Sensible Biotechnologies entered into a partnership with Ginkgo Bioworks to develop an in vivo microbial mRNA manufacturing platform.

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, according to Miroslav Gasparek, CEO at Sensible. 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, Gasparek continues, adding that it is difficult to produce high yields of certain kinds of mRNA in an IVT reaction.

By contrast, the in vivo mRNA manufacturing method Sensible and Ginkgo are working to develop is designed to scale to upwards of 100,000L, with the goal of superior quality mRNA over traditional IVT, allowing for the production of mRNA molecules with increased length and expanding the potential of the mRNA platform to novel therapeutic modalities, he explains.

Scaleable mRNA manufacturing

“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,” says Gasparek.

“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,” points out Austin Che, co-founder and head of strategy at Ginkgo Bioworks. “As Ginkgo deepens its commitment to the emerging field of nucleic acid therapeutics, we are excited to work with the team at Sensible Biotechnologies to optimize their microbial mRNA production platform with the goal of unleashing a new generation of mRNA products.”

The partnership with Ginkgo builds on Ginkgo’s pipeline of mRNA-related programs. Ginkgo worked with Moderna to support process optimization for raw materials used to make mRNA vaccines. In its partnership with Aldevron, Ginkgo optimized the production of vaccinia capping enzyme, an important component often required to manufacture mRNA vaccines and therapeutics, notes Che.

Ginkgo recently announced the acquisition of Circularis, a biotechnology company with a circular RNA and promoter screening platform.

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