Cambridge GenetiX 

Clinical Pipeline 

A single, secure platform to design, run, and release clinical CART batches with full electronic traceability and regulatorygrade documentation.

GXM is a purposebuilt software platform for cell and gene therapy teams who need to run compliant CART manufacturing without drowning in paper. The system guides operators stepbystep through cGMP workflows, captures data directly from instruments, and automatically generates electronic batch records with full audit trails and electronic signatures, supporting 21 CFR Part 11 and EU Annex 11 expectations.

Cell and Gene Therapy  

At Cambridge GenetiX, we engineer therapeutic cells designed to transform and potentially cure human disease

Our LogicGate platform enables precise cellular programming for superior therapeutic delivery and performance

Supported by a modular manufacturing system, we provide scalable and economical production of next generation cell and gene therapy products. 

GX-01 (Ariflex) 
GX-02 (Anti BCMA CAR-T). 
GX-03  

Biologics 

At Cambridge GenetiX, we engineer therapeutic cells designed to transform and potentially cure human disease.

At Cambridge GenetiX, we engineer therapeutic cells designed to transform and potentially cure human disease.

Software for Clinical Cell and Gene Therapy Production: 

At Cambridge GenetiX, we engineer therapeutic cells designed to transform and potentially cure human disease.

Clinical Grade Reagents (GMP)  

At Cambridge GenetiX, we’ve developed a modular reagent kit designed to simplify and standardize the production of autologous CART cells. Each component has been carefully selected to support highquality cell engineering while maintaining costefficiency and scalability. The reagents included in this kit are sourced from leading global suppliers recognized for excellence in cell and gene therapy (CGT) manufacturing. The same grade and formulation are used in the production of our proprietary CART therapy, Ariflex™, ensuring clinical relevance and reliability. Our CART PerPatient Kit provides a readytouse, integrated solution for academic and industry researchers developing patientspecific CART products. It includes all essential reagents needed for cell isolation, activation, transduction, and expansion, with clear documentation and optimized protocols to streamline the process from start to finish.
The CAR Detection Reagent from Cambridge GenetiX enables rapid, reliable assessment of CAR expression on engineered T cells. Designed for use in flow cytometry and other immunoassay formats, this reagent provides sensitive detection of cells expressing chimeric antigen receptors—making it an essential tool for process verification, product release, and research optimization. Each lot is manufactured under rigorous quality control to ensure batch‑to‑batch consistency and high specificity across a range of CAR constructs. The reagent is compatible with most CAR extracellular domain designs, including scFv‑based and ligand‑binding formats. Used routinely in the production of our proprietary CAR‑T therapy, Ariflex™, this detection reagent delivers the same clinical‑grade performance standards trusted in our internal manufacturing workflows. It empowers developers to confidently confirm transduction efficiency and surface CAR expression in both research and GMP development settings.

At Cambridge GenetiX, we engineer therapeutic cells designed to transform and potentially cure human disease.

The Cambridge GenetiX CART Cell Extensive Characterization Panel is a multicolor flow cytometry panel designed to profile CART phenotype, differentiation, and activation status in a single assay. It supports inprocess monitoring during manufacturing, lotrelease characterization, and longitudinal patientsample analysis, providing a highcontent view of product quality.
A typical panel configuration can include:
⦁ Lineage and panT markers: CD3, CD4, CD8, CD45 (Tcell identification and major subsets).
⦁ Memory and differentiation markers: CD45RA, CD45RO, CCR7, CD62L, CD27, CD28, CD95(naïve, central memory, effector memory, TEMRA, and stemlike memory definition).
⦁ Activation and costimulation markers: CD69, CD25, 41BB (CD137), OX40 (CD134), HLADR(early and sustained activation, costimulatory engagement).
⦁ Proliferation/fitness markers: Ki67 (cycling status), optional inclusion of CD127 (IL7Rα) for survival potential.
⦁ CAR tracking and Bcell exclusion: antiCAR detection reagent (compatible with your CAR construct) and CD19 or other target antigen where relevant.
Used together, these markers allow you to resolve CART products into functionally meaningful subsets (e.g., CD4 vs CD8, naïve vs memory, activated vs resting) and to track how the phenotype evolves across the manufacturing process or after infusion. This panel is intended for research use and can be adapted to your preferred fluorochrome backbone and cytometer configuration

At Cambridge GenetiX, we engineer therapeutic cells designed to transform and potentially cure human disease.

CAR-T Potency Test kits

CGx Cytokine Potency IFN‑γ ELISA Kit – Sensitive IFN‑γ quantification kit for measuring CAR‑T functional activation following antigen‑specific stimulation. CGx Cytokine Potency Multi‑Analyte Panel – Multiplex cytokine assay for simultaneous measurement of IFN‑γ, IL‑2, TNF‑α and other key effector molecules.

CGx TruTarget CAR Antigen Bead Set – Antigen‑coated particles that provide stable, lot‑to‑lot‑consistent surrogates for CAR‑T potency and assay control.

Qualified reference cells for benchmarking assay performance and ensuring long‑term potency assay comparability.
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