The partnership between Sensible Biotechnologies and Ginkgo Bioworks aims to develop an in vivo alternative to in vitro mRNA manufacturing technology.
The in vivo mRNA manufacturing method Sensible and Ginkgo are jointly developing is designed to scale to produce 100,000 L of product. The partnership has an overarching aim to manufacture better quality mRNA over traditional IVT.
According to Sensible Biotechnologies, an early-stage biotechnology company based in Europe, and Ginkgo, which is building a platform for cell programming and biosecurity, the mRNA used in vaccines and therapeutics is typically manufactured by in vitro transcription (IVT), which is a cell-free process delivered by purified enzymes.
This type of mRNA production is said to run in a limited reaction volume size, meaning that an expensive purification process is required to remove harmful by-products from the mRNA, which can result in adverse immune responses. Furthermore, both parties said it is challenging to manufacture high yields of specific kinds of mRNA in an IVT reaction.
“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.”
Additionally, the partnership builds on Ginkgo’s mRNA-related pipeline programs.
Ginkgo’s mRNA activity
Ginkgo supported Moderna through optimizing processes for raw materials used to make mRNA vaccines during the COVID-19 pandemic. The firm also partnered with Aldevron in August 2021 and said the collaboration had resulted in a breakthrough for Vaccinia Capping Enzymes (VCEs) with a tenfold mRNA improvement. In October 2022, Ginkgo acquired Circularis, a circular RNA biotechnology firm to support growing demand for nucleic acid and advanced therapy services.
“As the market for mRNA continues to expand, biopharma companies are looking for more efficient and scalable production platforms to produce high-quality mRNA,” said Austin Che, head of strategy at Ginkgo.
“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.”