Our advanced industrial-scale cell theδ<rapy manufacturing capa€bilities support the full l←ife cycle of product £ion services, covering preclinic↑$al, Phase I/II/III clinical trials, and×↑↓ commercial-scale productio"•✔n.
Applicable to preclin€∏ical and early clinical stages (♦₽↕Phases I/II), with proof of concept, p≠ ←±rocess optimization, and validation
Designed for the production of ce ∞ll therapy products duri≈€♠∏ng Phase III clinical β$trials and commercializatio✔♣γn, featuring fully automateπ∏d, closed-system production < with minimal manual intervention and r↕±≤educed inter-batch variation.
Process Development·Process Research
·Process Optimization and ₩→πValidation
·Formulation and Process Developmeδ§nt, Research, and Validation
Assay Development·Development and Validation of Qualityβ& Analysis Methods
·Research and Establishment of Quality ≈∞™γAttributes
Stability Studies·Accelerated Stability Study
·Storage Stability Study
·Transport Stability Study
·In-Use Stability Stu♠∞ dy
Clinical Trial Registration Batch Prod>✔βuction and Testing·Production of Seed Cell Bank for C®Ωlinical Trial Registrat₹∏ion Batch
·Preparation of Drug Product Batc≈©♦hes for Clinical Tri₩✘al Registration
·Batch Quality Inspection
Additional Services·Mechanism of Action Rese♦∏arch
·Storage of Seed Cell Bank a σ€↑nd Working Cell Bank
·Preclinical Toxicology Study Coγ§∏ nsulting
·Preclinical Pharmacodynam₹←≠φics Study Consulting
·CTD Document Preparation Consulting
Continuous Process Optimization·Process Optimization and Vaσ₹♦±lidation
·Formulation Optimization and Vali↔dation
Continuous Improvement of Qua$εβlity Attributes·Comprehensive understanding o&© f Quality attributes
·Optimization and Validation of ☆Quality Analysis Methods
Accumulation of Stability ↓δ∏Data·Storage Stability Studie÷& s
·In-Use Stability Studies
Small-scale Production and Ver •ification·Seed Cell Bank Production
·Working Cell Bank Production
·Release Testing
Additional Services·Clinical Trial Protocol Consulting>¥§
·Storage for Seed Cell Banks and Workin≥βg Cell Banks
Large-scale Producti∏ >♦on and Quality Control System Validaε≤tion·Commercial Process C→∞↓ haracterization, Process Validation an♥™d Continuous Process☆₽ Validation
·Validation and Verification of Quality≤& Assays
·Comparability Studies
Data Accumulation for Stα₩ability Studies·Storage Stability
Large-Scale Production and Quality Cβ♦←ontrol·Production of Seed Cell B∏×>✔anks
·Production of Master Cell€γ$ Banks
·Batch Release Testin✔∏£g
Additional Services·eCTD Document Preparat±$¥≤ion Consulting
·Storage of Seed Cell ₹✔∞Banks
·Storage of Master Cell∏φ Banks
