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Immune Cell Manufacturing Platform

Leveraging gene editing technology, our platform is dedicated to developing a wide range of immune cell therapy products, including NK cells, CAR-NK, CAR-T, TIL, and other mixed immune cells.

Manufacturing of Mixed Immune Cells

Tailored for Preclinical and Phase I/II Clinical Trials, with continuous process exploration, optimization, and validation.

Providing end-to-end services throughout the entire lifecycle of immune therapy development.

  • ·Pre-IND
  • ·Phase Ⅰ/Ⅱ
  • ·Phase Ⅲ/NDA
  • Process Development

    ·Process Research

    ·Process Optimization and Validation

    ·Formulation and Process Development, Research, and Validation

  • Quality Standard Research

    ·Research and Establishment of Quality Standards

    ·Development and Validation of Quality Analysis Methods

  • Stability Studies

    ·Accelerated Stability Study

    ·Storage Stability Study

    ·Transport Stability Study

    ·In-Use Stability Study

  • Clinical Trial Registration Batch Production and Testing

    ·Production of Seed Cell Bank for Clinical Trial Registration Batch

    ·Preparation of End-of-Production Cell Bank for Clinical Trial Registration Batch

    ·Batch Quality Inspection

  • Additional Services

    ·Mechanism of Action Research

    ·Storage of Seed Cell Bank and Working Cell Bank

    ·Preclinical Toxicology Study Consulting

    ·Preclinical Pharmacodynamics Study Consulting

    ·CTD Document Preparation Consulting

  • Continuous Process Optimization

    ·Process Optimization and Validation

    ·Formulation Process Optimization and Validation

  • Continuous Optimization of Quality Standards

    ·Optimization and Validation of Quality Standards

    ·Optimization and Validation of Quality Analysis Methods

  • Accumulation of Stability Data

    ·Storage Stability Studies

    ·In-Use Stability Studies

  • Small-scale Production and Verification

    ·Seed Cell Bank Production

    ·Working Cell Bank Production

    ·Batch Verification

  • Additional Services

    ·Clinical Trial Protocol Consulting

    ·Storage for Seed Cell Banks and Working Cell Banks

  • Large-scale Production and Quality Control System Validation

    ·Production Process Scale-up Research, Validation and Process Verification

    ·Validation and Verification of Quality Standards and Analytical Methods

  • Data Accumulation for Stability Studies

    ·Storage Stability

  • Large-Scale Production and Quality Control

    ·Production of Seed Cell Banks

    ·Production of Master Cell Banks

    ·Batch Quality Testing

  • Additional Services

    ·CTD Document Preparation Consulting

    ·Storage of Seed Cell Banks

    ·Storage of Master Cell Banks

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