Real-time in situ monitoring of CRM-197 and polysaccharide conjugation reaction by fluorescence spectroscopy: supplementary figures

Aims: Process analytical technology (PAT) is increasingly being adopted within the pharmaceutical industry

to build quality into a process. Development of PAT that provides real-time in situ analysis of critical quality

attributes are highly desirable for rapid, improved process development. Conjugation of CRM-197 with

pneumococcal polysaccharides to produce a desired pneumococcal conjugate vaccine is a significantly

intricate process that can tremendously benefit from real-time process monitoring. Methods: In this work,

a fluorescence-based PAT methodology is described to elucidate CRM-197-polysacharide conjugation

kinetics in real time. Results & conclusion: In this work, a fluorescence-based PAT methodology is described

to elucidate CRM-197-polysacharide conjugation kinetics in real time.