New England Biolabs (NEB®) announces the release of the Faustovirus Capping Enzyme (FCE), an mRNA capping solution that combines high activity and a broad temperature range to support mRNA therapeutic manufacturing needs.

As a single-subunit enzyme, FCE contains all the enzymatic activities to achieve a Cap-0 structure, a critical step in eukaryotic mRNA maturation. When used in conjunction with NEB's mRNA Cap 2´-O-Methyltransferase, users can generate a Cap-1 structure in a one-pot reaction.

"The biological versatility of mRNA continues to propel its rise as a therapeutic modality within infectious disease, oncology and beyond," said Breton Hornblower, Product Portfolio Manager at NEB. "We are very excited to introduce FCE – an enzyme discovered at NEB – to our portfolio of products for mRNA synthesis. This new product offers a streamlined, scalable, and cost-effective solution for mRNA capping for both research and therapeutic applications."

"For large-scale mRNA production, I have always favored post-transcriptional enzymatic capping due to the significant advantages in terms of yield. This new enzyme with improved activity at lower temperatures promises great utility for the production of our large (9-16 kb) self-replicating RNA vector," said Andrew Geall, Chief Development Officer at Replicate Bioscience.

When compared to traditional enzymatic capping approaches (e.g., Vaccinia Capping Enzyme (VCE)), FCE is active over a broader temperature range (20°C – 55°C) and demonstrates increased capping efficiency across a variety of mRNA 5´ structures. Additionally, FCE requires less enzyme to achieve the same standards of robust capping.

FCE is manufactured with consideration for the scalability and quality needs of therapeutic manufacturing, and a GMP-grade* format will be available in early 2023. Additionally, FCE is manufactured using environmentally friendly biological processes, avoiding the large-scale use of organic solvents and without producing significant volumes of hazardous waste. The use of FCE does not require any licensing fees from NEB for commercial applications.