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$60M Challenge Seeks RNA Bio-Production Network

Gene therapy graphic

(Genome Research Limited, Flickr)

14 July 2021. A new challenge competition aims to build a distributed network of facilities to design, develop, and manufacture RNA-based biologic products. The challenge, with a total prize purse of $60 million, is sponsored by Wellcome Leap, a research and development funding organization in Los Angeles that encourages breakthrough medical technologies at a faster pace than conventional processes.

The R3 competition, short for RNA readiness and response, seeks to create more facilities for producing RNA pharmaceuticals, which Wellcome Leap says are now limited to only a few biopharmaceutical companies. Because of the still-novel technology, large investments are needed to build the few existing custom-made RNA manufacturing plants, which keeps new participants from joining the market and limits innovations in the field.

Wellcome Leap and CEPI, short for Coalition for Epidemic Preparedness Innovations based in Oslo, Norway, a cosponsor of the challenge, aim to break this paradigm using the semiconductor industry as a model. Before the late 1970s, semiconductor circuits were designed and fabricated as custom-made items to perform specific functions by a few large data machine manufacturers, conditions similar to RNA manufacturing today.

Since then, say the organizations, advances in very large-scale integration enabled separation of circuit design from fabrication, vastly expanding the pool of circuit designers, and allowing many more types of circuits to be created. Soon thereafter, new companies emerged concentrating on design, while other semiconductor foundries specialized only in fabrication. These developments, say the R3 sponsors, made possible double-digit compound annual growth in the semiconductor industry.

Three levels of solutions over three years

The R3 challenge seeks to expand the number biologic products made from RNA as well as create a distributed network of RNA-based product manufacturers with the capacity to quickly expand production in response to the next pandemic. To meet these goals, demonstrations at three solution levels are expected from participants, over a three-year period.

First, standardized RNA production processes are needed to generate a wide range of biologic products from pharmaceuticals like monoclonal antibodies and vaccines, to diagnostics, and non-medical products such as pesticides and fragrances. These processes should be based on software for design and simulation of RNA-based products, flexible multi-product manufacturing processes that meet current Good Manufacturing Practice standards, and brokerage services to connect designers to manufacturers.

The second R3 level, builds on the first set of processes to increase the number, diversity, and pace of biologics development. In this phase of the competition, participants should demonstrate solutions that enable reduced dosages, broaden the range of targets to non-viral health issues such as antibiotic-resistant bacteria, optimize performance of antibodies derived from messenger RNA to lengthen their activity in the body and reduce their cost, and devise delivery mechanisms other than needles, such as transdermal patches or nasal sprays.

The third R3 level integrates processes and solutions from the first two levels into working RNA foundries. The foundries need to show they can manufacture a wide range of products under normal conditions, and balance simultaneous production of multiple RNA products, yet shift into high-volume production to meet emergencies like a global pandemic. In addition, participants need to demonstrate an ability to produce RNA biologics in multiple locations.

The competition has a total prize purse of $60 million, but numbers and sizes of awards will depend on the proposals received and work selected for funding. The first deadline for proposal abstracts is 13 Aug., with entries accepted beginning on 6 Aug. Feedback on abstracts is provided on 27 Aug., with full proposals due on 27 Sept. Teams from academic labs, government labs, research institutes, not-for-profit organizations, and companies of all sizes may take part. Participants may initially propose solutions for parts of the challenge, with Wellcome Leap bringing together participants later on to integrate their solutions.

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