We provide process development and cGMP manufacturing services for various oncolytic virus products including oncolytic adenovirus, herpes simplex virus, vaccinia virus, and vesicular stomatitis virus and new castle disease virus. Our flexible cGMP manufacturing platform can meet your manufacturing demands of different scales.
1
Virus Seed Stock Construction
Virus seed stock construction, identification, and stability studies for the oncolytic virus provided
2
Cell Bank Construction
Construction of primary, master, and working cell banks for adherent or suspension cell culture
3
Process and Analytical Method Development
Upstream process development, downstream process development, analytical method development, and formulation development
4
GMP Run - Upstream Process
Adherent or suspension cell culture with the developed method for specific type of oncolytic virus
5
GMP Run - Downstream Process
Automated and fully enclosed purification process, patented sterilization technology
6
Aseptic Fill and Finish
Aseptic isolator under automatic Class-A environment
7
Quality Control and Release
Quality control system in compliance with regulatory requirements
8
Deliverables
Package including oncolytic virus 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
Virus seed stock and cell banks transfer
Virus seed stock 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 oncolytic virus 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
