In-line Method Development for Vaccine Production
The safety and quality of vaccine products are an integral requirement for all vaccine manufacturing and production. Most current tests are using laboratory equipment that requires trained personnel, equipment qualification, method validation, manual sampling, and testing at various stages of product manufacturing. However, the off-line testing is slow, often requires significant volume of material for testing and requires extensive maintenance and upkeep of many different analytical instruments. This is both expensive and time consuming. On the other hand, Process Analytical Technology (PAT) provides fast turnaround time without the need for sampling, allowing manufacturing scientists opportunity to make real-time decisions to better ensure quality and consistency in product manufacturing. Furthermore, PAT provides a much faster vehicle for analytical assessment of manufacturing processes during product development, such as fermentation monitoring or protein purification.