Förklaring:

The instrument must use dynamic light scattering (DLS) to measure particle size accurately in the range 1 - 1000 nm, tocover the expected size range of our particles. The instrument must use static light scattering (SLS) together with DLS tomeasure particle concentration. This is required because our nanoparticle preparations will be injected in animals and theinjected dose must be precisely controlled. The instrument must perform measurements in standard SBS-format microwellplates (96, 384 and 1536 wells) compatible with standard multipipettes and automated pipetting robots. This is requiredbecause our upstream and downstream processing uses SBS-format standard microwell plates, which are flexible andavailable from multiple suppliers, as well as interoperable with best industry and clinical practices. The instrument mustcomplete the measurements of all wells in a 384-well plate in less than 90 minutes (with acceptable accuracy and precision),required because our nanoparticles may not be stable over longer periods which would lead to inaccurate measurements. Inaddition, the possibility to perform time-lapse experiments and temperature ramps to test the nanoparticle stability is alsorequired. The instrument must allow measurements in volumes from 5 μL to 150 μL, the range of volumes that fits the scaleof our nanoparticle productions. The instrument must use a near infrared laser with a wavelength longer than 820 nm inorder to avoid detecting sample autofluorescence, which can ruin measurements. The instrument and its software must havebeen conclusively shown to be applicable to our specific use-case scenario, measuring lipid nanoparticles, as evidenced by atleast five peer-reviewed publications by independent researchers. This is required because highly advanced optical detectorsare prone to unforeseen technical issues; since our lipid nanoparticle preparations will be injected in animals under stringentethical conditions, the measurement instrument must be robust, reliable, and accurate, which can only be proven throughsuccessful use by other researchers. Only one DLS instrument is compatible with all of these requirements which arenecessary to continue the project.

KI has applied Voluntary ex ante transparency.