Eramol Sevenoaks Sterile Facility
Advanced Aseptic and Terminal Sterilisation with End-to-End Services
Eramol’s Sevenoaks sterile facility represents the next phase of our end-to-end manufacturing capabilities. Acquired in September 2023, with construction initiated in April 2024, the facility is scheduled to be fully operational in Q3/Q4 2026. Purpose-built to meet the needs of early-stage clinical supply, it provides flexible, high-quality sterile manufacturing services for a broad range of modalities, integrated with full downstream support.
Facility Overview
- Total campus size: 11,000 m²
- Sterile facility footprint: 2,000 m²
- Fallow space for stage 2 build: 2,000 m²
- Operations: Multi-shift 24/7
The sterile facility is designed by Qualified Persons (QPs) with quality at the forefront of every decision, optimising processes to minimise drug product losses and ensure compliance with GMP standards.
For programmes requiring small-batch injectable manufacture, explore Eramol’s early-phase sterile fill-finish services.
Core Capabilities
The initial build focuses on vial fill-finish for phase I and II clinical trials, including:
- SMALL MOLECULES
- LARGE MOLECULES/BIOLOGICS
- ATMPS/CELL & GENE THERAPIES
- ADCS, RNA THERAPEUTICS
- OLIGONUCLEOTIDES
- PEPTIDES
- MONOCLONAL ANTIBODIES (MABS)
- VIRAL VECTORS
- RADIOPHARMACEUTICAL COLD KITS
- SOME CYTOTOXICS
Integrated End-to-End Services
Alongside sterile manufacturing, the facility will provide:
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- Packaging & labelling for clinical supply
- Quality Control (QC) testing
- Qualified Person (QP) release for EU and UK markets
- Storage under GMP/GDP conditions
- Global distribution with secure, traceable logistics
This ensures seamless management of the product lifecycle, from sterile manufacture through release and delivery to clinical sites worldwide.
Stage 2 Build: Planned Expansion for Phase III and Commercial Supply
Planned for 2027/2028, Stage 2 will expand sterile manufacturing capacity to support larger batch sizes, automated vial, cartridge and pre-filled syringe filling, and future late-stage clinical and commercial programmes.
- Phase III clinical and commercial manufacturing
- Additional dosage forms: cartridges, syringes, and pre-filled pens
- Increased cleanroom capacity leveraging 2,000 m² of fallow space
This phased development ensures scalable operations while maintaining the highest quality standards.
End-to-End Integration
The sterile facility is fully integrated with Eramol’s Sevenoaks non-sterile campus, QC laboratories, packaging capabilities, and Dublin EU hub, providing:
- Optimised material flow and minimal handovers
- Consistent compliance and quality oversight
- Efficient global supply chain support
Designed for Quality, Flexibility & Clinical Success
Eramol’s Sevenoaks sterile facility is engineered to deliver:
- High-quality early-phase clinical supply
- Multi-modality sterile manufacturing
- Flexible batch sizes and 24/7 operations
- End-to-end services including packaging, labelling, QC, QP release, storage, and distribution
- Scalable infrastructure for late-stage and commercial supply
Eramol – delivering world-class sterile manufacturing with quality and product protection at the heart of every process.
QP led company:
Earlier identification of release risks
Practical batch-record design
Better alignment between manufacturing and certification
Reduced handoff between manufacturing and QP release
UK and EU release strategy considered from project initiation
Faster deviation and documentation resolution
