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Immune Cell Manufacturing Platform

Leveraging gene editing technologπ∏y, our platform is dedica≈‌ted to developing a wide✔™ range of immune cell₹♥÷σ therapy products, incl <✔uding NK cells, CAR-NK, CAR-T, TIL≈φ, and other mixed immune cell& s.

Manufacturing of Mixed Immune Cβ₹γ€ells

Tailored for Preclinical a‌↑nd Phase I/II Clinical±→ Trials, with continuous proc♥α≠÷ess exploration, optimization, ↓¶©±and validation.

Providing end-to-end serv  ices throughout the entire lifecycle of∞‌ immune therapy deve ™≠σlopment.

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

    ·Process Research

    ·Process Optimization and Validatio♥♦'n

    ·Formulation and Process Development, R"™>esearch, and Validation

  • Quality Standard Resear✔$ch

    ·Research and Establishment of Qual&↓₩ity Standards

    ·Development and Validation oα☆♠f Quality Analysis Methods

  • Stability Studies

    ·Accelerated Stability St∏‌♠udy

    ·Storage Stability Study

    ·Transport Stability Study

    ·In-Use Stability Study

  • Clinical Trial Registration Batch Produ₽φ∞ction and Testing

    ·Production of Seed Cell Baγδ∑™nk for Clinical Trial Registration B® →™atch

    ·Preparation of End-of-Product∞‌<∞ion Cell Bank for Cl€'inical Trial Registration Batch

    ·Batch Quality InspecΩ®tion

  • Additional Services

    ·Mechanism of Action Research

    ·Storage of Seed Cell Banφ&•k and Working Cell Ban≠<$↑k

    ·Preclinical Toxicology Study CΩ∞≥onsulting

    ·Preclinical Pharmacodyn↔✔ amics Study Consulting☆&¥

    ·CTD Document Prepara♦ tion Consulting

  • Continuous Process Optimization

    ·Process Optimization and Validation

    ·Formulation Process O$δ ptimization and Valiβ  ‌dation

  • Continuous Optimization of Quality ↔ππ♣Standards

    ·Optimization and Validation of Q≠↕uality Standards

    ·Optimization and Vali‌™dation of Quality Analα✘ysis Methods

  • Accumulation of Stability Data★→

    ·Storage Stability Stud↔δ>±ies

    ·In-Use Stability Studies

  • Small-scale Production and Vδ≠επerification

    ·Seed Cell Bank Production

    ·Working Cell Bank Production

    ·Batch Verification

  • Additional Services

    ·Clinical Trial Protoco™✘l Consulting

    ·Storage for Seed Cell Banks and Wo¥←♣λrking Cell Banks

  • Large-scale Production and Quality→¥≈ Control System Validation

    ·Production Process Scale-up Rλ☆©esearch, Validation and Process Ve× ♥rification

    ·Validation and Verification↓<$ of Quality Standards and A•βδnalytical Methods

  • Data Accumulation for Stability Studi&↑÷♦es

    ·Storage Stability

  • Large-Scale Production an↔α d Quality Control

    ·Production of Seed Cell‍β₹₩ Banks

    ·Production of Master Cell Banks

    ·Batch Quality Testing

  • Additional Services

    ·CTD Document Preparation Consulting

    ·Storage of Seed Cell B♦★®'anks

    ·Storage of Master Cell Banks↔γ