ARScience Biotherapeutics, a clinical-stage biotechnology company, has initiated the commercial technology transfer of its low-dose Interleukin-2 (LD IL-2) manufacturing process, marking a key step toward commercial-scale production.

The technology transfer will transition manufacturing processes, analytical methods, and technical expertise from the current clinical-stage facility to a commercial-scale, cGMP-ready manufacturing site. 

The initiative will establish a scalable manufacturing platform for LD IL-2, which is being developed in partnership with Coya Therapeutics for the treatment of amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases.

Dr. Gustavo Mahler, Chief Executive Officer, ARScience Biotherapeutics, said, "The initiation of this technology transfer represents a defining moment for ARScience.  

“This milestone is not only a validation of our platform — it is a commitment to the patients who stand to benefit from LD IL-2, and we are fully dedicated to delivering a commercial-ready process that meets the highest regulatory standards,” Dr. Mahler added. 

ARScience expects the technology transfer to be substantially completed and the commercial manufacturing process fully qualified by the fourth quarter of 2027.