The SAM (Self Amplifying) platform aims to revolutionize the way we prevent and treat infectious diseases by developing the next generation of best-in-class mRNA vaccines. The SAM platform represents a fully synthetic RNA vaccine technology combining a self-amplifying RNA backbone and a non-viral delivery system. While naked mRNA by itself is immunogenic, facilitated delivery is required to attain full potency. The delivery system is a cationic nanoemulsion (CNE), which binds to the SAM RNA, enables its delivery intra-cellularly and prevents degradation and thereby substantially increases the potency of the vaccine. The product is a two vial presentation one for the RNA drug product (DP) and the second for the CNE DP mixed at the patient’s bedside to yield the reconstituted vaccine. Unique challenges such as RNAase contamination, control strategy for novel raw-materials in an <i>in-vitro</i> transcription reaction to yield RNA and various others were encountered from a manufacturing perspective when advancing this novel platform. These challenges and mitigation strategies implemented to overcome them will be discussed. The end to end bio-manufacturing platform developed with this SAM platform presents a disruptive innovation to simplify vaccine discovery and development by providing an agile and robust CMC model for producing mRNA vaccines rather than specific antigen development which hinders a platform CMC approach.<br/>

Developing an end to end bio-manufacturing platform for the new paradigm of SAM (Self Amplifying mRNA vaccines)

255th National Meeting (2018)

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