Company aims to discover and develop single-subunit RNA polymerases for efficient RNA manufacturing

The National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program, also known as America’s Seed Fund, has awarded Primordial Genetics, Inc, a synthetic biology company, a $224,693 grant to support the creation of innovative technologies that align with NIH’s mission to improve health and save lives. Primordial Genetics’ NIH award is supported by the National Institute of General Medical Sciences (NIGMS) of the National Institutes of Health.

A key objective of the SBIR program is to translate promising technologies to the private sector and enable life-saving innovations to reach consumer markets. Primordial Genetics’ work will focus on improved RNA manufacturing methods for RNA therapeutics. Progress in the development of RNA-based vaccines RNA therapeutics and RNA –based agricultural applications has created an unmet demand for inexpensive and efficient RNA manufacturing methods capable of generating large quantities (g to ktons) of pure, molecularly uniform RNA. Many applications are using chemical modifications that serve to increase RNA stability and efficacy. The commonly used RNA polymerases fall short of the requirements for such a manufacturing process, necessitating the development of novel RNA manufacturing enzymes that can incorporate non-natural nucleotides into RNA efficiently and with high fidelity.

In this project, Primordial Genetics aims to express, purify and characterize known, but so-far untested single-subunit RNA polymerases that can be developed into specialized RNA manufacturing enzymes. The company will test a suite of enzymes representing the natural diversity of bacteriophage RNA polymerases, for their ability to meet the critical requirements for in vitro RNA synthesis, including efficient, high-yield RNA synthesis, incorporation of non-natural nucleotides and high RNA quality.

This research is a feasibility study for isolating and developing novel enzymes suitable for RNA manufacturing, and also for creating an enzyme development pipeline that can meet the varied needs for manufacturing a diversity of RNA sequences, sizes and chemical structures represented in RNA vaccines and RNA therapeutic products under development.

The SBIR and Small Business Technology Transfer (STTR) programs are one of the largest sources of early-stage capital for technology commercialization in the United States. These programs allow US-owned and operated small businesses to engage in federal research and development that has a strong potential for commercialization.