Avirmax CMC

Avirmax CDMO Services Include (but are not limited to)

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

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