Discovery Life Sciences streamlines cell and gene therapy manufacturing with expanded human cellular starting materials

Huntsville’s Discovery Life Sciences™, specialists in biospecimen and biomarker technology, announced the expansion of its GMP-compliant, clinical-grade product portfolio with the launch of Discovery Cryo LeukopaksTM (RUO).

The company’s extended capabilities around GMP-compliant cellular starting materials will ease logistical challenges for therapeutic developers and manufacturers by streamlining the transition from research to manufacturing of next-generation cell and gene therapies.

Discovery is committed to accelerating the development and successful clinical translation of cell and gene therapies, which are revolutionizing treatment approaches to cancer and other complex diseases. Doing so requires rapid, reliable access to high-quality, well-characterized human cellular starting materials that Discovery is uniquely positioned to provide to researchers and manufacturers worldwide.

“The right GMP-compliant cryopreservation products are critical for providing the industry with the clinical material needed to expedite the transition from R&D to commercialization,” said Dominic Clarke, Ph.D. and chief technical officer of Cell and Gene Therapy at Discovery Life Sciences. “Discovery now offers industry-leading, reliable cryopreserved leukopaks that are needed to support research and GMP-compliant manufacturing. Cell therapy developers who partner with Discovery will be able to simplify and accelerate their manufacturing processes while trusting the quality and support Discovery provides to scientists worldwide.”

Discovery Cryo Leukopaks (RUO) are manufactured from the peripheral blood of human donors at the Discovery’s U.S. Donor Center. They are frozen quickly after collection using a controlled rate method to maximize viability.

Each RUO consists of a concentrated fraction of mononuclear cells that include B cells, T cells, NK cells, Dendritic cells, monocytes and CD34+. They are obtained using IRB-approved consent forms and protocols. Each donor is tested for HIV, HBV, HCV, and CMV, and HLA typed via 6-digit NGS.

Discovery has optimized and controlled cryopreservation protocols to achieve high-quality performance specifications that support GMP-compliant manufacturing requirements and allow cell and gene therapy developers to seamlessly transition their advanced therapy processes.

Combined with Discovery’s isolated immune cells, diseased human biospecimens, and multi-omic biomarker service capabilities, Discovery’s cell and gene therapy portfolio offers researchers and manufacturers a unique, integrated solution to streamline the advancement of new therapies from early research through to clinical manufacturing.

Driven by leading scientific expertise and innovative use of current technologies, the Discovery team engages and consults with customers to overcome obstacles more rapidly and obtain results to make critical research, development, and manufacturing decisions at market-leading speed.