Made Scientific, a US-based cell therapy contract development and manufacturing organisation (CDMO), and Sentinel BioTherapeutics, a clinical-stage biotechnology company advancing encapsulated cell-based immunotherapies for solid tumours, on Tuesday announced a strategic manufacturing partnership to support the Phase I/II clinical development of Sentinel's SENT-001.

SENT-001 is an allogeneic, encapsulated cell therapy leveraging genetically engineered allogeneic ARPE-19 cells to enable localised delivery of native human IL-2 (interleukin-2) to the peritoneal or pleural cavities. The therapy was previously evaluated in a multicentre, open-label Phase I study for patients with high-grade serous adenocarcinoma of the ovary, fallopian tube, or primary peritoneum.

Sentinel BioTherapeutics is the first spinout company of RBL LLC, a Houston-based biotech accelerator focused on accelerating novel therapeutic delivery technologies to clinic.

As part of the collaboration, Made Scientific will establish a new GMP Master Cell Bank and support both process optimisation and clinical GMP drug product manufacturing of SENT-001 as an off-the-shelf product, enabling Sentinel's phase I/II study to include re-dosing and combinations with targeted immunotherapy drugs. The drug product manufacturing strategy introduces a closed, scalable production model designed to enhance operational efficiency, increase throughput, and reduce both manufacturing time and overall cost of goods. This approach is intended to facilitate clinical scalability and also to strengthen the therapy's long-term economic sustainability by automating manufacturing workflows, minimising resource requirements, and maximising drug product yield.