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
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 viral vector product, Certificate of
Analysis, batch production record, batch inspection
record, etc.
10+ years of dedication to gene and cell therapy
130 process development projects 230 analytical methods developed
Quality-driven team of experts with in-time responding
Efficient technology transfer with optimizing process validation
Process development versatility for various product needs stages
End-to-end regulatory support with side-by-side navigation
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