Avecia expands oligonucleotide capabilities

Avecia is to upgrade its biotechnology facility at Grangemouth in Scotland to an all-phase production facility with the setting up of a dedicated new early phase production unit for oligonucleotides.

The new unit will supply European customers with material for preclinical through to Phase II clinical trials. Integration of the new early phase and existing late phase facilities will save in time and costs associated with technology transfer, and will speed up production time, the company says.

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$1m 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.

Commissioned in 1999, the oligonucleotides facility at Grangemouth remains the largest of its kind outside the US and following this upgrade matches the capabilities of its sister plant at Milford, near Boston in Massachusetts, which has been expanded twice since it was acquired in 2000. Both now offer full pipeline capability, from pre-clinical and early phase through to launched products and have a combined annual capacity in excess of 800kg.

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

According to Dr Kevin Cox, Avecia's vice president for biotechnology, this latest investment signals Avecia's commitment to a growing European customer base. 'This already accounts for more than 20% of the market for pre- and early clinical manufacturing of oligonucleotides,' he pointed out.