Services
We offer a comprehensive range of services, from discovery to CMC readiness, covering the entire spectrum from concept to product release. Our mission is to help biotech and biopharma partners maintain high-quality and compliant cell and gene therapy (CGT) development processes.
Cell Therapy Services
- Cover a diverse range of cell therapy modalities, including CAR-T, TCR-T, CAR-NK/Macrophage, iPSC/HSC/MSC, and more.
- Provide full process development, from concept to CMC tech transfer readiness.
- Offer customized process scale-up and CMC readiness studies based on Quality by Design (QbD) principles.
- Deliver tailored analytical development to meet specific needs.
- Apply robust and cost-effective solutions.
Gene Therapy Services
- AAV, LVV, and retroviral vector design, with upstream and downstream manufacturing process development.
- Packing cell line development, clone selection and cell bank construction.
- Non-GMP studies(stability & forced degradation study).
- Comprehensive AAV vector assay development and testing services packages.
- Analytical qualification studies and on-site technology transfer.
Pre-clinical services
- Viral vector design and potency assay development.
- Pre-clinical efficacy proof-of-concept (POC) studies.
- In vitro and in vivo toxicology study design and execution.
- Design and development of transduction, potency, and purity assays.
- Comprehensive IND-enabling pre-clinical studies.
Translation services
- Cytokine Release Assays
- Persistence and Expansion Monitoring
- Minimal Residual Disease (MRD) Assessment
- Biomarker Analysis
- CAR-T Cell Phenotyping
- Immunogenicity Testing
- CAR-T Cell Functional Assays
- Blood and Tissue Biopsy Analysis