization can feel confident in meeting their current and future market needs. Specifically, researchers have unmatched flexibility with the ability to process the leukopaks according to experimental timelines and resource availability, while also improving efficiency and reducing variability by receiving multiple leukopaks from the same donor and processing them in batches. For researchers facilitating collaboration across different research sites, the offering provides standardized and stable starting material that can be shipped and processed independently.

If you’re interested in learning more or exploring all of BioIVT’s leukopaks offerings, please visit www.bioivt.com.

About BioIVT

BioIVT enables smarter science and accelerates medical breakthroughs by delivering high-quality personalized biospecimen solutions and research services to the life science and diagnostic industries. We specialize in control and disease state samples including human and animal tissues or preparations, ADME products and research services, cell and gene therapy products, blood, and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in ELEVATING SCIENCE®. For more information, please visit www.bioivt.com or follow us on LinkedIn.