Eramol’s purpose-built sterile manufacturing facility at the Sevenoaks campus is in the final stages of commissioning and awaiting MHRA inspection. The site is expected to become operational in Q2 2026, subject to regulatory approval.

Commissioning began in mid-January, with the “going clean” phase scheduled for late January/early February. Designed to meet EU GMP Annex 1 (2023) standards, the facility will provide aseptic fill-finish and terminal sterilization services for Phase I and II clinical trial supply.

“This facility represents a significant milestone for Eramol,” said Peter Mollison, Co-CEO and Qualified Person. “From the outset, our priority has been to build a sterile operation that meets the realities of modern Annex 1 expectations while protecting product quality and yield. As we approach MHRA inspection, the facility reflects the standards we expect as QPs and the standards our clients require.”

Eric Che, Co-CEO and Qualified Person, added: “We have taken a deliberately quality-led and phased approach to this build. By embedding regulatory thinking, flexibility, and scalability from day one, we are creating a sterile manufacturing platform that supports early clinical development today and can evolve with our clients into later-stage supply.”

Key features include isolator-based aseptic processing, UDAF booth filling, autoclave sterilization, and batch sizes up to 10 L. The site supports multiple modalities—small molecules, biologics, peptides, oligonucleotides, and radiopharmaceuticals—and is optimized for minimal product loss (<2%).

Integrated with Eramol’s end-to-end supply platform, the facility offers packaging, labelling, QC testing, QP release, and global distribution. A planned Stage 2 expansion will extend capability into Phase III and commercial manufacturing, including additional delivery formats.