AmplifyBio and RNAV8 Bio Announce Strategic Partnership to Support mRNA Therapeutic Developers from Sequence Design to GMP Manufacture

AmplifyBio, a Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) focused on differentiating services that cover target optimization, preclinical safety studies, and manufacturing scale-up, and RNAV8 Bio, an emerging startup focused on mRNA engineering platforms, are partnering to provide a one-stop shop for the development of mRNA therapeutics. The combined offering will be ideal for mRNA drug developers who require discovery and optimization with in silico, in vitro, and in vivo methods, preclinical manufacturing, and clinical GMP manufacturing for mRNAs. The end-to-end infrastructure will enable drug developers to rapidly prototype, test, iterate, winnow, and scale up their mRNA therapeutics.

“A key problem holding back mRNA from reaching its full therapeutic potential across rare and common diseases is the lack of streamlined infrastructure to bring therapeutic candidates more rapidly and efficiently to the clinic. Incumbents have resorted to building out their own mRNA design and manufacturing teams, albeit with limited tools at hand and a disjointed supply chain. There is often a steep challenge to find competent services and truly differentiating technology which can improve the probability of success for next-generation mRNA therapeutic and vaccine efforts,” said Devan Shah, CEO at RNAV8 Bio. RNAV8 Bio leverages rational design and ML/AI approaches to engineer desirable mRNA functions more deterministically.

The partnership will integrate RNAV8’s mRNA design and optimization expertise into AmplifyBio’s established preclinical CRO offering, process development, analytical development, and manufacturing capabilities. The result is a built-for-purpose mRNA development and scale up environment with discovery and design support rather than pieced together teams with limited tools and disjointed supply chains.

“AmplifyBio’s capabilities and expertise are strategically aligned to create a sandbox of tools, platforms, and SMEs that enable rapid iterative development and testing and are further integrated with our manufacturing infrastructure and capacity that was purpose-built for clients to grow into versus grow out of. We are particularly excited by the set of tools and capabilities that RNAV8 brings to our sandbox, and we look forward to engaging with our clients to create the next generation of mRNA therapeutics,” said J. Kelly Ganjei, CEO at AmplifyBio.

Together, this partnership creates a one-stop shop for mRNA sequence/chemistry engineering, in vitro performance screening, in vivo (diseased vs. healthy) model data generation, and mRNA production volumes ranging from micrograms to 100+ grams.

About RNAV8 Bio: 
RNAV8 Bio (pronounced “Renovate Bio”) utilizes rational design alongside machine learning and artificial intelligence techniques to engineer mRNA functions with greater predictability. Comprising a team of experts hailing from prominent backgrounds at Moderna, Pfizer, and Resilience, the company stands at the forefront of innovation in this field. Initial data indicates that RNAV8’s distinctive methodology has the potential to significantly enhance mRNA expression compared to prevailing industry standards. Consequently, the company has garnered partnership traction with leading biotechnology firms, showcasing the promising impact of their approach.

About Amplify Bio:
AmplifyBio is a contract research and manufacturing organization founded on the principle that all development and scale-up of advanced modality drugs should be done with commercial goals in mind. It was launched out of Battelle in 2021, with an initial offering of industry-leading preclinical toxicology, safety, and pharmacology testing in an agile environment with analytics capabilities that serve the dynamic safety requirements of modern modalities. Since then, AmplifyBio has developed drug characterization and optimization service capabilities and expertise based on the closely held principle that rich characterization, optimization, and data integrity are the keys to reproducibility and scale-up. The company then added GMP manufacturing, completing its concept-to-commercial service offering for the development of advanced therapies.

Source: AmplifyBio

About AmplifyBio

AmplifyBio is a preclinical CRO integrating next-gen technologies to accelerate the development of safe, efficacious therapies. Characterization and manufacturing services combined with safety studies enhance product knowledge and mitigate risks.

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