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Vaccine production in single-use technology: How to maintain closed system processing

Vaccine science has come a long way since Edward Jenner used pus to stop a child from catching smallpox. Synthetic, recombinant, and DNA vaccines have been developed to tackle various infectious diseases. Adoption of cell culture–based systems are also maturing, and vaccine manufacturers are beginning to leverage proven process technology from the broader biotechnology industry to enable multi-product manufacturing in an aseptic manufacturing environment. Single-use technology is one technology heavily adopted by the vaccine manufacturers to meet this requirement.

Maintaining processing system closure is one of the key elements of aseptic manufacturing. This presentation will examine key elements of a closed manufacturing system based on single use technology: integrity, bioburden and cleanliness, life cycle of use, boundary and material. Two case studies (final fill and cell cultivation) will be presented with attention given to the uniqueness of single use technology. Examples include use of sensitive integrity test methods such as helium integrity testing, relevance of single-use system shipping test to container closure, and maintenance of single use component design space.

Speaker:
Chor Sing Tan
Senior Single Use Technology Applications Leader, Cytiva

Chor Sing is the Senior Single Use Technology Applications Leader ay Cytiva. In this role, Chor Sing provides leadership and strategic guidance to the Bioprocess business. His main area of expertise is in adoption and implementation of single-use bioprocessing technologies, and he often acts as customer advocate in execution alignment.

Since joining Cytiva, Chor Sing has served in several business and science functions including sales, marketing and scientist roles in bioprocess technologies involving modular manufacturing solutions, bioreactors, chromatography, protein expression and filtration. Prior to joining Cytiva, Chor Sing was Senior Scientist and Bioprocess Engineer for CSL Behring with expertise in blood plasma processing.

Chor Sing received both his Ph.D. degrees in chemical and biomolecular engineering from the University of Melbourne, majoring in novel protein separation and biopolymer engineering.