CREATING CONFIDENCE

RESEARCH

Long term stability studies of native, lyophilised and inactivated viral standards

Stability of reference samples is the first requisite of standardization of viral NAT and serology. Our storage degradation studies at different temperatures performed over the last twenty years has provided the evidence that liquid frozen viral plasma standards are stable at -80˚C but not always at -30˚C (depending on the nature of the viral standard). Also accelerated stability studies in the liquid phase at 4, 21 and 37˚C has given us insight in the degradation kinetics of different viral standards. The research showed that lyophilisation destroys viral particles and is a more harsh treatment than pasteurization at low protein concentration. Freeze drying does not always guarantee stability of viral standards at -20˚C. Lyophilisation is not a reproducible process and because of batch size limitations introduces a risk of calibration issues with replacement standards. This can be avoided by making use of our system of consistent preparation of liquid frozen standard dilutions for validation and quality control of IVDs.

Read more in this overview of our stability (and viral particle integrity) studies (PDF).