UK-based pharmaceutical contract development and manufacturing organisation (CDMO) Eramol has announced significant progress on its new sterile manufacturing facility in Sevenoaks, Kent, with operations scheduled to commence in early 2026. The 11,000 square foot facility represents a strategic expansion of sterile manufacturing capabilities designed to serve biotech, pharmaceutical, NHS, academic, and virtual pharma companies.
Facility Specifications and Capabilities
The new facility features a dedicated 1,900 square foot GMP Grade A/C cleanroom suite specifically designed for small to medium batch production of sterile injectable products. The site incorporates modern offices and client reception areas, creating a fully integrated, client-ready environment for pharmaceutical manufacturing operations.
Eramol's facility has been purpose-built to meet the stringent requirements of the 2023 EU GMP Annex 1, incorporating industry best practices to proactively identify, control, and mitigate contamination risks. Every aspect of the facility design, from cleanroom layout to environmental monitoring systems, has been engineered to uphold the highest standards of sterility assurance and product quality.
Advanced Manufacturing Technology
The facility will house cutting-edge equipment, including a Fedegari autoclave and high-performance isolator technology, enabling aseptic filling of sterile solutions into 2ml and 10ml vials. The equipment selection prioritizes performance, reliability, and future scalability, ensuring clients can seamlessly transition from early-phase to late-phase or commercial manufacturing.
"This facility reflects our commitment to supporting clients with a flexible, compliant, and forward-thinking approach to sterile manufacturing," said Peter Mollison, Co-CEO and Co-Founder at Eramol. "We've built-in expansion capacity and the agility to scale with our partners to develop long term strategic collaborations."
Implementation Timeline and Services
The isolator installation is scheduled for October 2025, with commissioning and qualification activities, including autoclave cycle development and performance qualification, beginning in September 2025. An MHRA inspection is anticipated by the end of 2025, enabling client onboarding shortly after regulatory approval.
The sterile manufacturing site will provide comprehensive services including aseptic filling and terminal sterilization, small to medium clinical batch production, and end-to-end pharmaceutical services encompassing QP release, storage, and global distribution capabilities.
