Bioproduct Research and Development, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Process Sciences, Seattle Genetics, Inc., 21823 30th Drive SE, Bothell, WA, 98021, USA.
Biologicals. 2020 Sep;67:9-20. doi: 10.1016/j.biologicals.2020.06.008. Epub 2020 Jul 11.
Identification of Critical Quality Attributes (CQAs) and subsequent characterization in process development studies are the key elements of quality by design (QbD) for biopharmaceutical products. Since the inception of ICH Q8R2, several articles have been published on approaches to conducting CQA risk assessments as well as the application to process understanding. A survey was conducted by multiple companies participating in an International Consortium working group on the best practices for identifying CQAs with linkages to process characterization (PC) studies. The results indicate that the companies surveyed are using similar approaches/timing to identify CQAs during process development. Consensus was also observed among the companies surveyed with approaches to linkage of CQAs to process characterization studies leading to impact to control strategies and lifecycle management.
在生物制药产品的质量源于设计（QbD）中，确定关键质量属性（CQAs）并在工艺开发研究中进行后续表征是关键要素。自 ICH Q8R2 发布以来，已经发表了多篇关于进行 CQA 风险评估的方法以及应用于工艺理解的文章。一个由多家参与国际联合会工作组的公司进行的调查，针对确定与工艺特性研究（PC）相关联的 CQAs 的最佳实践进行了调查。结果表明，接受调查的公司在工艺开发过程中采用类似的方法/时间来确定 CQAs。接受调查的公司在将 CQAs 与工艺特性研究联系起来的方法上也达成了共识，这将对控制策略和生命周期管理产生影响。
