Eramol is progressing the development of its purpose-built sterile fill-finish facility in Sevenoaks, Kent, designed to support Phase I and Phase II injectable clinical-trial programmes with flexible batch sizes, isolator-based aseptic processing with <0.1% line losses and integrated packaging, labelling, QC & UK and EU QP release.
Sevenoaks, UK: Eramol is advancing the development of its new sterile fill-finish facility in Sevenoaks, strengthening UK capacity for early-phase injectable clinical-trial manufacturing.
Scheduled to become fully operational in Q3/Q4 2026, the purpose-built facility is designed for Phase I and Phase II programmes that require flexible small-batch manufacture, strong regulatory oversight and protection of scarce or high-value drug substance.
The facility will provide both aseptic fill-finish and terminal sterilisation, supported by Grade A isolator and UDAF filling environments, closed single-use processing, sterile filtration and moist-heat autoclave capabilities. Eramol’s low-loss filling approach is designed to achieve less than 0.1% line losses, helping sponsors maximise clinical doses from limited early-phase material.
Initial operations will focus on vial fill-finish for Phase I and II clinical trials, with batch sizes of up to 10 litres and capacity for up to 5,000 vials.
Eramol’s sterile manufacturing service will be integrated with clinical packaging, labelling, QC testing, UK and EU QP certification, controlled-temperature storage and global distribution. This will allow sponsors to manage sterile manufacture, regulatory release and clinical-site delivery through one accountable partner.
The Sevenoaks development forms part of Eramol’s wider strategy to provide an integrated UK and EU clinical-supply platform. The sterile facility will operate alongside Eramol’s existing non-sterile manufacturing, packaging and QC infrastructure, with access to the company’s Dublin EU hub for European importation and QP release.
Nathan Gray, Commercial Director at Eramol, said:
“Early-phase injectable programmes need more than filling capacity. Sponsors need a manufacturing partner that understands the value of every millilitre of drug substance, identifies regulatory risks early and can manage the product through manufacture, QP release and delivery to clinical sites.
“Our new sterile facility has been designed around those requirements. The combination of flexible small-batch processing, less than 0.1% line losses and integrated UK and EU clinical-supply services will provide biotechnology and pharmaceutical companies with a highly responsive route into Phase I and Phase II trials.”
A planned second stage of development will expand capacity for Phase III and commercial programmes, including increased automation and additional vial, cartridge, pre-filled syringe and pen-filling capabilities.
To learn more, visit Eramol’s early-phase sterile fill-finish services: https://eramol.com/clinical-services-category/sterile-fill-finish/