Stability Comparison Between Microglassification and Lyophilization Using a Monoclonal Antibody.
J Pharm Sci
; 113(4): 1054-1060, 2024 Apr.
Article
en En
| MEDLINE
| ID: mdl-37863428
ABSTRACT
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.
Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Productos Biológicos
/
Química Farmacéutica
Límite:
Humans
Idioma:
En
Revista:
J Pharm Sci
Año:
2024
Tipo del documento:
Article
País de afiliación:
Estados Unidos