Quality control

Quality control

Quality Control in Menarini Biotech certifies the quality of the manufacturing process according to GMP regulations, ensuring compliance with the correct analytical specifications and all quality standards. Our services include :

  • Management of viral and genetic characterization of cell banks
  • Stability studies and long-term storage of cell banks  (first or second storage site)
  • Analytical methods transfer 
  • ICH compliant method validation
  • Raw materials testing 
  • Analytical support during the manufacturing process through cleaning analysis and in process controls
  • Drug substance/Drug product release 
  • Stability testing performed according to ICH guidelines 


Our team is able to perform around 70 analytical techniques in a week using qualified instrumentation.

In addition, we are able to perform >50% of our analyses in a working day.

QC Analysis Timing