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@ARTICLE{Kolb:646210,
      author       = {Kolb, Bastian and Graewert, Melissa and Drexel, Roland and
                      Meier, Florian and Raab, Justin and Wilhelmy, Christoph and
                      Nawroth, Thomas and Soloviov, Dmytro and Haas, Heinrich and
                      Langguth, Peter},
      title        = {{A}dvanced {Q}uality and {C}omparability {A}ssessment of
                      m{RNA}-{L}oaded {L}ipid {N}anoparticles: {A}bsolute {S}ize
                      {D}istribution {P}rofiles and {S}tructure from
                      {AF}4-{C}oupled {L}ight and {X}-ray {S}cattering
                      {M}easurements},
      journal      = {Analytical chemistry},
      volume       = {xx},
      issn         = {0003-2700},
      address      = {Columbus, Ohio},
      publisher    = {American Chemical Society},
      reportid     = {PUBDB-2026-00755},
      pages        = {acs.analchem.5c05911},
      year         = {2026},
      abstract     = {The success of mRNA lipid nanoparticles (LNPs) used in the
                      COVID-19 vaccines has demonstrated the significance of
                      pharmaceutical products utilizing nanoparticle-based drug
                      delivery systems in global healthcare. For the assessment of
                      the safety, efficacy, and quality of these complex,
                      multicomponent systems, it is important to consider not only
                      the properties of the individual components but also their
                      colloidal organization. There is a need for standardized
                      methods to fulfill requirements for application in regular
                      quality control, providing information on these properties
                      in pharmaceutical products. To gain insight into size and
                      size-resolved quality attributes of LNPs, we apply
                      asymmetrical flow field-flow fractionation (AF4) coupled
                      in-line with synchrotron small-angle X-ray scattering (SAXS)
                      measurements, multiangle light scattering (MALS), and UV
                      absorption measurements. We propose model-free algorithms
                      for the analysis of light scattering and X-ray scattering
                      data to obtain quantitative size distribution profiles from
                      both methodologies. The approach is equally applicable for
                      SAXS and MALS data, but SAXS additionally provides detailed,
                      size-resolved insight into internal structure. Information
                      on various quality-indicating parameters for the
                      size-fractionated samples is obtained, including drug
                      loading, internal organization, and particle shape. Since
                      this approach does not require any model assumptions to
                      obtain structural, quality-indicative information from
                      experimental data, it is ideally suitable to evaluate the
                      comparability of results from different systems and
                      different laboratories. This makes it a valuable extension
                      to the regular quality control panel for pharmaceutical
                      nanoparticles, and it should be considered as a standard
                      method in the pharmacopoeias.},
      cin          = {EMBL-User / EMBL},
      ddc          = {540},
      cid          = {I:(DE-H253)EMBL-User-20120814 / I:(DE-H253)EMBL-20120731},
      pnm          = {6G3 - PETRA III (DESY) (POF4-6G3)},
      pid          = {G:(DE-HGF)POF4-6G3},
      experiment   = {EXP:(DE-H253)P-P12-20150101},
      typ          = {PUB:(DE-HGF)16},
      doi          = {10.1021/acs.analchem.5c05911},
      url          = {https://bib-pubdb1.desy.de/record/646210},
}