Theragent Inc. is a comprehensive contract development and manufacturing organization (CDMO) specializing in cell and gene therapies, particularly focusing on CAR-T cell therapies. The company operates under cGMP compliance and offers a wide range of services, including research and development, process development, analytical development, clinical manufacturing, quality assurance, regulatory affairs, and supply chain management. Their expertise lies in transforming advanced therapies into successful clinical and commercial products, leveraging state-of-the-art technologies and integrated discovery platforms. Theragent's capabilities extend to both autologous and allogeneic CAR-T cell therapies, addressing the complexities of manufacturing and distribution while ensuring compliance with stringent regulatory standards.

In the realm of analytical development, Theragent emphasizes the importance of tailored analytical methods to ensure the characterization and quality of cell therapies. Their approach includes developing a comprehensive Analytical Target Profile (ATP) that guides the lifecycle of analytical development, from assay design to method qualification. The company boasts in-house capabilities for a variety of analytical tests, such as viable cell counts, sterility testing, and flow cytometry, which facilitate faster turnaround times and enhance the reliability of results. By integrating advanced technologies and a strategic plan for Chemistry, Manufacturing, and Controls (CMC), Theragent aims to uphold the consistency and safety of therapeutic products, ultimately contributing to improved patient outcomes.

United States

Theragent is a full-service cGMP Contract Development and Manufacturing Organization delivering innovative cell and gene therapy products to clients and patients around the world. Ourâ¯expert staff and state of the art facility serves as a âone stop shopâ? for all biopharma stakeholders seeking assistance in manufacturing and product development. Theragentâs cGMP facility features four manufacturing clean suites equipped with Digital DES technology, in house QC/QA, Microbiology, MSAT capabilities, and custom designed ERP system with paperless MBRs for real time reporting.

Theragent Inc.

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