Sensible Biotechnologies and Ginkgo Bioworks team up on novel mRNA manufacturing platform
The vast majority of mRNA used in vaccines, therapeutics and other applications is currently produced by in vitro transcription (IVT), a cell-free process, which is driven by purified enzymes. However, the companies highlight that this process has a number of limitations.
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 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,” say the companies.
Enabling the advent of novel mRNA medicines
Based in Oxford, UK and Bratislava, Slovakia, Sensible Biotechnologies says addressing the weaknesses in in vitro transcription is key to unleashing the potential of mRNA.
"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," said Miroslav Gasparek, CEO, Sensible. "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.
"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."
Boston, Massachusetts headquartered Ginkgo provides a horizontal platform for cell programming: and already has a pipeline of mRNA-related programs as the technology gathers pace.
"As the market for mRNA continues to expand, biopharma companies are looking for more efficient and scalable production platforms to produce high-quality mRNA," explained Austin Che, co-founder and Head of Strategy at Ginkgo Bioworks.
Its pipeline of mRNA-related programs includes a project with Moderna to support process optimization for raw materials used to make mRNA vaccines; and a partnership with Aldevron to optimize the production of vaccinia capping enzyme (an important component often required to manufacture mRNA vaccines and therapeutics).
In October, Ginkgo announced the acquisition of Circularis, a biotechnology company with a proprietary circular RNA and promoter screening platform: strengthening its capabilities in cell and gene therapy.