PDF
Full
Outline
To explore the feasibility of multivariate data analysis (MVDA) in formulation robustness study of biopharmaceutical drug products by taking an antibody-drug conjugate (ADC) HS630 as example.
A two-level fractional factorial design with five factors was used to investigate the effects of protein content, contents of three excipients and pH on critical quality attributes. After preparation, the samples of each group were exposed to high temperature for 28 d and light for 10 d, respectively. The contents of polymers and free DM1 were detected and analyzed.
Partial least squares (PLS) method was used for model fitting and data analysis, and the model seemed good with an acceptable predictive capability. All the excipients and pH had no significant effect on the contents of polymers and free DM1. Although it was not significant, a higher free DM1 content was noticed with higher protein content and higher pH conditions. Light and high temperature had significant effects on the attributes of drug product with a similar trend but small ranges. The formulation in the studied range was regarded as robust.
Taking MVDA method into formulation robustness study of drug products can analyze the multi-dimensional data obtained under different treatment conditions. The critical components of the formulation can be identified, and the influence of treatment conditions on the critical quality attributes can be investigated.
PDF
33
12
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
关闭全屏
No. 86 Xueyuan South Road, Haidian District, Beijing
010-62199257
qkjq@cast.org.cn
Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House
