Challenges in monitoring the quality of vaccine production
Process Analytical Technology (PAT) ensures process reproducibility in bioprocessing
- A mechanism to design, analyze and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect product quality attributes (CQA)
- Initiated by the FDA as part of the 21st Century GMP initiative in 2001 with the goal of increasing productivity
- In addition, application of PAT in vaccine development and manufacturing is challenging. This can be due to the sample complexity and batch-to-batch variability.
- The development of an up- and/or down-stream process of the target biomolecule requires a fast, accurate and reliable analytical method. Therefore, this can determine the quantity and purity of the product intended for human use.
Solution: Convective Interaction Media Monoliths from BIA Separations
- Monoliths are chromatography media cast as a single block, inserted into a housing
- Highly inter-connected network of channels (1-2 μm) containing functionalised binding sites for large biomolecules (viruses, VLPs, pDNA, antibodies)
- Additionally, performance unaffected by increasing the flow rate or molecular size