Orthogonal analytical insights from RNA drug substances to lipid nanoparticle drug products

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Davidson, Callum G. and Kapsali, Eleni and Perrie, Yvonne and Rattray, Zahra (2025) Orthogonal analytical insights from RNA drug substances to lipid nanoparticle drug products. In: 16th PharmSci International Conference, 2025-09-09 - 2025-09-11, Principality Stadium.

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Abstract

• Polyadenylic acid (Poly(A)) has emerged as a popular choice for use as a model RNA drug substance for LNP formulation prototyping. • In the absence of existing RNA and LNP drug substance/drug product reference materials, Poly(A)-LNPs are widely used as a control formulation to assess the impact of manufacturing process parameters on formulation critical quality attributes (CQAs). • Since the stability of RNA drug substance (DS) cargo is a major determinant of drug product (DP) performance, both pre-formulation and post-formulation attributes of the RNA must be assessed thus highlighting the need for systematic comparison of DS quality and its effect on DP formulation. • This study aims to enhance knowledge of model Poly(A) critical quality attribute impact on LNP formulation attributes, ultimately seeking to produce better standardised controls for LNP bench to bedside translation.

ORCID iDs

Davidson, Callum G. ORCID logoORCID: https://orcid.org/0009-0003-8736-9918, Kapsali, Eleni, Perrie, Yvonne ORCID logoORCID: https://orcid.org/0000-0001-8497-2541 and Rattray, Zahra ORCID logoORCID: https://orcid.org/0000-0002-8371-8549;
CORE (COnnecting REpositories)