XenovaBio facilities

Facilities
Xenova's facilities are modern, versatile and efficient. They comprise two independent suites, for protein as well as live virus product manufacture, each with separate aseptic filling suites classified as Class 100 / Grade A / ISO Class 5. Our facilities are GMP compliant, MHRA authorised for the manufacture of IMPs and meet the requirements of the United States FDA and the EU Clinical Trials Directive.

	Key Features.

	Building
	11,000ft² divided into; proteins production, virus production, quality control, stores, engineering, packaging and general support. View floor plan

	Proteins Production
	Our Class 10,000 rooms feature laminar airflow, microbiological safety cabinets to achieve a Class 100 environment for aseptic manipulation.

	Virus Production
	Built and maintaining the same specification as the proteins suite our Virus production suite achieves a Class 100 environment.


	Filling suites
	Our post manufacture filling suites, one for proteins and one for viruses, are capable of loading biologics into vials or ampoules as appropriate, also achieve Class 100 status.

	Regulatory Status
	Our manufacturing facilities were specifically designed for the production of biologicals and are consistently GMP qualified.

	The facilities are MHRA approved Xenova Biomanufacturing being licence holders for the manufacture of IMPs (Investigational Medicinal Products).

	All facilities are in compliance with European Union Clinical Trials Directives and meet the requirements of the United States Food and Drug Administration.

	Our Quality systems, as required by GMP, cover all areas and systems and are implemented by experienced quality professionals.