DOI: 10.3390/analytica7040071 ISSN: 2673-4532

Analysis of Heterogeneous Biological Preparations in Turbid Media: Limitations of Standard Methods and a Proof-of-Concept Evaluation of Diffuse Reflectance Kinetics

Anton V. Syroeshkin, Tatiana V. Grebennikova, Tatiana V. Pleteneva, Olga V. Levitskaya, Daria A. Galkina, Gleb V. Petrov, Ainaz Safdari, Tatiana E. Savochkina, Dimitriy Yu. Yakunin, Ilya I. Yudin, Elena V. Uspenskaya

(1) Background: Turbid biological formulations present a challenge for conventional optical protein analysis because scattering and particulate heterogeneity can distort analytical signals. (2) Methods: This study evaluated the limitations of ultraviolet–visible spectroscopy, intrinsic fluorescence, and dynamic light scattering for heterogeneous protein-containing systems and explored diffuse reflectance kinetics (DRK) as a non-destructive complementary approach. Bovine serum albumin model systems with and without particulate components were used to assess matrix-related effects, while a squalene-adjuvanted virus-like particle (VLP) formulation was investigated as a representative turbid biopharmaceutical system. DRK analysis was based on time-resolved diffuse-reflectance image sequences and numerical descriptors of spatiotemporal scattering dynamics. (3) Results: Conventional optical methods were strongly affected by turbidity, whereas selected DRK descriptors showed a concentration-dependent response in a squalene-containing emulsion matrix and acceptable repeatability under the investigated conditions. The results support the potential of DRK for comparative monitoring of apparent protein-related changes in turbid biological preparations. (4) Conclusions: Further validation using independent final vaccine batches and orthogonal reference methods is required before DRK can be considered for quantitative protein determination.