Cell Therapies, an Australian contract development and manufacturing organization (CDMO), has begun technology transfer with S2N.Bio to prepare an investigational Alzheimer’s disease treatment for Good Manufacturing Practice (GMP) production.

According to the announcement, the work will establish S2N’s manufacturing process, analytical methods, and documentation within Cell Therapies’ quality system ahead of clinical production planned for a first-in-human trial in 2027. The companies are collaborating through Australia’s SMART Cooperative Research Center, which supports development and translation of manufacturing technologies for regenerative medicines.

S2N is developing an autologous therapy using hair follicle-derived neuroprecursor cells collected from each patient. The cells are intended to differentiate into neurons and related cell types to replace neurons lost through neurodegeneration. The company says the cells are not genetically modified.

Before the transfer, S2N refined its manufacturing process at the University of Technology Sydney’s Biologics Innovation Facility, an ISO 9001:2015-certified pilot facility operating under GMP-like conditions. The development work included reproducibility studies, process documentation, and production runs, with Cell Therapies staff participating in later batches to prepare for the GMP manufacturing campaign.

S2N’s preclinical research includes a 2022 study published in Stem Cell Research & Therapy that evaluated autologous skin-derived neuroprecursor cells in five aged dogs with canine cognitive dysfunction. The company reported improvements in four animals, including complete reversal of the syndrome in two. However, these findings are preclinical and do not establish efficacy in humans.