开发人类免疫球蛋白的超高度配方,用于皮下注射
Jayprakash Yadav1, Shihab Uddin1, Francesco Civati1
1Department of Chemical Engineering, Massachusetts Institute of Technology, 77 Massachusetts Avenue, Cambridge, MA 02139-4307, United States.
Journal of pharmaceutical sciences
|February 5, 2025
概括
研究人员使用喷雾干燥粉末和制药辅助剂开发了高度的人类免疫球蛋白 (Ig) 悬浮剂. 这些新型配方证明了成功的注射性,即使在400毫克/毫升,为潜在的临床应用铺平了道路.
科学领域:
- 制药科学 制药科学
- 生物技术是生物技术.
- 蛋白质的配方 蛋白质的配方
背景情况:
- 由于粘度和可注射性问题,开发高度蛋白质疗法具有挑战性.
- 人体免疫球蛋白 (Ig) 是一种关键的治疗蛋白质,需要稳定和可管理的配方.
研究的目的:
- 开发和描述人类免疫球蛋白 (Ig) 的高度悬浮配方.
- 评估这些新型Ig配方的注射性和粘度.
- 探索超高度Ig的临床转换的可行性.
主要方法:
- 使用喷雾干燥来产生20μ以下的Ig颗粒.
- 通过将Ig粉末悬浮在含有辅助剂的和蛋白质溶液中,制备的体分散剂.
- 使用动态压缩测试和测量粘度的特征注入力.
主要成果:
- 获得高度Ig悬浮剂 (300-400 mg/mL) 与低聚合物含量 (0.3%).
- 在400mg/mL (16.5N力与24尺针),尽管高粘度 (284cP在380mg/mL) 证明成功注射.
- 配方显示了有希望的注射性参数,克服了非牛顿式,剪切加厚系统的典型挑战.
结论:
- 成功开发出稳定,高度的人类免疫球蛋白悬浮剂,具有良好的可注射性.
- 这些配方代表了潜在临床用途的重大进步,解决了粘度限制.
- 在临床应用之前,需要对化学稳定性和强制降解进行进一步的研究.
相关概念视频
Hybridoma Technology
14.0K
Hybridoma technology is used for the large-scale production of monoclonal antibodies. Monoclonal antibodies bind to only a single antigenic determinant or epitope. Such antibodies are used in research, diagnostics, and disease therapy. The hybridoma technology established in 1975 by Georges Köhler and Cesar Milstein was awarded the Nobel Prize in Medicine in 1984 for revolutionizing research and therapy.
Hybridoma Selection
Commonly used fusion techniques — electroporation,...
Hybridoma Selection
Commonly used fusion techniques — electroporation,...
14.0K
Insulin Formulations: Types and Delivery
162
Insulin preparations are categorized by their duration of action into short-acting and long-acting types. Two strategies are used to modify insulin's absorption and pharmacokinetic profile: slowing the absorption post-subcutaneous injection, or altering human insulin's amino acid sequence or protein structure. These changes retain the insulin's ability to bind to the insulin receptor, but alter its behavior in solution or after injection.
Short-acting insulins are divided into...
Short-acting insulins are divided into...
162


