Development and Manufacturing at Pre-IND stage (CAR-T Therapy)
At OBiO, we offer development and manufacturing services for autologous and allogeneic cell therapy products including CAR-T therapy, universal T-cell therapy, natural killer (NK) cell therapy, and hematopoietic stem cell therapy.
1
Isolation and Activation
Cell analysis, screening, activation; Cell culture process development, analytical method development
Proliferation of modified cells to the clinical required quantities
4
Quality Control and Release
Quality control system in compliance with regulatory requirements
5
Deliverables
Package including standard-compliant CAR-T cell products, Certificate of Analysis, batch production record, batch inspection record, and relevant Chemistry Manufacturing and Control (CMC) dossier
Development and Manufacturing at Post-IND stage
6
1
Process Transfer and Scale-up
Project-related process transfer; or further process scaling-up
2
Process Validation and Optimization
Project-related process validation and optimization your process based on critical process parameters and critical quality attributes
3
GMP Run
Large-scale cGMP manufacturing based on qualified process protocol
4
Aseptic Fill and Finish
Aseptic isolator under automatic class-A environment
5
Quality Control and Release
Whole process quality control and regulatory compliance, releasing and delivery of qualified products
6
Deliverables
Package including cell therapy product, Certificate of Analysis, batch production record, batch inspection record, etc.
Why OBiO?
10+ years of dedication to gene and cell therapy
Track record of >100 gene and cell therapy projects
Compliant manufacturing for successful initiation of multi-center clinical trials
Comprehensive quality system with regulatory compliant facilities
Sufficient capacity and state-of-the-art facilities for global manufacturing needs
End-to-end professional project management for in-time supports and on-time delivery
