MHRA Authorisation For Flagship Avecia Biotechnology Inc. Facility
BILLINGHAM, England, November 28 /PRNewswire/ -- Avecia's Advanced Biologics Centre at Billingham, UK has received continued Manufacturing Authorisation following an inspection by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
The Authorisation (September 2005) confirms Avecia's Biologics facilities and cGMP operations to be in general compliance with the principles and guidelines of GMP as laid down in Commission Directive 2003/94/EC. This is the first MHRA inspection for the company's ABC 5000 large scale biologics facility, while also covering Billingham's ABC 1000 development scale plant which was inspected in 2001 and 2003.
In commercial operation since early 2004, Avecia's ABC 5000 facility is named for its twin 5,000-litre microbial fermentation production streams. The development scale ABC 100/1000 plant has been considerably expanded since coming on stream in 1998.
Avecia's Biologics business is a process development and contract manufacturing partner for some of the most innovative companies in biotech healthcare. Protein based biologics are a rapidly growing sector of the market with new drugs targeting serious diseases, such as cancer and heart conditions.
Notes to Editors:
- Avecia Biotechnology is a world leader in development and contract manufacturing services for Biologics and DNA medicines. The company's Billingham, UK site has been making clinical trial quantities of protein-based biologics since 1998. Products currently being worked on include medicines targeted at forms of cancer, heart conditions, stroke, growth and blood disorders. See www.aveciabiotechnology.com
- Avecia is a privately-owned specialty chemical company with leading positions in biopharmaceutical process development and manufacturing and ink jet colour printing technologies. The company had 2004 sales of GBP200m and operates across nine sites in the UK, North America and Japan. See www.avecia.com
- The MHRA is the UK body for the regulation of development, manufacture and sale of medicinal products, with some similar functions to the US Federal Drug Administration (FDA). Certifications of GMPs by the MHRA accords with the latest international guidelines on production of APIs, issued through the joint industry/regulatory body the International Conference on Harmonisation (ICH).Avecia
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