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Cell BioEngines to Leverage Miltenyi’s Experience and Confirmed 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 firm centered on delivering novel, revolutionary stem cell and immune cell therapies to handle blood and strong cancers, at this time introduced an settlement with Miltenyi to develop and manufacture its expanded hematopoietic stem cell transplantation (HSCT) product for scientific use in hematology-oncology.
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Cell BioEngines’ proprietary stem cell enlargement expertise gives an ‘off-the-shelf’ healing therapy for blood most cancers sufferers who want a bone marrow transplant. It makes use of a patented small molecule to extend the variety of hematopoietic stem cells derived from umbilical cord-blood whereas sustaining stemness to handle the donor availability for allogenic HSCT.
Beneath the phrases of the settlement, Miltenyi will start growth main in the direction of Good Manufacturing Practices (GMP) manufacturing of the Part 1 scientific trial batches of Cell BioEngines’ CBE-101 scientific program. “Working with Miltenyi permits us to keep away from the necessity to make investments time, sources and capital in establishing our personal CMC growth and manufacturing capabilities. This permits us to pay attention all our efforts on the essential job of creating and advancing safer, more practical stem cell most cancers therapies for sufferers,” stated Dr. Ajay Vishwakarma, MBA, Founder and CEO, Cell BioEngines, Inc.
“HSC therapies are notably nicely supported by way of integration of Miltenyi’s proprietary platforms for cell processing and cell evaluation, pre-sterilized single use disposables, in addition to Miltenyi’s best-in-class GMP-quality cell isolation, activation, and tradition system reagents. Specifically, the CliniMACS Prodigy® platform has been developed as an optimized, clinic-ready platform for HSC isolation, transduction, and enlargement inside a closed, automated system, and for larger-scale allogeneic cell manufacturing processes, Miltenyi has expertise in integrating the CliniMACS Prodigy® with third-party bioreactors to scale up cell remedy manufacturing processes,” stated Leonard Pulig President and GM, Miltenyi Biotec, Inc.
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“Miltenyi’s experience in cell remedy course of growth, product scale-up, along with accessing state-of-the-art high quality programs assembly all US GMP requirements for cell remedy merchandise makes them an ideal match for GMP manufacturing of Cell BioEngines first scientific product candidate,” stated Alexey Bersenev, MD, PhD, Co-founder and CTO of Cell BioEngines, Inc.
Monetary phrases of the settlement weren’t disclosed.
About Cell BioEngines
Cell BioEngines, Inc., is a clinical-stage biotech firm centered on creating ‘off-the-shelf’ allogenic cell therapies as ‘medicine’ to show all cancers into curable illnesses. The corporate leverages its proprietary Stem-SPACE™ platform expertise to provide clinical-grade cells at economies of scale. The corporate’s versatile platform and pipeline permits them to pursue a broad vary of cell and gene remedy product candidates in therapeutic areas of curiosity with excessive scientific and industrial potential.
About Miltenyi Biotec
Miltenyi Biotec is a worldwide chief innovating services and products that empower biomedical analysis and advance mobile remedy. The corporate’s options help all phases of cell and gene remedy product growth from course of and analytical growth to commercial-scale manufacturing. Its platform applied sciences have set business requirements in automated, built-in manufacturing and evaluation of complicated mobile merchandise equivalent to CAR-T cells, TCR-T cells, gene-modified NK and stem cells. Miltenyi Biotec’s complete product portfolio is complemented by CDMO providers for lentiviral vectors and cell manufacturing. The corporate has greater than 4,700 workers in 23 international locations and its merchandise have been utilized in greater than 100,000 cell remedy procedures.
Miltenyi Bioindustry, as a division of Miltenyi Biotec, makes use of its end-to-end experience in the direction of creating and manufacturing lentiviral vectors and cell and gene remedy merchandise primarily based on the CliniMACS Prodigy® absolutely automated cell manufacturing platform – from pre-clinical to industrial scale.
Contact
Mark Joubert., J.D.
Chief Authorized Officer
Cell BioEngines, Inc.
data@cellbioengines.com
A photograph accompanying this announcement is offered at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/6adcbc1f-87dd-42ad-a43d-e45935232982
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