Colin Carrie on Questions on the Order Paper

With regard to Health Canada’s review of the manufacturing data, quality control and safety of lipid nanoparticles (LNPs): (a) was the purity of the starting materials for the lipids, such as residual halogenated solvents and elements, including metals, assessed for mutagenic risk in accordance with established norms and guidelines, and, if so, what were the results, and, if not, why not; (b) was the total amount of observed impurities assessed for mutagenic risk, and, if so, what were the results, and, if not, why not; (c) were any individual element impurities considered mutagenic; (d) if the answer to (c) is affirmative, was this assessed with respect to multiple doses and with respect to the nature of transfection of the LNPs; (e) was any assessment of the LNP as a nanoparticle performed; (f) if the answer to (e) is affirmative, did this include an assessment of the PEG moiety; (g) was an assessment of the risk of complement activation-related pseudoallergy due to the PEG moiety performed, and, if so, what were the results, and, if not, why not; and (h) were any complement-related assays requested from the manufacturer, and, if not, why not?