Cell BioEngines, Inc. announced an agreement with Miltenyi to develop and manufacture its expanded hematopoietic stem cell transplantation product for clinical use in hematology-oncology.
Cell BioEngines to Leverage Miltenyi’s Expertise and Proven Platforms to Develop and Manufacture Hematopoietic Stem Cell Transplantation (HSCT) Product
NEW YORK, Dec. 29, 2023 (GLOBE NEWSWIRE) -- 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.
Financial terms of the agreement were not disclosed.
About Cell BioEngines
Cell BioEngines, Inc., is a clinical-stage biotech company focused on developing ‘off-the-shelf’ allogenic cell therapies as ‘drugs’ to turn all cancers into curable diseases. The company leverages its proprietary Stem-SPACE™ platform technology to produce clinical-grade cells at economies of scale. The company’s versatile platform and pipeline allows them to pursue a broad range of cell and gene therapy product candidates in therapeutic areas of interest with high clinical and commercial potential.
About Miltenyi Biotec
Miltenyi Biotec is a global leader innovating products and services that empower biomedical research and advance cellular therapy. The company’s solutions support all stages of cell and gene therapy product development from process and analytical development to commercial-scale manufacturing. Its platform technologies have set industry standards in automated, integrated manufacturing and analysis of complex cellular products such as CAR-T cells, TCR-T cells, gene-modified NK and stem cells. Miltenyi Biotec’s comprehensive product portfolio is complemented by CDMO services for lentiviral vectors and cell manufacturing. The company has more than 4,700 employees in 23 countries and its products have been used in more than 100,000 cell therapy procedures.
Miltenyi Bioindustry, as a division of Miltenyi Biotec, uses its end-to-end expertise towards developing and manufacturing lentiviral vectors and cell and gene therapy products based on the CliniMACS Prodigy® fully automated cell manufacturing platform – from pre-clinical to commercial scale.
Contact
Mark Joubert., J.D.
Chief Legal Officer
Cell BioEngines, Inc.
info@cellbioengines.com
A photo accompanying this announcement is available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/6adcbc1f-87dd-42ad-a43d-e45935232982
Cell BioEngines Enters Manufacturing Agreement with Miltenyi Bioindustry
