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Quality assessment of LNP-RNA therapeutics with orthogonal analytical techniques.
Parot, Jeremie; Mehn, Dora; Jankevics, Hanna; Markova, Natalia; Carboni, Michele; Olaisen, Camilla; Hoel, Andrea D; Sigfúsdóttir, Margrét S; Meier, Florian; Drexel, Roland; Vella, Gabriele; McDonagh, Birgitte; Hansen, Terkel; Bui, Huong; Klinkenberg, Geir; Visnes, Torkild; Gioria, Sabrina; Urban-Lopez, Patricia; Prina-Mello, Adriele; Borgos, Sven Even; Caputo, Fanny; Calzolai, Luigi.
Afiliação
  • Parot J; Department of Biotechnology and Nanomedicine, SINTEF Industry, Trondheim, Norway.
  • Mehn D; European Commission, Joint Research Centre (JRC), Ispra, Italy.
  • Jankevics H; Malvern Panalytical Ltd., Worcestershire, UK.
  • Markova N; Malvern Panalytical Ltd., Worcestershire, UK.
  • Carboni M; Malvern Panalytical Ltd., Worcestershire, UK.
  • Olaisen C; Department of Biotechnology and Nanomedicine, SINTEF Industry, Trondheim, Norway.
  • Hoel AD; Department of Biotechnology and Nanomedicine, SINTEF Industry, Trondheim, Norway.
  • Sigfúsdóttir MS; Department of Biotechnology and Nanomedicine, SINTEF Industry, Trondheim, Norway.
  • Meier F; Postnova Analytics GmbH, Landsberg, Germany.
  • Drexel R; Postnova Analytics GmbH, Landsberg, Germany.
  • Vella G; Laboratory for Biological Characterisation of Advanced Materials (LBCAM), Trinity College Dublin, Ireland.
  • McDonagh B; Department of Biotechnology and Nanomedicine, SINTEF Industry, Trondheim, Norway.
  • Hansen T; Department of Biotechnology and Nanomedicine, SINTEF Industry, Trondheim, Norway.
  • Bui H; Department of Biotechnology and Nanomedicine, SINTEF Industry, Trondheim, Norway.
  • Klinkenberg G; Department of Biotechnology and Nanomedicine, SINTEF Industry, Trondheim, Norway.
  • Visnes T; Department of Biotechnology and Nanomedicine, SINTEF Industry, Trondheim, Norway.
  • Gioria S; European Commission, Joint Research Centre (JRC), Ispra, Italy.
  • Urban-Lopez P; European Commission, Joint Research Centre (JRC), Ispra, Italy.
  • Prina-Mello A; Laboratory for Biological Characterisation of Advanced Materials (LBCAM), Trinity College Dublin, Ireland.
  • Borgos SE; Department of Biotechnology and Nanomedicine, SINTEF Industry, Trondheim, Norway. Electronic address: SvenEven.Borgos@sintef.no.
  • Caputo F; Department of Biotechnology and Nanomedicine, SINTEF Industry, Trondheim, Norway; LNE - Centre for Scientific and Industrial Metrology, Trappes, France. Electronic address: fanny.caputo@gmail.com.
  • Calzolai L; European Commission, Joint Research Centre (JRC), Ispra, Italy. Electronic address: Luigi.CALZOLAI@ec.europa.eu.
J Control Release ; 367: 385-401, 2024 Mar.
Article em En | MEDLINE | ID: mdl-38253203
ABSTRACT
The availability of analytical methods for the characterization of lipid nanoparticles (LNPs) for in-vivo intracellular delivery of nucleic acids is critical for the fast development of innovative RNA therapies. In this study, analytical protocols to measure (i) chemical composition, (ii) drug loading, (iii) particle size, concentration, and stability as well as (iv) structure and morphology were evaluated and compared based on a comprehensive characterization strategy linking key physical and chemical properties to in-vitro efficacy and toxicity. Furthermore, the measurement protocols were assessed either by testing the reproducibility and robustness of the same technique in different laboratories, or by a correlative approach, comparing measurement results of the same attribute with orthogonal techniques. The characterization strategy and the analytical measurements described here will have an important role during formulation development and in determining robust quality attributes ultimately supporting the quality assessment of these innovative RNA therapeutics.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Ácidos Nucleicos / Nanopartículas Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Ácidos Nucleicos / Nanopartículas Idioma: En Ano de publicação: 2024 Tipo de documento: Article