Cell BioEngines and Miltenyi Partner To Develop Transplantation | India Pharma Outlook

Cell BioEngines and Miltenyi Partner To Develop Transplantation

India Pharma Outlook Team | Saturday, 30 December 2023

 India Pharma Outlook Team

A collaboration with Miltenyi has been announced to develop and produce Cell BioEngines, Inc.'s expanded hematopoietic stem cell transplantation (HSCT) product for clinical use in hematology-oncology. Cell BioEngines, Inc. is a clinical-stage biotechnology company focused on delivering novel, innovative stem cell and immune cell therapies to address blood and solid cancers.

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, as per  Cell BioEngines.

Miltenyi will undertake development leading to Good manufacture Practices (GMP) manufacture of Cell BioEngines' CBE-101 clinical trial batches under the conditions of the agreement. "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.

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