An Industry Perspective on the Use of Novel Excipients in Lipid Nanoparticles—Nonclinical Considerations DOI Creative Commons
Lorrene A. Buckley, Jessica E. Sutherland,

Prachi Borude

et al.

International Journal of Toxicology, Journal Year: 2025, Volume and Issue: unknown

Published: March 4, 2025

Nucleic acid drug delivery with lipid nanoparticle (LNP) formulations has enabled the development of novel therapeutics and vaccines. LNP are composed both naturally occurring synthetic excipients. This perspective shares current practices in nonclinical safety assessment excipients contained identifies gaps regulatory guidance on this topic. There is no globally harmonized for or specific to testing LNPs. Given complexity these formulations, most studies support conducted product a that contains non-active cargo. Three case (Onpattro®, Comirnaty®, SpikeVax®) highlight assessments may differ depending encapsulated modality, intended use (e.g., therapeutic versus preventative vaccine), dose, frequency dosing. These also suggest agencies open scientific rationale justify why certain tests should not be performed. As more products approved, it will important understand how precedents set approved can leveraged what additional unique strategies applied ensure predictive, relevant, meaningful human safety. Proactive alignment authorities critical context, especially as new approaches proposed. Guidance documents need revised created experience acquired reflect considerations

Language: Английский

Advances in Starch-Based Nanocomposites for Functional Food Systems: Harnessing AI and Nuclear Magnetic Resonance Technologies for Tailored Stability and Bioactivity DOI Creative Commons
Yue Sun, Ziyu Wang,

Jian Ye

et al.

Foods, Journal Year: 2025, Volume and Issue: 14(5), P. 773 - 773

Published: Feb. 24, 2025

Starch-based nanocomposites (SNCs) are at the forefront of innovations in food science, offering unparalleled opportunities for enhancing stability, bioactivity, and overall functionality systems. This review delves into potential SNCs to address contemporary challenges formulation, focusing on synergistic effects their components. By integrating cutting-edge technologies, such as artificial intelligence (AI) nuclear magnetic resonance (NMR), we explore new avenues precision, predictability, SNCs. AI is applied optimize design SNCs, leveraging predictive modeling fine-tune material properties streamline production processes. The role NMR also critically examined, with particular emphasis its capacity provide high-resolution structural insights, monitor stability over time, elucidate molecular interactions within matrices. Through detailed examples, highlights impact unraveling complex behaviors bioactive compounds encapsulated Additionally, discuss integration functional assays AI-driven analytics assessing bioactivity sensory these systems, providing a robust framework rational advanced products. synergy between AI, NMR, opens pathways developing tailored, high-performance formulations that both health consumer preferences.

Language: Английский

Citations

0
An Industry Perspective on the Use of Novel Excipients in Lipid Nanoparticles—Nonclinical Considerations DOI Creative Commons
Lorrene A. Buckley, Jessica E. Sutherland,

Prachi Borude

et al.

International Journal of Toxicology, Journal Year: 2025, Volume and Issue: unknown

Published: March 4, 2025

Nucleic acid drug delivery with lipid nanoparticle (LNP) formulations has enabled the development of novel therapeutics and vaccines. LNP are composed both naturally occurring synthetic excipients. This perspective shares current practices in nonclinical safety assessment excipients contained identifies gaps regulatory guidance on this topic. There is no globally harmonized for or specific to testing LNPs. Given complexity these formulations, most studies support conducted product a that contains non-active cargo. Three case (Onpattro®, Comirnaty®, SpikeVax®) highlight assessments may differ depending encapsulated modality, intended use (e.g., therapeutic versus preventative vaccine), dose, frequency dosing. These also suggest agencies open scientific rationale justify why certain tests should not be performed. As more products approved, it will important understand how precedents set approved can leveraged what additional unique strategies applied ensure predictive, relevant, meaningful human safety. Proactive alignment authorities critical context, especially as new approaches proposed. Guidance documents need revised created experience acquired reflect considerations

Language: Английский

Citations

0