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

Cell BioEngines’ proprietary stem cell expansion technology provides an ‘off-the-shelf’ curative treatment for blood cancer patients who need a bone marrow transplant. It uses a patented 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.

Under the terms of the agreement, Miltenyi will begin development leading towards Good Manufacturing Practices (GMP) manufacturing of the 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 Dr. Ajay Vishwakarma, MBA, 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. 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," said Leonard Pulig President and GM, Miltenyi Biotec, Inc. 

"Miltenyi's expertise in cell therapy process development, product scale-up, in addition to accessing state-of-the-art quality systems meeting all US GMP standards for cell therapy products makes them a perfect fit for GMP manufacturing of Cell BioEngines first clinical product candidate," said Alexey Bersenev, MD, PhD, Co-founder and CTO of Cell BioEngines, Inc.