New Annex 1 Sterile Facility

Eramol Announces Commissioning of New EU GMP Annex 1-Compliant Sterile Manufacturing Facility in Sevenoaks, UK

Purpose-built 11,000 sq. ft. site with 2,000 sq. ft. cleanroom brings modular, high-yield sterile fill-finish to clinical and early-phase commercial programs

Sevenoaks, UK — [January 07, 2026] — Eramol, a specialist sterile manufacturing and fill-finish partner for biopharmaceutical innovators, today announced the commissioning of its new purpose-built sterile manufacturing facility in Sevenoaks, United Kingdom. Commissioning is set to begin in January 2026, with the facility expected to go clean in late January, ahead of qualification and GMP readiness activities.

Designed to support clinical and early-phase commercial drug product needs, the new 11,000 square foot facility, including a 2,000 square foot cleanroom, has been engineered to be fully aligned with the 2023 EU GMP Annex 1 requirements for sterile medicinal products. The facility incorporates a robust contamination control strategy (CCS) and modern sterility assurance approaches, including fully closed processing, single-use technologies, and real-time environmental monitoring.

Eramol’s Sevenoaks site is designed to deliver high-quality sterile fill-finish across a wide range of parenteral modalities, including small molecules, large molecules/biologics, peptides, oligonucleotides, advanced therapy medicinal products (ATMPs) and radiopharmaceutical cold kits. Initial commercial operations will focus on vial filling, supported by equipment capable of expansion to cartridges and pre-filled syringes, enabling future patient-centric delivery formats.

The facility provides both aseptic processing and terminal sterilisation options, offering customers flexibility based on product characteristics and clinical supply strategy. Aseptic fill-finish is available within a Grade A aseptic isolator, as well as within a unidirectional airflow (UDAF) booth, with terminal sterilisation supported by an in-house autoclave with full data traceability.

Eramol’s equipment and process architecture have been designed by Qualified Persons (QPs) with a focus on yield protection and efficiency. By minimising hold-up volume and line losses associated with traditional processing methods, the facility targets line losses of less than 2%, supporting improved yields—particularly for high-value, low-volume therapies.

“This facility is a major milestone for Eramol and a step-change in our ability to support sterile clinical manufacturing,” said Peter Mollison, Chief Executive Officer of Eramol. “We built the Sevenoaks site to be aligned with Annex 1 from day one, with modern sterility assurance approaches including isolator-based filling and closed single-use processing. Importantly, it has been designed by QPs to minimise drug wastage and protect product value, with expected line losses below 2%.”

“Biopharmaceutical pipelines are becoming more diverse and more complex, and the demands on sterile manufacturing continue to evolve,” said Eric Che, Chief Executive Officer of Eramol. “Our Sevenoaks facility gives innovators a flexible, end-to-end sterile manufacturing pathway—from compounding and filtration through fill-finish, QC testing and QP release, to storage and global distribution—supporting seamless scale-up from early development to small-scale commercialisation.”

Eramol’s Sevenoaks facility will offer scalable batch sizes from <500 to 5,000+ vials with high-accuracy fill volumes across 0.5–10 mL, supporting programs from early-phase clinical trials through to small-scale commercial supply. Complementary in-process monitoring and quality controls include container closure integrity testing (CCIT), visual inspection, and sterility assurance, supported by in-house and contract testing services aligned with UKP, EP, USP and ICH expectations.

The site also supports placebo matching and blinded clinical trial readiness, including compatibility with SCHOTT adaptiQ® vial formats to enable high-quality trial blinding.

Key Capabilities at a Glance

• Compounding & Sterile Filtration: Compounding with inline sterile filtration to a sterile single-use closed system, supported by filter integrity testing

• Fill-Finish: Grade A isolator or UDAF filling and crimping, integrated weighing, and real-time environmental monitoring

• Sterilisation: 0.22 µm filtration and/or terminal sterilisation using validated autoclave cycles with full traceability

• Container Closure Integrity: Non-destructive CCIT (vacuum/pressure decay) plus visual inspection

• End-to-End Service: Downstream packaging, labelling, QC testing, QP release, storage and global distribution

About Eramol

Eramol provides a purpose-built, EU GMP Annex 1-compliant sterile manufacturing service designed to support clinical and early-phase commercial parenteral drug products. The Company combines advanced technologies, modular scalability and regulatory-grade quality assurance to deliver agile, high-quality fill-finish solutions across small molecules, biologics, peptides, oligonucleotides, ATMPs and radiopharmaceutical cold kits, with a focus on maximising yields and protecting product value.

Media / Business Development Contact

Nathan Gray
Commercial Director
Eramol
Email: nathan.g@eramol.com