Theragent has announced 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 Theragent COO, Jeff Masten. “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, Chief Executive Officer of Accelerated Biosciences, stated, “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.
About Theragent
Theragent is an advanced therapeutics Contract Development Manufacturing Organization in Arcadia, CA, focused on novel cell and gene therapies for the treatment of cancer and rare diseases. The company’s innovative cGMP facility offers comprehensive end-to-end manufacturing and in-house testing capabilities for clinical and commercial purposes. With an emphasis on quality, safety, and manufacturing, Theragent strives to provide value-added solutions for clients with challenging pre-clinical and clinical trial projects.
Theragent. Patients are waiting. For more information, visit www.theragent.com.
About Accelerated Biosciences
Founded in 2013, Accelerated Biosciences is a private company focused on regenerative medicine and built around the hTSC discoveries of obstetrics and gynecology physician and researcher, Professor Jau-Nan Lee, MB, MD, PhD. Accelerated Biosciences holds a large and robust patent portfolio and an encumbrance-free intellectual property (IP) estate. Accelerated Biosciences’ mission is to leverage its renewable, immune-privileged human cell source to fuel breakthrough cell therapies that effectively target the most challenging diseases of the human body. For more information about Accelerated Biosciences, visit acceleratedbio.com or email yuta.lee@acceleratedbio.com.
Contact
Brian Misiner, Head of Business Development at Theragent
bmisiner@theragent.com
Yuta Lee, Chief Executive Officer at Accelerated Bio
yuta.lee@acceleratedbio.com