Formulation machine

As a first step towards evaluating the use of RNA vaccines for livestock, the Centre for Veterinary Vaccine Innovation and Manufacturing (CVIM) collaborated ) to carry out a proof-of-principle study. The success of this work has led to the continued evaluation by CVIM of RNA-based vaccines for livestock. To facilitate the continued evaluation of RNA-based vaccines for livestock CVIM needs to develop the capacity to produce formulated mRNA vaccine candidates at a suitable scale to carry out in vivo immunogenicity studies. A machine to encapsidate RNA is required to produce formulated mRNA vaccines. A suitable formulation machine needs to: • Be compact (small footprint) to enable its location in existing CVIM R&D facilities. • Enable application of Good Laboratory Practice • Have seamless scalability to enable higher levels of production at good manufacturing practice (GMP, to meet regulatory compliance). • Be capable of encapsidating mRNA of differing complexity using different LNP formulations. • Be user-friendly (reduced training requirements and user error). • Provide a protective environment for products (low bioburden). • Produce suitable volumes (capacity to support in vivo studies). • Compatible with existing and collaborator's equipment to enable the transfer of reagents and methods. Specifically, the encapsidation machine needs to be compatible to our recently purchased Ntensify Mini (RNA producing machine).