Developing a Novel mRNA Manufacturing Platform with Sensible Biotechnologies

An in vivo alternative to conventional in vitro mRNA production technology

Today, we are pleased to announce our partnership with Sensible Biotechnologies to develop an in vivo microbial mRNA manufacturing platform. Currently, the vast majority of mRNA used in vaccines, therapeutics and other applications is produced by in vitro transcription (IVT), a cell-free process, which is driven by purified enzymes. In conventional mRNA manufacturing, production runs are typically limited in reaction volume size, and the resulting mRNA needs to go through expensive purification processes to eliminate potentially harmful byproducts like dsRNA, which can cause adverse immune responses in patients. Moreover, it is difficult to produce high yields of certain kinds of mRNA in an IVT reaction. By contrast, the in vivo mRNA manufacturing method that we are working to develop with Sensible is designed to scale upwards of 100,000L. The ultimate goal is to use  superior quality mRNA over traditional IVT- allowing for the production of mRNA molecules with increased length – and to expand the potential of the mRNA platform to novel therapeutic modalities.

Enabling the advent of novel mRNA medicines

“mRNA technology has a potential to bring many life-saving therapeutics and vaccines, but its current, cell-free production represents one of the major bottlenecks. In vivo mRNA manufacturing could enable scalable mRNA manufacturing, which has long relied on production methods that face quality control challenges and are inherently difficult to scale,” said Miroslav Gasparek, CEO at Sensible. “By working with Ginkgo, we aim to create a scalable commercial-grade manufacturing platform that produces mRNA of higher quality than is possible through in vitro expression and enable the advent of novel mRNA medicines.”

As the market for mRNA continues to expand, biopharma companies are looking for more efficient and scalable production platforms to produce high-quality mRNA. As we deepen our commitment to the emerging field of nucleic acid therapeutics, we are excited to work with the team at Sensible to optimize their microbial mRNA production platform with the goal of unleashing a new generation of mRNA products.

This partnership builds on our existing pipeline of mRNA-related programs, Including our work with Moderna to support process optimization for raw materials used to make mRNA vaccines. Furthermore, through our partnership with Aldevron, we optimized the production of vaccinia capping enzyme, an important component often required to manufacture mRNA vaccines and therapeutics. Most recently, we announced the acquisition of Circularis, a biotechnology company with a proprietary circular RNA and promoter screening platform, and is actively engaged in improving circular RNA efficacy and manufacturing yields.

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