Senin, 22 Februari 2010

Avecia Expands DNA Capabilities to Serve Growing European Market

Avecia Expands DNA Capabilities to Serve Growing European Market



Avecia has announced a dedicated new early phase production unit for DNA medicines (oligonucleotides) at its Grangemouth, Scotland Biotechnology facility. The new unit will supply European customers with material for pre-clinical through to Phase II clinical trials.



(PRWEB) February 13, 2004



Avecia has announced a dedicated new early phase production unit for DNA medicines (oligonucleotides) at its Grangemouth, Scotland Biotechnology facility. The new unit will supply European customers with material for pre-clinical through to Phase II clinical trials.



The addition upgrades Grangemouth to an all-phase production facility. Integration of the new early phase and existing late phase facilities will save in time and costs associated with technology transfer - and speed production time.



Avecia Biotechnology has already installed the first stage of the new early phase facility and is operating at batch scales up to 40g. The full US $1,000,000 equipment package will be in place this Spring, geared to the production of 2 - 100g batches. Avecia is already the world's largest producer of DNA medicines.



The investment is Avecia's second advance in recent months to specifically benefit European customers developing oligonucleotides medicines. In Autumn 2003 Avecia gained certification of its DNA Medicines and Peptides facilities by the UK Medicines and Healthcare Regulatory Authority (MHRA). Accordingly, Grangemouth now has crucial EU-wide recognition as a licenced facility in line with the forthcoming European Clinical Trials Directive.



Introduction of early phase capabilities at Grangemouth means that Europe-based customers will have an intra-EU licenced manufacturing source, eliminating the costs of import tariffs and mandatory testing - and avoiding the complications of technology transfer.



"When evaluating a potential opportunity in DNA medicines, investors are increasingly interested in the robustness of the manufacturing supply chain. The continuity brought by this new investment will reduce the risk of time delays", commented Dr Kevin Cox, Avecia's vice president for Biotechnology. "It also signals our commitment to a growing European customer base. This already accounts for over 20% of the market for pre - and early clinical manufacturing of oligonucleotides".



The development gives Grangemouth matching capability to Avecia's DNA medicines facility in Milford, near Boston MA, USA. Both now offer full pipeline capability, from pre-clinical and early phase through to launched products.



Commissioned in 1999, the oligonucleotides facility at Grangemouth remains the largest of its kind outside the USA. The sister US plant at Milford has been expanded twice since acquisition in 2000.



Innovation by Avecia in developing large scale manufacturing processes for DNA medicines was recognized during 2003 by The Queen's Award for Enterprise, presented at Grangemouth.



For more information contact:



Avecia Public Affairs Group



Tel +44 (0)161 721 2942 / 2441



Fax: +44 (0)161 721 5319



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