BioIVT, a leading provider of biospecimens, research models and services for drug and diagnostic development announced the launch of its Good Manufacturing Practice (GMP-) grade VivoSTART leukopaks. Leukopaks contain concentrated white blood cells and are used to research and manufacture cell and gene therapies.
“This GMP-grade leukopak product introduction underscores BioIVT’s commitment to being a high quality, global immune cell provider,” said BioIVT CEO Dr. Richard Haigh. “BioIVT customers have always been able to scale their research up and out using our global collection network of recallable donors. With the VivoSTART leukopak launch, our customers can now transition seamlessly from research to manufacturing without compromising product integrity.”
GMP-compliant VivoSTART leukopaks will serve as the ideal starting material for allogeneic ex vivo cell therapies and other advanced therapeutic applications. BioIVT’s immune cell experts will work with customers to validate donors based on specific demographic criteria, HLA-type, or Fc receptor type, or other desired specifications. BioIVT also offers supply chain security solutions, such as reserving cells from specific donors for specific projects.
Matt Chorley, VP of Quality at BioIVT, explained: “As allogeneic cell and gene therapies continue to show promise, their successful clinical development begins with choosing a vendor for their starting material. Each therapy is unique, so our goal is to work not only as a starting material vendor, but also a quality partner and develop quality specifications that work in their individual research programs.”
BioIVT’s VivoSTART leukopak product line is supported by its FDA-registered collection site in Johnson City, Tennessee which meets all applicable US GMP/GTP standards (21 CFR 606, 1271 and 21 CFR part 11 and part 58). BioIVT’s GMP leukopaks also comply with all documented sourcing, handling, processing, storage, preserving, packaging, and product distribution procedures.