Cell BioEngines, Inc., a clinical-stage biotechnology company focused on delivering stem cell and immune cell therapies to address blood and solid cancers, entered into an agreement with Miltenyi to develop and manufacture its expanded hematopoietic stem cell transplantation (HSCT) product for clinical use in hematology-oncology.

Cell BioEngines’ stem cell expansion technology provides an ‘off-the-shelf’ treatment for blood cancer patients who need a bone marrow transplant. It uses a small molecule to increase the number of hematopoietic stem cells derived from umbilical cord-blood while maintaining stemness to address the donor availability for allogenic HSCT.

Miltenyi will begin development leading towards GMP manufacture of Phase 1 clinical trial batches of Cell BioEngines’ CBE-101 clinical program.

“Working with Miltenyi enables us to avoid the need to invest time, resources and capital in constructing our own CMC development and manufacturing capabilities. This allows us to concentrate all our efforts on the crucial task of developing and advancing safer, more effective stem cell cancer treatments for patients,” said Ajay Vishwakarma,Founder and CEO, Cell BioEngines, Inc.

“HSC therapies are particularly well supported through integration of Miltenyi’s proprietary platforms for cell processing and cell analysis, pre-sterilized single use disposables, as well as Miltenyi’s best-in-class GMP-quality cell isolation, activation, and culture system reagents,” said Leonard Pulig president and general manager, Miltenyi Biotec, Inc. “In particular, the CliniMACS Prodigy platform has been developed as an optimized, clinic-ready platform for HSC isolation, transduction, and expansion within a closed, automated system, and for larger-scale allogeneic cell manufacturing processes, Miltenyi has experience in integrating the CliniMACS Prodigy with third-party bioreactors to scale up cell therapy manufacturing processes.”