在冷干燥中扩大控制核化:将真空诱导的表面结从实验室转化为良好的生产方法
Stefan C Schneid1, Michaela Cohrs1, Julian H Lenger1
1Bayer AG, Pharmaceuticals, CMC Drug Product, Friedrich-Ebert-Str. 475, Wuppertal 42117, Germany.
概括
使用真空诱导的表面结 (VISF) 控制的冰核化可以改善冷抗体配方的批量一致性. 这种技术确保了跨尺度均的冰形成,提高了产品的外观和工艺的可转移性.
科学领域:
- 制药科学 制药科学
- 化学工程是化学工程的重要组成部分.
- 生物技术是生物技术.
背景情况:
- 批量不均性和工艺转移问题在冷化的冷阶段出现.
- 瓶子和之间核化温度的变化使得一致的冰形成变得复杂.
研究的目的:
- 评估真空诱导表面结 (VISF) 对于控制的冰核的应用.
- 评估VISF用于从实验室到GMP制造的治疗抗体配方的可扩展性.
主要方法:
- 真空诱导的表面结 (VISF) 应用于治疗性抗体配方.
- 在实验室,试点和GMP规模的冷干燥机中转移了VISF过程.
- 化产品的质量属性和稳定性是特有的.
主要成果:
- 在没有设备修改的情况下,VISF在所有尺度上都成功实现了.
- 在压力控制和脱气方面,需要进行微小的规模依赖的调整,以实现均的核化.
- 使用VISF制造的产品呈现出更好的蛋糕外观,可能是由于结度效应的改变.
结论:
- VISF是一种可扩展和有效的控制冰核化技术,用于抗体配方.
- 该方法确保了产品质量的一致性,并提高了不同尺度的冷化过程的稳定性.
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