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.
• 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.
| Original language | English |
|---|---|
| Number of pages | 1 |
| Publication status | Published - 8 Sept 2025 |
| Event | 16th PharmSci International Conference - Principality Stadium, Cardiff, United Kingdom Duration: 9 Sept 2025 → 11 Sept 2025 https://apsgb.co.uk/pharmsci-2025/ |
Conference
| Conference | 16th PharmSci International Conference |
|---|---|
| Abbreviated title | PharmSci 2025 |
| Country/Territory | United Kingdom |
| City | Cardiff |
| Period | 9/09/25 → 11/09/25 |
| Internet address |
Funding
We acknowledge funding from EPRSC (EP/V028960/01) Multiscale Metrology Suite for next-generation health nanotechnologies. We acknowledge and thank EPRSC for funding my PhD scholarship
Keywords
- Poly(A)
- lipid nanoparticle
- analytics
- translation