With process development and cGMP manufacturing services for viral vectors including adeno-associated virus and lentivirus, we can flexibly adjust to adherent or suspension-based platform to meet your manufacturing demands.
1
Cell Bank Construction
Construction of primary, master, and working cell banks for adherent or suspension cell culture
2
Process and Analytical Method Development
Upstream process development, downstream process development, analytical method development, and formulation development
3
GMP Run - Upstream Process
Adherent or suspension cell culture with the developed method for specific type of viral vector
4
GMP Run - Downstream Process
Automated and fully enclosed purification process, patented sterilization technology
5
Aseptic Fill and Finish
Aseptic isolator under automatic Class-A environment
6
Quality Control and Release
Quality control system in compliance with regulatory requirements
7
Deliverables
Package including viral vector product, seed bank, Certificate of Analysis, batch production record, batch inspection record, and relevant Chemistry Manufacturing and Control (CMC) dossier
Development and Manufacturing at Post-IND stage
7
1
Bank Transfer
Cell bank transfer, gap analysis, and technology transfer report
2
Process Transfer and Scale-up
Project-related process transfer; or further process scaling-up
3
Process Validation and Optimization
Project-related process validation and optimization your process based on critical process parameters and critical quality attributes
4
GMP Run
Large-scale cGMP manufacturing based on qualified process protocol
5
Aseptic Fill and Finish
Aseptic isolator under automatic class-A environment
6
Quality Control and Release
Whole process quality control and regulatory compliance, releasing and delivery of qualified products
7
Deliverables
Package including viral vector 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
