Cell therapy evaluation platform -Specialized drug efficacy research platform

1、Accelerating Cell Therapy Development | Efficacy Evaluation Platform Based on Clinically Predictive Models

• Industry Pain Point: cell therapy development faces technical challenges such as lengthy timelines, low clinical translation rates and poor simulation of the human microenvironment, leading to unreliable efficacy predictions.
• Value Proposition: Our customized, high-fidelity preclinical evaluation platform enables a 50% reduction in R&D cycle and significantly mitigates the risk of clinical failure.

2、Service Overview

Cell therapy is an emerging treatment for oncology, autoimmune diseases, and other areas, yet its clinical translation faces significant challenges: traditional animal models fail to accurately simulate the human immune microenvironment, leading to substantial deviations in efficacy prediction. Jennio Bio focuses on bridging the gap between preclinical and clinical stages. Utilizing PDX models, humanized immune systems, and functional assay platforms, we precisely evaluate the in vitro and in vivo activity of therapies such as CAR-T, TIL-T, and stem cells. We provide comprehensive support to pharmaceutical companies—from candidate drug screening to IND submission—to reduce R&D risks.

3、Our Services

• In Vitro Functional Evaluation
  • Stem Cell Characterization: Stem cell differentiation potential, product sterility testing, etc.
  • Immuno-Effector Assessment: T-cell specific response by ELISPOT, immunocyte subset analysis (CD3+/CD8+/Treg, etc.) by flow cytometry.
  • Soft Agar Clonogenic Assay: Safety evaluation for cell therapy products.
• In Vivo Efficacy Assessment

Evaluation of Tumor Immunotherapy:

• CDX/PDX Models: Assess the tumor inhibition rate and changes in tumor bioluminescent signals of CAR-T and TIL therapies in models such as the orthotopic Hela-luc cervical cancer model and liver cancer PDX models.
• Immune Microenvironment Analysis: Analyze Tumor-Infiltrating Lymphocytes (TILs) via flow cytometry; quantify serum inflammatory cytokines (e.g., IL-6, TNF-α) via ELISA.

• Evaluation of Stem Cell Therapies:
  • Neural Repair Model: Evaluate motor function recovery (motor scoring, histopathology) in a sciatic nerve injury model treated with MSCs combined with electroacupuncture.
  • Bone and Joint Repair: Detect cartilage regeneration (Safranin O staining) and assess inflammation suppression (via IL-1β/IL-6 detection) in an osteoarthritis model induced by anterior cruciate ligament transection (ACLT).
• In-Depth Mechanistic Studies

4、Technology Platforms and Advantages

• Core Platforms
  • Humanized Immune System Mice: Supports in vivo functional evaluation of immunotherapies, such as CAR-T.
  • Multi-omics Analysis Platform: Integrates transcriptomic (RNA-seq) and proteomic (mass spectrometry) data to elucidate therapeutic mechanisms.
• Differentiated Advantages
  • Highly Predictive Models: PDX models demonstrate 90% efficacy-clinical correlation, significantly outperforming traditional CDX models.
  • One-stop Solution: Covers the entire workflow from model establishment and efficacy evaluation to biomarker discovery.
  • Rapid Response: Project initiation within 48 hours, with support for expedited custom protocols.

5、Service Process(GLP-aligned standards）

• Requirement Communication: Respond within 1 working day and customize the experimental protocol (including dosage/time point optimization).
• Experiment Execution
  • Real-time data sharing (VR Progress Tracking System).
  • Strict quality control: double-blind sample testing, instrument calibration records.
• Data Delivery
  • Raw data (flow cytometry FCS files, original imaging images).
  • Statistical analysis report (TGI calculation, survival curves, P-value analysis).

6、Quality Control and Compliance

• Implementation Standards: Adhere to GLP-aligned specifications and meet the technical requirements of FDA/EMA/NMPA.
• Facility Certification: SPF-grade animal facility, BSL-2 laboratory.
• Data Traceability: Electronic laboratory record system, supporting third-party audits.

7、Case Studies

• Case 1: Efficacy Evaluation of CAR-T Therapy for Leukemia
  • Model: Nalm6-Luc NSG mouse leukemia model.
  • Results: Tumor fluorescence signal reduced by >70% in the treatment group (vs. control group), with 40% extension of survival period.
  • Data Support: Dynamic curves of in vivo imaging signals; flow cytometry detection of CD19+ cell clearance rate
• Case 2: Stem Cell Therapy for Osteoarthritis
  • Model: Rat ACLT osteoarthritis model.
  • Results: After 4 weeks of MSCs treatment, the articular cartilage injury score decreased by 50%, and the osteophyte formation inhibition rate exceeded 60%.
  • Data Support: Micro-CT 3D reconstruction; Safranin O-stained sections.

8、Collaboration Advantages

• Flexible Customization: Compatible with diverse therapies (CAR-T, TCR-T, stem cell therapies) and disease areas (oncology, autoimmune diseases).
• Efficient Delivery: Average turnaround time is 30% faster than the industry average, with support for rush projects.
• Cost Optimization: Share platform resources (e.g., PDX library, cell bank) to reduce the cost of individual projects.

9、FAQ

• Q: Do you support GLP reports that meet FDA filing requirements?

A: We provide GLP-aligned standard data reports that satisfy the preclinical filing data requirements.

• Q: Can you evaluate the long-term safety of cell therapies (e.g., tumorigenicity)?

A: We support long-term toxicity follow-up for over 6 months, including hematology, histopathology, and biodistribution testing.

10、Laboratory Highlights

• SPF Animal Center: 5,000-cage capacity, with independent operation rooms equipped with in vivo imaging systems and ventilators.
• Flow Cytometry Platform: laser analyzer supporting 12-color immunophenotyping analysis.
• Molecular Biology Platform: CRISPR editing, dual-luciferase reporter assay.

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11、Contact Us

• Consultation: One-on-one communication with technical experts (24-hour response).
• Resource Access:
  • Download the White Paper on Cell Therapy Evaluation Technology (including 10+ cases).
  • Apply for free customized solutions: Provision of preliminary experimental design and budget.
• Contact:
• Tel: +86 18802035152
• Email: 3691125803@qq.com