Avirmax CDMO Services Include (but are not limited to)
Process Development Pre-Clinical Early-Phase Clinical Late-Phase Clinical & Commercial
Avirmax CDMO Services Include
(but are not limited to)
Generation of Baculovirus Research and Master Viral Banks
Generate initial viral banks using client’s gene of interest and REP/CAP
Generation of Research and Master Cell Banks
Generate research and master cell banks at client’s request
Evaluation of Baculovirus Research and Master Viral Banks
- Small-scale studies in shaker flasks to assess AAV production containing client’s GOI and capsid of choice
- Optimization of upstream and downstream process in stir vessel bioreactors and identification of critical process parameters
- Testing for baculovirus and AAV production
- PD scale-up of optimized process in stir tank bioreactor
Analytical Assay Transfer, Development & Qualification
AAV viral genome quantitation by qPCR, AAV infectious titer assay (TCID50), host cell protein ELISA and DNA, capsid/gene copy ratio, determination of DNA contaminants in AAV samples using Next Generation Sequencing (NGS), purity by SDS PAGE, identity of AAV by Western Blot, OD 260/280, baculovirus titer by qPCR or droplet digital PCR (ddPCR), bioburden, endotoxin
cGMP Scale-Up
- Production of materials for GLP toxicology studies up to 200L scale
- cGMP production for Phase I, II and III Investigations
Formulation Development & Stability
- Formulation Development available
- Stability protocol development and stability studies
Fill & Finish
- Performed in ISO 5 area using aseptic filling equipment and size/volume as determined by client
- Vials will be subject to visual inspection and stored at ≤ – 60°C
Viral Clearance Validation
Dedicated and robust virus inactivation technologies