- Made Scientific has entered a manufacturing partnership with Sentinel BioTherapeutics to support the Phase I/II clinical development of SENT-001.
- The CDMO will establish a new GMP Master Cell Bank and provide clinical GMP manufacturing at its Princeton, NJ, facility.
Made Scientific, a U.S.-based cell therapy CDMO, has announced a strategic partnership with Sentinel BioTherapeutics, a clinical-stage biotechnology company, to support the development of SENT-001, an encapsulated cell-based immunotherapy targeting solid tumours.
The agreement focuses on SENT-001, a genetically engineered, allogeneic ARPE-19 cell therapy designed to locally deliver native human IL-2. The therapy has previously been assessed in a Phase I clinical trial (NCT05538624) involving patients with high-grade serous adenocarcinoma. Sentinel is the first spinout of RBL LLC, a biotech accelerator based in Houston.
Under the partnership, Made Scientific will create a new GMP Master Cell Bank and oversee process optimisation and drug product manufacturing of SENT-001. The treatment will be produced as an off-the-shelf product to support a Phase I/II study, which includes plans for re-dosing and combination with targeted immunotherapies.
The manufacturing model will use a closed, scalable system intended to improve efficiency, reduce production time, and lower the cost of goods. According to the release, this approach will support both clinical scalability and long-term economic viability.
“This partnership builds on our shared track record of innovation and delivery,” said Syed T. Husain, Chairman & CEO of Made Scientific. “It also leverages MADE’s newly established Princeton, NJ site—purpose-built to support partners like Sentinel from early clinical development through late-stage and commercial manufacturing.”
