- Eramol is advancing the development of a new Annex 1 GMP sterile fill-finish facility near London to support Phase I to Phase IIb clinical trial supply.
- The facility will support sterile vials, cartridges, and pre-filled syringes across multiple modalities, including biologics, cell and gene therapies, and radiopharma cold kits.
Eramol UK Ltd has announced progress in the development of a new Annex 1 GMP sterile fill-finish facility located just outside London. The company said the facility has been designed to support clinical trial supply for Phase I to Phase IIb programs and will complement its existing non-sterile clinical manufacturing operations, which have been in place since 2021.
The new facility will include both aseptic and terminal sterilization process streams and will initially support batch sizes of up to 10 liters. According to Eramol, the facility is intended to provide manufacturing support for complex early-stage injectable products requiring flexibility and rapid execution.
A central feature of the facility is isolator technology designed to achieve less than 0.1% line losses. Eramol said this capability can help reduce product wastage and improve fill yields, particularly for small-batch or limited-availability drug products.
The facility will support sterile vials, cartridges, and pre-filled syringes. Eramol stated that it will be capable of handling a range of product types, including small molecules, large molecules, biologics, cell and gene therapies, and radiopharma cold kits. In addition to sterile fill-finish manufacturing, the company will offer packaging, labeling, quality control testing, UK and EU Qualified Person release, storage and distribution, and regulatory support services.
Eramol said it expects to expand its capabilities to Phase III and commercial-scale manufacturing capacity in 2027 and 2028, building on its clinical sterile manufacturing platform.
