Cell Therapy Analytical Development and Quality Control Services

Analytical testing ensures the safety, potency, purity, and identity of cell therapy products, meeting regulatory standards and guaranteeing therapeutic efficacy. It also identifies impurities or contaminants that could compromise product quality or patient safety.

We specialize in testing CAR-T, CAR-NK, TIL, iPSC, and MSC-based therapies, providing tailored analytical development and QC testing to meet the unique requirements of each platform.

Key tests include identity verification, viability assays, potency testing, microbial testing, endotoxin detection, and mycoplasma screening. Advanced methods like flow cytometry and molecular assays are also utilized.

Yes, our experienced cell therapy analytical development scientists can provide custom assay development and validation services tailored to your cell therapy product’s unique needs, ensuring compliance with regulatory guidelines.

Yes, we conduct storage stability studies under various conditions to assess cell viability, potency, and quality over time, helping establish product shelf life and storage conditions. We can also help with cell therapy rapid QC release for fresh cell products.

Potency testing is conducted through functional assays such as cytotoxicity assays, cytokine release assays, and target cell-killing assays, depending on the cell therapy product’s mechanism of action.

Yes, we offer flow cytometry-based CAR expression assays to confirm the functionality and surface expression of CAR constructs in modified cells.

Turnaround times depend on the specific assays and project complexity. We work closely with clients to establish timelines that align with their development and manufacturing schedules.

We leverage advanced technologies such as flow cytometry, qPCR, ELISA, next-generation sequencing (NGS), and high-performance liquid chromatography (HPLC).

Detection of CAR-positive cells can be achieved using Protein L or specific antibodies targeting the SCFV or VHH domain of the CAR. Universal antibodies recognizing constant regions, such as G4S or Whitlow linker sequences, are also commonly used.

Maintaining sterility, controlling endotoxin levels, and detecting mycoplasma contamination are the most challenging aspects of TIL testing. These factors ensure the reliability, safety, and quality of TIL products.

At uBriGene, we use multiple approaches to assess the pluripotency phenotype of iPSCs comprehensively. Flow cytometry is employed to quantify pluripotency surface markers, such as SSEA-3, SSEA-4, TRA-1-60, and TRA-1-81. Functional assays, including embryoid body formation, are conducted to confirm differentiation into cell types from all three germ layers.

Additionally, protein expression is evaluated via immunocytochemistry by staining for key pluripotency markers like OCT4, NANOG, SSEA-4, and TRA-1-60. This multifaceted evaluation ensures a thorough assessment of iPSC pluripotency, supporting their readiness for various research and regenerative medicine applications.

Various methods are available for conducting CAR-T in vitro cytotoxicity assays, including lactate dehydrogenase (LDH) release assays, flow cytometry (FACS), clonogenic inhibition assays, cell viability assays (MTT/CCK-8), real-time cell analysis (RTCA), and ELISPOT detection. The choice of technique typically depends on the specific characteristics of the target cells susceptible to CAR-T-mediated lysis.

At uBriGene, the FACS method is predominantly used, involving the establishment of stable target cell lines identifiable through flow cytometry, enabling precise cytotoxicity assessments of CAR-T cells. uBriGene offers customized assay adaptations to meet clients’ specific needs, ensuring accurate cytotoxicity evaluations and valuable insights for CAR-T therapy development.