TECHNICAL SPECIFICATION

The National Biomanufacturing Centre encompasses biopharmaceutical drug design, development and flexible GMP manufacture for early stage clinical trials.

The facility comprises:

Three GMP suites with capabilities to manufacture biopharmaceuticals from mammalian, microbial and viral sources. The suites will be equipped for the production and purification of biopharmaceutical medicines. The suites are designed to biocontainment (ACDP and ACGM) category 2 and are fully compliant with the latest EU and USA GMP guidelines.

Three process development suites, with dedicated upstream and purification areas and equipment, capable of producing pre-clinical material.

Quality control and analytical development laboratories capable of performing most techniques required for biopharmaceutical batch release and in-process testing.

Office accommodation and secure data archiving facilities.

Ambient, cold and cryostorage facilities.