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Andelyn AAV Curator Platform used to manufacture clinical grade viral vector for US FDA-authorized first-in-world universal donor CRISPR/AAV transduced CAR-NK cells

Columbus, Ohio
Thursday, May 8, 2025, 15:00 Hrs  [IST]

Andelyn Biosciences, Inc., a leading and patient-focused cell and gene therapy contract development and manufacturing organization (CDMO), has manufactured viral vector with its AAV Curator Platform for the Nationwide Children’s Hospital’s Cellular Therapy and Cancer Immunology Programme. The Adeno-Associated Virus (AAV) will be utilized in a novel cell therapy for Universal-Donor CD38KO CD33CAR-NK cells, to be studied in a forthcoming clinical trial. The phase 1 trial will study the safety of the novel therapy in patients with advanced, high-risk acute myeloid leukaemia (AML).

Within the field of cell therapy, there is a consistent need from researchers to manufacture cGMP virus to support the advancements of these critical therapies.  While many AAV manufacturing platforms are specifically designed to be scaled to support large scale indications, Andelyn’s AAV Curator Platform utilizes Optimization-by-Design to be correctly sized for scale and speed to the clinic. The well-established platform allows for the ability to support the exacting viral vector manufacturing needs of the NCH NK cells created on the hospital’s patented universal-donor NK cell platform.

Matt Niloff, chief commercial officer at Andelyn, said, “we are excited to be playing a key role in this very promising Universal Donor CD38KO CD33CAR-NK cell therapy technology by NCH. We look forward to the clinical trial ushering in a new era for patients with AML and other blood cancers.”

Andelyn is enabling the progression of life-altering cell and gene therapies for both rare and prevalent diseases with the highest quality standards and scalable end-to-end development and manufacturing capabilities at its Columbus, Ohio facilities.

Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on the development, characterization and production of viral vectors for gene therapy.

Named to the Top 10 Honor Roll on US News & World Report’s 2024-25 list of “Best Children’s Hospitals,” Nationwide Children’s Hospital is one of America’s largest not-for-profit free-standing paediatric health care systems providing unique expertise in paediatric population health, behavioural health, genomics and health equity as the next frontiers in paediatric medicine, leading to best outcomes for the health of the whole child. 

 

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