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.
Applicable to preclinical and early clinical stages (Phases I/II), with ongoing process exploration, optimization, and validation
Designed for the production of cell therapy products during Phase III clinical trials and commercialization, featuring fully automated, closed-loop production with minimal manual intervention and reduced inter-batch variation.
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
