Automated Metabolite Control for Bioprocesses in Vaccine Manufacturing
Programöversikt
- Continuous mid-infrared spectral data enables real-time monitoring and control of metabolites during bioprocess development. This study facilitated the transition from off-line to in-line technologies for in-process control.
- End-to-end automation of metabolite control was implemented in this study using PAT and PIMS; in-line mid-infrared probe with digital recording and feedback control.
- This reduced metabolite deviation by 20-fold and lead to significant improvements of drug substance yield by an order of magnitude.
Problem statement: manual control of metabolites during the development of fed-batch bioprocesses in stirred tanks is time consuming and often leads to poor bioprocess control and reduced yield.
A process analytical technology (PAT) was developed to continuously acquire the mid-infrared spectra of culture media in stirred tank reactors. This information was used to calculate the concentration of two key metabolites: glucose (carbon source) and glutamate (nitrogen source).
The continuous metabolite concentration data was transferred to the process information management system (PIMS) that enabled feedback loops and control of the feed pumps for improvements in bioprocess efficiency and significant improvements in drug substance yield.
About the Presenter
Jennifer Reid, PhD
Sanofi
Jennifer Reid is a Senior Scientist in the Drug Substance Development division of Sanofi Vaccines, based in Toronto Canada. She has a PhD in biochemistry based in stem cell biology and data science.
