New England Biolabs® Introduces Faustovirus Capping Enzyme, a Novel Enzymatic mRNA Capping Solution for mRNA Manufacturing

New enzyme improves capping efficiency and scalability for mRNA manufacturing workflows, including vaccine generation

IPSWICH, Mass., Aug. 9, 2022 /PRNewswire/ -- Today, 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.

For more details about NEB's new Faustovirus Capping Enzyme, visit www.neb.com/M2081.

Established in the mid 1970's, New England Biolabs, Inc. (NEB) is the industry leader in the discovery and production of enzymes for molecular biology applications and now offers the largest selection of recombinant and native enzymes for genomic research. NEB continues to expand its product offerings into areas related to PCR, gene expression, sample preparation for next generation sequencing, synthetic biology, glycobiology, epigenetics and RNA analysis. Additionally, NEB is focused on enabling new technologies in key market sectors, including molecular diagnostics, clinical sequencing, and nucleic acid-based therapeutics and vaccines. New England Biolabs is a privately held company, headquartered in Ipswich, MA, and has extensive worldwide distribution through a network of exclusive distributors, agents and eight subsidiaries located in Australia, Canada, China, France, Germany, Japan, Singapore and the UK. For more information about New England Biolabs, visit www.neb.com.

*"GMP-grade" is a branding term NEB uses to describe reagents manufactured at NEB's Rowley facility. The Rowley facility was designed to manufacture reagents under more rigorous infrastructure and process controls to achieve more stringent product specifications and customer requirements. Reagents manufactured at NEB's Rowley facility are manufactured in compliance with ISO 9001 and ISO 13485 quality management system standards. However, at this time, NEB does not manufacture or sell products known as Active Pharmaceutical Ingredients (APIs), nor does NEB manufacture its products in compliance with all of the Current Good Manufacturing Practice regulations. 

NEB^® and NEW ENGLAND BIOLABS^® are registered trademarks of New England Biolabs, Inc.

SOURCE New England Biolabs