Theragent is a biotechnology company that develops cell-based immunotherapies for cancer patients, focusing on robust and scalable manufacturing processes. By providing comprehensive services in research, development, and clinical manufacturing, Theragent addresses the need for effective treatment options in oncology and rare diseases.
Funding
Funding not disclosed
Founders
Product
Problem
Developing effective cell-based immunotherapies for cancer and rare diseases is hindered by the complexities of research, process development, analytical testing, and clinical manufacturing, often requiring specialized expertise and infrastructure that many companies lack. Ensuring product safety, reproducibility, and adherence to regulatory standards throughout the development and manufacturing lifecycle adds further challenges.
Solution
Theragent is a contract development and manufacturing organization (CDMO) that provides comprehensive services to support the development and manufacturing of cell and gene therapies, offering expertise from early-stage research and development through clinical manufacturing and commercialization. The company leverages experienced immunology and oncology R&D scientists, coupled with translational medicine and drug discovery knowledge, to augment clients' internal capabilities. Theragent designs processes with manufacturability in mind, starting with Critical Quality Attributes (CQAs) and establishing Critical Process Parameters (CPPs) while considering scalability and media optimization. The company develops custom analytical methods tailored to specific portfolio assets, ensuring efficient transfer of phase-appropriate methods to quality control, and offers strategic regulatory guidance to help clients navigate the regulatory landscape.
Target Audience
Theragent serves biotechnology and pharmaceutical companies, research institutions, and other organizations involved in the development and manufacturing of cell and gene therapies for oncology and rare diseases.
Features
- R&D services including primary screening, cell line generation, process establishment, characterization, and potency assays
- Process development services including process characterization, scalability assessment (2D or 3D cell culture), reagent optimization, and process optimization for cell isolation, modification, and expansion
- Analytical development services including analytical target profile definition, assay development (raw material, in-process, product characterization, and potency), clinical readiness, and lifecycle management
- Clinical manufacturing in ISO 7 validated manufacturing suites with biosafety cabinets and incubators
- Quality assurance and control services utilizing fully electronic systems for QMS, EMS, BMS, validation, and LIMS, aligned to phase-appropriate GMPs
- Regulatory affairs support, including guidance on global regulatory standards, regulatory pathway definition, and CMC lifecycle management
- Supply chain management utilizing a modern ERP system for demand planning, sample tracking, and cold chain management
- In-house analytical capabilities including viable cell count, endotoxin, mycoplasma, sterility/bioburden, microbial ID, flow cytometry, ELISA, cell-based assays, and rtPCR/ddPCR