Stability Comparison Between Microglassification and Lyophilization Using a Monoclonal Antibody.

Autor:	Chandrababu KB; Lindy Biosciences, 627 Davis Dr. #400 Morrisville, North Carolina 27560, United States., Kannan A; Pharmaceutical Development, Genentech Inc., South San Francisco, CA 94080, United States., Savage JR; Lindy Biosciences, 627 Davis Dr. #400 Morrisville, North Carolina 27560, United States., Stadmiller S; Lindy Biosciences, 627 Davis Dr. #400 Morrisville, North Carolina 27560, United States., Ryle AE; Lindy Biosciences, 627 Davis Dr. #400 Morrisville, North Carolina 27560, United States., Cheung C; Pharmaceutical Development, Genentech Inc., South San Francisco, CA 94080, United States., Kelley RF; Pharmaceutical Development, Genentech Inc., South San Francisco, CA 94080, United States., Maa YF; Pharmaceutical Development, Genentech Inc., South San Francisco, CA 94080, United States., Saggu M; Pharmaceutical Development, Genentech Inc., South San Francisco, CA 94080, United States. Electronic address: saggu.miguel@gene.com., Bitterfield DL; Lindy Biosciences, 627 Davis Dr. #400 Morrisville, North Carolina 27560, United States. Electronic address: dbitterfield@lindybio.com.
Jazyk:	angličtina
Zdroj:	Journal of pharmaceutical sciences [J Pharm Sci] 2024 Apr; Vol. 113 (4), pp. 1054-1060. Date of Electronic Publication: 2023 Oct 19.
DOI:	10.1016/j.xphs.2023.10.021
Abstrakt:	Producing solid-state formulations of biologics remains a daunting task despite the prevalent use of lyophilization and spray drying technologies in the biopharmaceutical industry. The challenges include protein stability (temperature stresses), high capital costs, particle design/controllability, shortened processing times and manufacturing considerations (scalability, yield improvements, aseptic operation, etc.). Thus, scientists/engineers are constantly working to improve existing methodologies and exploring novel dehydration/powder-forming technologies. Microglassification™ is a dehydration technology that uses solvent extraction to rapidly dehydrate protein formulations at ambient temperatures, eliminating the temperature stress experienced by biologics in traditional lyophilization and spray drying methods. The process results in microparticles that are spherical, dense, and chemically stable. In this study, we compared the molecular stability of a monoclonal antibody formulation processed by lyophilization to the same formulation processed using Microglassification™. Both powders were placed on stability for 3 months at 40 °C and 6 months at 25 °C. Both dehydration methods showed similar chemical stability, including percent monomer, charge variants, and antigen binding. These results show that Microglassification™ is viable for the production of stable solid-state monoclonal antibody formulations. Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Karthik Balakrishna Chandrababu – Stock options at Lindy Biosciences. Aadithya Kannan - None. John Savage – Stock options at Lindy Biosciences. Samantha Stadmiller – Stock options at Lindy Biosciences. Adam E. Ryle – Stock options at Lindy Biosciences. Chloe Cheung - None. Robert F. Kelley - None. Yuh-fun Maa - None. Miguel Saggu - None. Deborah L. Bitterfield – Board member and stock ownership at Lindy Biosciences. (Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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