PDF file: 441-3090_LNPs_non_answer.pdf
OPQ ID: 441-3090
Session: 441
Question number: Q-3090
Sessional paper: Q-3090
Title: LNPs non-answer
Short description: 
Topic: public health
Identified concern: 
Keywords: 
Agencies: HC
Date asked: 2024-10-21
Date tabled: 
Submitted by: Mr. Carrie (Oshawa)
Reply by: Minister of Health
Responded by: Mr. Yasir Naqvi
Pages: 2
Status: not processed
Alert: yellow
Questions asked: 8
Questions answered: 1
Percent responded: 12%
Referenced sources: (none extracted)
Referenced links: (none extracted)
Official link: https://www.google.com/search?q=Q-3090+ourcommons.ca
PDF URL: https://ivim.ca/foi/opq/r/441-3090_LNPs_non_answer.pdf
TXT URL: https://ivim.ca/foi/opq/r/441-3090.txt
Original filename: Q-3090_HC, LNPs non-answer.pdf
Local source path: C:\Users\Dmitry\Documents\CODES\OPQ-App\data-raw\OPQ\ALL OPQ TO DATE\2022\Q-3090_HC, LNPs non-answer.pdf
Machine extracted at: 2026-06-30 12:58:28

References / links:
(none extracted)

Machine notes:
(none)

Question text preview:
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?