Pharma Focus Europe

Cell BioEngines and Miltenyi Bioindustry Establish Collaboration for Manufacturing Hematopoietic Cell Therapy in Clinical Program

Tuesday, January 02, 2024

Cell BioEngines, Inc., a biotechnology company in the clinical stage, has revealed a partnership with Miltenyi to progress the development and manufacturing of its expanded hematopoietic stem cell transplantation (HSCT) product for clinical use in hematology-oncology. The company's stem cell expansion technology, utilizing a patented small molecule, aims to provide a readily available curative treatment for blood cancer patients requiring a bone marrow transplant. This collaboration involves Miltenyi undertaking development leading to Good Manufacturing Practices (GMP) manufacturing of Phase 1 clinical trial batches for Cell BioEngines' CBE-101 clinical program.

Dr. Ajay Vishwakarma, Founder and CEO of Cell BioEngines, Inc., expressed the strategic advantage of working with Miltenyi, stating that it allows the company to focus on developing safer and more effective stem cell cancer treatments without the need to invest in building their own development and manufacturing capabilities.

Leonard Pulig, President and GM of Miltenyi, emphasized the synergy between Miltenyi's proprietary platforms and Cell BioEngines' HSCT therapies. The CliniMACS Prodigy® platform, in particular, is highlighted for its optimized, clinic-ready features for hematopoietic stem cell (HSC) isolation, transduction, and expansion within an automated system. Miltenyi's experience in integrating the CliniMACS Prodigy® with third-party bioreactors for larger-scale allogeneic cell manufacturing processes adds value to the collaboration.

Alexey Bersenev, Co-founder and CTO of Cell BioEngines, Inc., highlighted Miltenyi's expertise in cell therapy process development, product scale-up, and adherence to quality systems meeting US GMP standards. This expertise positions Miltenyi as an ideal partner for the GMP manufacturing of Cell BioEngines' first clinical product candidate.




Thermo Fisher Scientific - mRNA ServicesWorld Orphan Drug Congress 2024World Vaccine Congress Europe 2024Advanced Therapies USA 2024