Theragent
Theragent is a cGMP-compliant cell and gene therapy CDMO operating from Arcadia, California, providing end-to-end contract development, manufacturing, and regulatory services across seven cell therapy modalities for biotech and biopharma sponsors developing cancer and regenerative medicine products.
- Company typePrivate
- Founded2019
- HeadquartersArcadia, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Theragent does
Theragent is a full-service, cGMP-compliant contract development and manufacturing organization (CDMO) for cell and gene therapies, headquartered in Arcadia, California. Founded in 2019, the company operates two facilities — the Arcadia cGMP facility (11,250 sq. ft. of manufacturing space with four ISO 7/8 modular cleanroom suites, opened 2022) and the Covina Discovery Lab (6,000 sq. ft. for process and analytical development) — providing integrated services from preclinical research through commercial manufacturing for biotech and biopharma sponsors. Its manufacturing portfolio spans seven cell therapy modalities: CAR-T cells, regulatory T cells (Treg), induced pluripotent stem cells (iPSC), mesenchymal stem cells (MSC), hematopoietic stem cells (HSC), natural killer (NK) cells, and multicell combinations, supported by proprietary process assets including feeder-free NK cell expansion protocols, a suspension-adapted 293T lentiviral production line, and a CD137 tonic signaling assay.
Theragent's technical platform is differentiated by its Pharma 4.0 digital infrastructure, built on an exclusive multi-year partnership with Insight68 for AI-driven manufacturing software, delivering paperless electronic batch records, predictive production planning, and real-time client visibility through a secure web portal. Supporting services include process development, analytical development, quality assurance and control, regulatory affairs (including IND filing support), and digital supply chain management with barcoded sample tracking and cryopreservation monitoring. The company pursues a B2B enterprise sales motion targeting biotech and biopharma sponsors developing cancer immunotherapies and regenerative medicine products, generating revenue through project-based, multi-year contracts with quote-based pricing tied to manufacturing runs, analytical testing scope, and regulatory support requirements.
The company serves customers primarily through direct enterprise sales and industry conference engagement, with named clients including CellVax Therapeutics (manufacturing for the FDA-cleared IND-stage FK-PC101 prostate cancer immunotherapy) and Accelerated Biosciences (cGMP master cell bank production for human Trophoblast Stem Cells). Strategic technology partnerships include Pluristyx for end-to-end iPSC-derived therapy development and Insight68 for AI-driven manufacturing digitalization. Leadership comprises founder-CEO Yun Yen, MD/PhD (40+ years in oncology), CFO Joseph Huang, SVP Operations Weifeng Zhang (ex-Tanvex, GenScript, BMS), and VP Business Development Brian Newsom (ex-KBI Biopharma, Thermo Fisher), with headcount in the 11-50 range. No external funding rounds have been disclosed, indicating founder-financed growth.
Theragent firmographics
Firmographics- Name
- Theragent
- Legal name
- Theragent Inc.
- Website
- https://theragent.com
- Company type
- Private
- Founded year
- 2019
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Theragent is a cGMP-compliant cell and gene therapy CDMO operating from Arcadia, California, providing end-to-end contract development, manufacturing, and regulatory services across seven cell therapy modalities for biotech and biopharma sponsors developing cancer and regenerative medicine products.
- Ownership category
- akta.pro rank
Theragent industry classification
Industry- Product category
- Cell Therapy Contract Manufacturing (CDMO)
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Services-Commercial Physical & Biological Research (8731), Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Cell Therapy CDMO (HLAGABAD)
- akta.pro secondary industries
- Gene Therapy Vector Manufacturing & CDMO Services (HLAAACAJ), Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK)
Keywords
Where Theragent is headquartered
LocationHeadquarters
- HQ city
- Arcadia
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Theragent business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Infrastructure, Technology or R&D, Operations, Supply Chain
Revenue model
- CDMO Manufacturing Services: Contract Development and Manufacturing Organization providing end-to-end manufacturing and testing services for cell and gene therapy sponsors. Revenue is generated through project-based contracts for process development, analytical development, clinical manufacturing, and regulatory affairs support services
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom project-based pricing |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels5 records
Theragent product offering
Product offeringCore offering
Theragent is a full-service, cGMP compliant cell and gene therapy Contract Development and Manufacturing Organization (CDMO) that provides end-to-end manufacturing, analytical testing, process development, and regulatory affairs services for biotech and biopharma sponsors. The company manufactures multiple cell therapy modalities (CAR-T, Treg, iPSC, MSC, HSC, NK cells, and multicell therapies) for cancer and rare disease applications at its 26,000 ft² facilities in Southern California.
Product overview
Theragent is a full-service, cGMP compliant cell and gene therapy CDMO based in Southern California offering integrated contract development and manufacturing services. The company operates two facilities (Covina Discovery Lab for R&D and Arcadia cGMP Facility for clinical/commercial production) and manufactures seven distinct cell therapy modalities: CAR-T cells, Treg cells, iPSCs, MSCs, HSCs, NK cells, and multicell therapies. These manufacturing capabilities are supported by six core services spanning R&D, process development, analytical development, clinical manufacturing, quality assurance/control, regulatory affairs, and supply chain management. The company's Pharma 4.0-enabled infrastructure provides digital batch record compliance and real-time manufacturing transparency for clients developing cancer and rare disease treatments.
Differentiator
Problem solved
Functional benefit
Products and services
- CAR-T Cell Manufacturing Genetically modified T-cell manufacturing services for chimeric antigen receptor (CAR) therapies, including patient collection, cell processing, and testing standards for clinical and commercial production.
- Treg Cell Manufacturing Regulatory T cell (Treg) isolation, expansion, and banking services for immunosuppressive cellular therapies targeting autoimmune, inflammatory, and transplant-related diseases.
- iPSC Services Induced pluripotent stem cell reprogramming, validation, banking, and differentiation services for regenerative medicine and allogeneic cell therapy development.
- MSC Manufacturing Mesenchymal stem cell isolation, characterization, expansion, and differentiation services for tissue regeneration and immune modulation applications.
- HSC Manufacturing Hematopoietic stem cell isolation, expansion, gene modification, and cryopreservation services for blood disease and immune disorder treatments.
- NK Cell Manufacturing Natural killer cell activation and expansion services, including feeder-free platforms for solid tumor immunotherapy applications.
- Multicell Therapies Co-culture manufacturing services for multiple cell type combinations, including NK/T-cell multicell conjugates for combined innate and adaptive immune response therapies.
- Research & Development Preclinical research services including primary T cell culture, cell line generation, flow cytometry, and immunoassays for CAR-T and NK-based immunotherapy development.
- Process Development Critical Quality Attribute and Critical Process Parameter establishment, scalability design, reagent optimization, and cell isolation/transduction services.
- Analytical Development Method development for identity, purity, potency, and stability testing including flow cytometry, ELISA, cell-based assays, and qPCR/ddPCR.
- Clinical Manufacturing cGMP clinical batch production for autologous and allogeneic cell therapies with in-house analytical testing and batch release services.
- Quality Assurance & Control Endotoxin, mycoplasma, bioburden, sterility testing, environmental monitoring, and method validation services with electronic QMS integration.
- Regulatory Affairs Strategic regulatory guidance, GAP assessments, IND filing support, and CMC life cycle management for cell and gene therapy programs.
- Supply Chain Management Digital ERP-enabled supply chain with real-time patient sample tracking, demand forecasting, and cold chain management.
Quantifiable outcome
- Dramatically shorter batch turnaround times through in-house testing vs external laboratories
- +2 more outcomes
Companies that use Theragent
Customer profileNamed customers2 records
Segments3 records
Ideal customer profiles1 record
Theragent technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability1 record
Feature6 records
Theragent partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core.
- PluristyxcorePartnership to provide seamless end-to-end pathway for iPSC-derived therapy development from iPSC derivation to commercial production. Pluristyx provides iPSC platform including licenses for iPSC derivation, consent for use, FailSafe functional suicide switch, and iACT Stealth Cells immune evasion technology. Programs are transferred to Theragent for GMP processing and clinical-to-commercial scale production.
- Insight68coreMulti-year exclusive contract for AI-driven software to digitalize and streamline cell therapy manufacturing. Insight68 platform provides automated ordering, production planning, scheduling, and execution with real-time client access to batch runs. Includes electronic batch records, cGMP electronic equipment use logs, facility cleaning e-logbooks, and electronic lab notebooks.
- Accelerated BiosciencescoreAgreement for Theragent to produce cGMP-grade master cell bank (MCB) for Accelerated Biosciences' novel human Trophoblast Stem Cells (hTSCs). hTSCs are pluripotent and immune-privileged stem cells derived from an ethical source that can be differentiated into various cell therapies.
- CellVax TherapeuticscoreManufacturing partnership for FK-PC101, CellVax's novel personalized cancer immunotherapy for prostate cancer. Theragent provides end-to-end manufacturing, release, and disposition of all clinical material from its Arcadia cGMP facility for Phase 2 clinical trials.
Scale indicators7 records
Recent moves7 records
Expansion highlights5 records
Theragent competitors and assessment
Company assessmentEmerging players
- IsoPlexis: Single-cell analytics platform provider serving cell therapy developers with characterization tools. Adjacent to Theragent's analytical development services and competes for analytical method development budgets at CGT sponsors.
- Cellares: Emerging cell therapy manufacturing technology company developing automated, closed-system Cell Shuttle platforms for CGT CDMO services. Competes with Theragent for cell therapy manufacturing clients by offering automated, scalable alternatives to traditional cleanroom-based CDMOs.
Broad incumbents
- Lonza: Global CDMO leader with a significant cell and gene therapy manufacturing footprint across multiple sites. Directly comparable to Theragent as a competitor for clinical and commercial CGT CDMO contracts, but operates at vastly larger scale and scope (biologics, small molecules, cell therapy).
- Catalent: Major CDMO with cell therapy manufacturing capabilities (recently acquired by Novo Holdings). Competes for the same CGT sponsor clients as Theragent and offers broader service lines including fill-finish and commercial-scale biologics manufacturing.
- GenScript Probio: CDMO arm of GenScript providing cell therapy, viral vector, and plasmid manufacturing services. Direct competitor in the CGT CDMO market; Theragent's SVP of Operations Weifeng Zhang previously served as VP and GMP Site Head at GenScript Probio USA.
- Charles River Laboratories: Large CRO/CDMO with cell and gene therapy manufacturing services via its Cell & Gene Therapy CDMO business. A direct competitor for CGT clinical manufacturing contracts, with broader discovery, safety, and CDMO capabilities than Theragent.
Direct peers
- AGC Biologics: Global CDMO with cell and gene therapy manufacturing capabilities and multiple GMP sites. Competes directly with Theragent for CGT clinical and commercial manufacturing contracts; larger scale but similar service-line breadth.
- Resilience: Biomanufacturing CDMO with significant cell and gene therapy capacity across multiple U.S. sites. Competes with Theragent for clinical and commercial CGT contracts; well-capitalized and pursuing a tech-enabled manufacturing strategy similar in spirit to Theragent's Pharma 4.0 approach.
- KBI Biopharma: Mid-sized CDMO offering cell therapy and biologics manufacturing services. Highly comparable to Theragent in scope and client profile; notably, Theragent's VP of Business Development Brian Newsom joined from KBI Biopharma, signaling close market positioning.
Others
- Pluristyx: iPSC platform provider partnered with Theragent (May 2024) to offer end-to-end iPSC-derived therapy development. While Pluristyx is a strategic partner rather than a competitor, it is ecosystem-relevant because its licensing model drives a pipeline of iPSC clients directly into Theragent's GMP operations.
Market position
Strengths4 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
Theragent social profiles
Digital presenceTheragent compliance and trust
Trust signalCompliance1 record
Theragent financial estimates
Financial estimateRevenue estimate
Valuation estimate
Theragent leadership team
Management profileNumber of profiles
Profiles5 records
Theragent funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Theragent M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Theragent
What does Theragent do?
Theragent is a full-service, cGMP compliant cell and gene therapy Contract Development and Manufacturing Organization (CDMO) that provides end-to-end manufacturing, analytical testing, process development, and regulatory affairs services for biotech and biopharma sponsors. The company manufactures multiple cell therapy modalities (CAR-T, Treg, iPSC, MSC, HSC, NK cells, and multicell therapies) for cancer and rare disease applications at its 26,000 ft² facilities in Southern California.
Is Theragent a public or private company?
Theragent is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Theragent founded?
Theragent was founded in 2019. It employs 11 to 50 people.
Where is Theragent based?
Theragent is headquartered in Arcadia, United States, in the North America region.
How does Theragent make money?
One revenue line is on record: CDMO Manufacturing Services.
Who are Theragent's main competitors?
Emerging players on record are IsoPlexis and Cellares. Broad incumbents are Lonza, Catalent, GenScript Probio and Charles River Laboratories. Direct peers are AGC Biologics, Resilience and KBI Biopharma. Pluristyx is listed as an others.
Does Theragent have an API?
No public API is recorded for Theragent.
What industry is Theragent in?
Theragent's product category is Cell Therapy Contract Manufacturing (CDMO). Its primary akta.pro industry code is HLAGABAD, Cell Therapy CDMO, with a secondary code of HLAAACAJ, Gene Therapy Vector Manufacturing & CDMO Services. Its NAICS code is 325414 and its SIC code is 8731.