| Popis: |
The manufacturing of veterinary viral vector vaccines follows the same principles of production of live veterinary vaccines. It includes upstream and downstream production of the active ingredient, as well as formulation, freeze-drying and/or packaging. The process development is key to allow robust production of high-quality, potent, safe and stable batches of vaccine at an acceptable cost. Potency test is generally based on virus titre, but additional specific analysis may be required to evaluate the potency of vector vaccines. Production processes of HVT, poxvirus and adenovirus vectors are summarized. Once the process and quality control are established for a particular vector vaccine, they can be reused for future products based on the same vector speeding up the process development and outline of production acceptance by the regulatory authorities. Process improvements include the use of continuous cell lines in suspension and in medium without substances of animal origin or chemically defined, using single-use technology, automatization, digitalization, data management and artificial intelligence. |
