Avecia Biotechnology Advanced Biologics Centre, Billingham, United Kingdom

Avecia Biotechnology announced on 28 February 2002 a US$100 million (£70 million) investment in a new advanced centre for biologics manufacture in Billingham, UK. Construction of their Advanced Biologics Centre in the northeast of England commenced on 25 March 2002. It has remained on schedule and the first phase is due to be completed and in production in late September 2003.

The plant is to be constructed in two phases and will eventually have 40,000 litres of manufacturing capacity for the production of protein biologics from microbial cell lines. The first phase will include the commission of two 5,000 litres bioreactors with independent separation and purification suites to allow multi-product manufacture.

The second phase will be based around the addition of two 15,000 litres bioreactors and associated independent separation and purification streams. The target date for this additional capacity to be on-line and in full production is 2004/2005. The fully operational facility will be capable of running four large scale manufacturing campaigns at the same time.

CONTRACTORS AND CONSTRUCTION

The contractor responsible for engineering, procurement and project management is WS Atkins Plc, Leeds, UK. The architectural design services are being provided by Clean Design Ltd of Stockton, UK. The two 5,000 litres bioreactors were designed and constructed in Switzerland by BioEngineering AG and were delivered on-site ready for installation on 7 October 2002. The 10km of stainless steel pipework required for the first phase was installed in early June 2003. An integrated qualification team was formed by Avecia and WS Atkins and located on-site in June 2003.

TECHNICAL SPECIFICATION AND FACILITIES

The new plant will contain a 62,000ft² process building, a 15,000ft² GMP warehouse, an additional 8,000ft² for support areas and more than 30,000ft² for the second phase of the project.

The Billingham site already has an existing plant with 100/1,000 litres capacity bioreactors to provide smaller scale quantities of products for use in early stage clinical trials. The new plant facilities will allow transfer of processes to large-scale manufacture and the older plant can assume a process development role. The new facilities will include eight process suites equipped with independent air handling systems and Streamline" technology (Chinook Engineering) for air quality monitoring. The process suites will be equipped with ultra-pure water (USP24), clean steam for CIP and SIP procedures, effluent collection and inactivation facilities and the capability to add methanol, oxygen, ammonia, nitrogen, acid or alkali to ferments as required by process methodology.

The equipment will include two independent streams with 50 litres to 500 litres and 5,000 litres capacity. There will be a 10,000 litres fold/refold system for peptide processing and all the required facilities for downstream processing such as centrifugation, ultra-filtration, homogenisation and chromatography. There are also five new QC laboratories, which have been completed and these are being equipped as of July 2003.

PROGRESS OF VALIDATION

The target date for the plant to enter production in its first phase is September 2003. The commissioning of equipment is proceeding. An Avecia progress report, dated 3 July 2003, stated that nearly all the equipment is now in place. Factory Acceptance Tests (FAT) have been carried out successfully on downstream processing equipment such as centrifuges, bioprocess controllers and ultra-filtration facilities.

Other plant systems currently undergoing commissioning are water purification, pure steam generation, cold rooms, product freezer, chilled water and process and instrument air systems. A Site Acceptance Test (SAT) was successfully carried out and passed in March 2003.

GOVERNMENT GRANTS AND EMPLOYMENT

The Avecia investment in the plant at Billingham has been supported by a government grant of £6.5 million from the Department of Trade and Industry. The plant is expected to bring over 300 science-based jobs to the northeast of England. The plant construction and support services to the plant have also provided employment.

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