Three-Dimensional Homodyne Light Detection (3D-HLD) for High-Throughput Submicron Particle Analysis in (Highly Concentrated) Protein Biopharmaceuticals, Viral Vectors, and LNPs.

Autor:	Brandstetter D; Coriolis Pharma Research GmbH, Fraunhoferstr. 18 b, 82152 Martinsried, Germany., Helbig C; Coriolis Pharma Research GmbH, Fraunhoferstr. 18 b, 82152 Martinsried, Germany., Osawa K; Hitachi High-Tech Corporation 1-17-1 Toranomon, Minato-ku, Tokyo 105-6409, Japan., Minemura H; Hitachi, Ltd., Research & Development Group, 1-280 Higashi-koigakubo, Kokubunji-shi, Tokyo 185-8601, Japan., Anzai Y; Hitachi, Ltd., Research & Development Group, 1-280 Higashi-koigakubo, Kokubunji-shi, Tokyo 185-8601, Japan., Torisu T; Department of Biotechnology, Graduate School of Engineering, Osaka University, 2-1 Yamadaoka, Suita, Osaka 565-0871, Japan., Uchiyama S; Department of Biotechnology, Graduate School of Engineering, Osaka University, 2-1 Yamadaoka, Suita, Osaka 565-0871, Japan; U-Medico Inc. 2-1 Yamadaoka, Suita, Osaka 565-0871, Japan., Menzen T; Coriolis Pharma Research GmbH, Fraunhoferstr. 18 b, 82152 Martinsried, Germany., Friess W; Department of Pharmacy, Ludwig-Maximilians-Universität München, Pharmaceutical Technology and Biopharmaceutics, Butenandtstr. 5-13, 81337 Munich, Germany., Hawe A; Coriolis Pharma Research GmbH, Fraunhoferstr. 18 b, 82152 Martinsried, Germany. Electronic address: Andrea.Hawe@coriolis-pharma.com.
Jazyk:	angličtina
Zdroj:	Journal of pharmaceutical sciences [J Pharm Sci] 2024 Apr; Vol. 113 (4), pp. 891-899. Date of Electronic Publication: 2023 Nov 03.
DOI:	10.1016/j.xphs.2023.10.042
Abstrakt:	During biopharmaceutical development, particle monitoring and characterization are crucial. Notably, particles can be impurities considered as critical quality attribute, or active pharmaceutical ingredient (e.g., viral vectors) or drug delivery system (e.g., lipid nanoparticles) itself. Three-dimensional homodyne light detection (3D-HLD) is a novel technique that can characterize particles in the ∼0.2 µm to 2.0 µm size range. We evaluated 3D-HLD for the analysis of high concentration protein formulations (up to 200 mg/mL), where formulation refractive index and background noise became limiting factors with increasing protein concentration. Sample viscosity however did not impact 3D-HLD results, in contrast to comparative analyses with NTA and MRPS. We also applied 3D-HLD in high-throughput screenings at high protein concentration or of lipid nanoparticle and viral vector formulations, where impurities were analyzed in the presence of a small (<0.2 µm) particulate active pharmaceutical ingredient. 3D-HLD turned out to be in good agreement with or a good complement to other state-of-the-art particle characterization techniques, including BMI, MRPS, and DLS. The main application of 3D-HLD is high-throughput particle analysis at low sample volume. Follow-up investigation of the optimized particle sizing approach and of detection settings could further improve the understanding of the method and potentially increase ease of operation. Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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