Theragent, a cell therapy contract development and manufacturing organization (CDMO) focused on advancing next-generation cancer and rare disease treatments, has formed an agreement with Accelerated Biosciences, a regenerative medicine innovator, to produce the cGMP-grade master cell bank (MCB) for Accelerated Biosciences’ novel human Trophoblast Stem Cells (hTSCs).

Accelerated Biosciences’ hTSCs are pluripotent and immune-privileged stem cells that are derived from an ethical source and can be differentiated into a number of cell therapies. With novel legal, ethical, and intellectual property advantages, including a high expansion capacity and a unique genetic identity not associated with any person or embryo, hTSCs are an ideal starting material for manufacturing next-generation advanced therapies. Theragent will produce the master cell bank that will be available for purchase or license through Accelerated Biosciences.

“We look forward to working with Accelerated Biosciences and producing this critical master cell bank,” said Jeff Masten, chief operating officer, Theragent. “Bringing together our cell-based know-how and cGMP quality system to deliver a fully characterized MCB will allow cell therapy developers to harness this novel pluripotent platform and advance new therapies for patients in need.”

Theragent’s modernized CDMO facility is fully GMP compliant and equipped with state-of-the-art Pharma 4.0 technology, making it the ideal setting for stem cell bank production.

Yuta Lee, CEO of Accelerated Biosciences, said, “We recognized early on that there is an unmet need for a clinical-grade, pluripotent stem cell platform derived from an ethical source with complete regulatory compliance documentation. To meet this need, we aim to make our patented hTSC source readily available to industry partners in order to accelerate cures to market. Key to this is the production of the cGMP-grade master cell bank, and Theragent is the ideal partner for us in this regard.”

The hTSC GMP master cell bank will come with a regulatory support package and be available for purchase or licensing to cell and gene therapy and biomanufacturing partners in Q1 of 2023.