Avirmax Inc

Services

Avirmax CDMO Services Include (but are not limited to)

Process Development      Pre-Clinical      Early-Phase Clinical      Late-Phase Clinical & Commercial
Generation of Viral Banks
0%
US & DS Process Development
0%
Analytical Dev
0%
cGMP Scale-up
0%
Process Qualification & Validation
0%
Stability Studies
0%
Stability Studies
0%
Fill & Finish
0%
Virus Validation
0%

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