Also announces installation of Asymptote VIA Quad Freeze controlled-rate freezer
MEMPHIS, TN, and MONTREAL QC, May 14, 2018 – Key Biologics LLC , a provider of biological raw materials and services for manufacturing cell-based therapeutics, today announced the availability of fresh and frozen whole leukaphereses from patients with hematologic malignancies; Multiple Myeloma, Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia and Acute Lymphocytic Leukemia. These malignancies are important targets for CAR-T therapies being developed by many companies worldwide. Access to the disease-state products will provide researchers with viable and representative patient material before entering Phase I studies so their early work with process development and proof of concept can more closely mimic the targeted applications.
The announcement was made at ISCT (International Society for Cell Therapy) 2018 in Montreal where Key Biologics is a Gold Sponsor.
The new disease-state collections will be performed under an IRB-approved protocol in a similar manner to Key Biologics’ collections of ‘Leukopaks’ from both non-mobilized and G-CSF mobilized normal healthy donors screened in accordance with FDA requirements of donors of transfusible products. Those non-mobilized normal donor products are intended for pre-clinical use. The G-CSF mobilized normal donor products are intended for both pre-clinical use and commercial development and clinical use.
At the ISCT event, Key Biologics also announced the installation of its new Asymptote VIA Freeze™ Quad controlled-rate freezer. The Quad allows freezing of whole leukapheresis products, up to 270mL, or up to 192 cryovials. Many CAR-T companies are planning for patient raw material collected for clinical trials or manufacturing to be frozen at the site of the collection. With the new Asymptote freezer, Key Biologics can now provide raw materials that are collected from individuals with targeted diseases and front-end processed in a manner that mimics what the company expects to use for its clinical trials. These types of products, when available early in development, allow more representative challenges to the final manufacturing process and allow adjustments to be made prior to initiation of clinical trials.
“We’re very pleased to announce the availability of these new offerings that will help accelerate our clients’ important research efforts in cellular therapy,” said Dr. Edward Scott, president of Key Biologics LLC. “Both are important parts of our strategy to improve research output by providing continuity of source from pre-clinical research through all phases of clinical trials and into post-market commercial production. We will continue to expand our capabilities to deliver on this strategy.”
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