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Mesenchymal Stem Cell (MSC) Manufacturing Platform

Our advanced industrial-scale cell therapy manufacturing capabilities support the full life cycle of production services, covering preclinical, Phase I/II/III clinical trials, and commercial-scale production.

Clinical Phase Production

Applicable to preclinical and early clinical stages (Phases I/II), with proof of concept, process optimization, and validation

Commercially Viable Production

Designed for the production of cell therapy products during Phase III clinical trials and commercialization, featuring fully automated, closed-system production with minimal manual intervention and reduced inter-batch variation.

Providing Full Life Cycle Services for Mesenchymal Cell Therapeutics Development

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

    ·Process Research

    ·Process Optimization and Validation

    ·Formulation and Process Development, Research, and Validation

  • Assay Development

    ·Development and Validation of Quality Analysis Methods

    ·Research and Establishment of Quality Attributes

  • 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 Drug Product Batches for Clinical Trial Registration

    ·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 Optimization and Validation

  • Continuous Improvement of Quality Attributes

    ·Comprehensive understanding of Quality attributes

    ·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

    ·Release Testing

  • Additional Services

    ·Clinical Trial Protocol Consulting

    ·Storage for Seed Cell Banks and Working Cell Banks

  • Large-scale Production and Quality Control System Validation

    ·Commercial Process Characterization, Process Validation and Continuous Process Validation

    ·Validation and Verification of Quality Assays

    ·Comparability Studies

  • Data Accumulation for Stability Studies

    ·Storage Stability

  • Large-Scale Production and Quality Control

    ·Production of Seed Cell Banks

    ·Production of Master Cell Banks

    ·Batch Release Testing

  • Additional Services

    ·eCTD Document Preparation Consulting

    ·Storage of Seed Cell Banks

    ·Storage of Master Cell Banks

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