|Articles|August 15, 2022

BP Elements

  • BioPharm International's BP Elements, September 2022
  • Volume 1
  • Issue 9

New England Biolabs Releases Novel Enzymatic mRNA Capping Solution

The Faustovirus Capping Enzyme launched by New England Biolabs is designed to increase capping efficiency and scalability of mRNA manufacturing workflows.

New England Biolabs (NEB), a supplier of enzymes for molecular biology applications, announced the release of the Faustovirus Capping Enzyme (FCE), a messenger RNA (mRNA) capping solution, on Aug. 9, 2022. FCE is designed to improve capping efficiency and scalability for mRNA manufacturing workflows, including vaccine generation.

FCE is a single-subunit enzyme that contains the enzymatic activities to achieve a Cap-0 structure, which is necessary in eukaryotic mRNA maturation. According to a company press release, FCE is active over a broader temperature range (20 °C–55 °C) than traditional enzymatic capping approaches and demonstrates increased capping efficiency across a variety of mRNA 5´ structures.

"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, NEB, in the press release. "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," said Andrew Geall, chief development officer, Replicate Bioscience, in the release. “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.”

According to the release, FCE is manufactured through environmentally friendly manufacturing practices, avoids the use of organic solvents and without producing significant volumes of hazardous waste. A good manufacturing practice-grade format of the enzyme will be available in early 2023.

Source: New England Biolabs


Related to this article

The BioPharm Brief: A Bispecific Approval in Head and Neck Cancer, TCR Bispecifics Head to the Clinic, and a New Antibody Target in Essential Thrombocythemia
FDA grants accelerated approval to Johnson & Johnson’s subcutaneous EGFR/MET bispecific Rybrevant Faspro for previously treated head and neck squamous cell carcinoma, T-Therapeutics raises a $133 million Series B to take TCR-CD3 bispecifics into clinical trials, and Alethio Therapeutics raises a $90 million Series A to advance its first-in-class G6B antibody for essential thrombocythemia.
The BioPharm Brief: Ivonescimab Priority Review in China, Stargardt Gene Therapy Moves Toward Phase 3, and Longer Dosing Intervals for an IBD Bispecific
China’s NMPA grants priority review to Akeso’s PD-1/VEGF bispecific ivonescimab with chemotherapy for first-line biliary tract cancer, VeonGen Therapeutics aligns with FDA on a phase 3 design for its dual-AAV Stargardt gene therapy VG801, and Caldera Therapeutics’ IL-23p19×TL1A bispecific CLD-423 shows a half-life of more than 40 days in a phase 1a trial.