Vivek Vaidya, Snehal Agnihotri, Rajeev Dhere, Ravindra Muley, Sanjay Patil, Amit Patil, Arvind Panse

Trypsin is a proteolytic enzyme routinely used as an effective cell dissociating agent in tissue culture based viral vaccine manufacturing processes. Conventionally a porcine or bovine origin trypsin is used for this purpose. Being an animal origin material, it can potentially contaminate the final product by known or unknown adventitious agents inherent in the source material. Animal-derived materials are now subject to more stringent regulations. Therefore, it is essential to design production processes in such a way, that they offer maximum viral clearance potential from animal origin products. Use of animal-component-free recombinant trypsin appears to be a viable alternative for the animal origin trypsin. Two types of commercially available recombinant trypsins were selected for evaluation purpose in comparison with conventional porcine-origin trypsin. All the three trypsin preparations were used for serial passaging of human diploid (MRC-5) cells, and subsequent manufacturing of Measles and Rubella vaccine using above substrates. In conclusion, both the recombinant trypsin samples were found to be equivalent to conventional porcine trypsin with respect to important parameters viz. cell culture suitability and yield of Measles and Rubella viruses.