Abstract
AbstractThe topology and surface characteristics of lyophilisates significantly impact the stability and reconstitutability of freeze-dried pharmaceuticals. Consequently, visual quality control of the product is imperative. However, this procedure is not only time-consuming and labor-intensive but also expensive and prone to errors. In this paper, we present an approach for fully automated, non-destructive inspection of freeze-dried pharmaceuticals, leveraging robotics, computed tomography, and machine learning.
Funder
Friedrich-Alexander-Universität Erlangen-Nürnberg
Publisher
Springer Science and Business Media LLC
Reference53 articles.
1. Pikal MJ. Mechanisms of protein stabilization during freeze-drying storage: the relative importance of thermodynamic stabilization and glassy state relaxation dynamics. In: Freeze-drying/lyophilization of pharmaceutical & biological products. 3rd ed. CRC Press; 2010. p. 161–98.
2. Wang W. Lyophilization and development of solid protein pharmaceuticals. Int J Pharm. 2000;203:1–60.
3. Härdter N, Geidobler R, Presser I, Winter G. Microwave-assisted freeze–drying: Impact of microwave radiation on the quality of high-concentration antibody formulations. Pharmaceutics. 2023;15:2783.
4. Pardeshi SR, Deshmukh NS, Telange DR, Nangare SN, Sonar YY, Lakade SH, et al. Process development and quality attributes for the freeze-drying process in pharmaceuticals, biopharmaceuticals and nanomedicine delivery: a state-of-the-art review. J Pharm Innov. 2023. https://doi.org/10.1186/s43094-023-00551-8.
5. Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharm Res. 2010;27:544–75.