Our range of technical capabilities for oncolytic viruses include:
Comprehensive upstream and downstream processing
Upstream development services such as cell line evaluation, media and feeds evaluation, production vessel evaluation
Optimization of virus production parameters (e.g. MOI, POI and POH)
Development of virus harvest strategy and purification process
Downstream development covering lysis, nuclease digest, clarification, crossflow filtration, chromatography and sterile filtration
Lyophilization services for oncolytic viruses supported by excipient screening and formulation development expertise
Assay development including identity, potency, process residuals, contaminants, and physico-chemical properties
Assay qualification and validation
Analytical testing of batches
An extensive list of release assays for identity, potency, purity, and safety executed by our QC department or selected third parties in line with International Conference on Harmonisation (ICH) Q2 (R1) requirements
Fill and finish of drug product and placebo/buffer (automatic and manual)