生物结合
化学
过程分析技术
过程(计算)
结合
生物过程
过程开发
监测和控制
多糖
原位
肺炎链球菌
组合化学
纳米技术
生化工程
色谱法
生物化学
工艺工程
有机化学
化学工程
计算机科学
数学分析
控制工程
材料科学
工程类
抗生素
操作系统
数学
作者
Justin P. Lomont,Nicole M. Ralbovsky,Christine Guza,Anumita Saha-Shah,Joseph Burzynski,Janelle Konietzko,Sheng-Ching Wang,Patrick McHugh,Ian Mangion,Joseph P. Smith
标识
DOI:10.1016/j.jpba.2021.114533
摘要
Pneumococcal conjugate vaccines (PCVs) are formed by bioconjugation of a carrier protein to the purified capsular polysaccharide (Ps) from multiple serological strains of Streptococcus pneumoniae. The associated bioconjugation chemistry relies on initial selective modifications to the Ps backbone structure. Among these modifications, removal of a ketal functional group, termed deketalization, is one that is important for pharmaceutical PCV production. Herein, we report a process monitoring investigation into the deketalization of a polysaccharide relevant to PCV process development. We have applied process analytical technology (PAT) for in situ process monitoring to study the deketalization reaction in real time. We find that in situ FTIR spectroscopy elucidates multiple classes of reaction kinetics, one of which correlates strongly with the deketalization reaction of interest. This PAT approach to real time reaction monitoring offers the possibility of improved process monitoring in the pharmaceutical production of PCVs. To our knowledge, this report represents the first PAT investigation into Ps deketalization. Our findings suggest that broader application of PAT to the chemical modifications associated with PCV bioconjugation, as well as other pharmaceutically relevant bioconjugation processes, carries the power to enhance process understanding, control, and efficiency through real time process monitoring.
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