Avecia completes expansion of its UK cytotoxics facility
Avecia has expanded its High Potency Substances (HPS) capabilities with completion at Grangemouth, Scotland, of a new US$2m (€1.73m) early phase manufacturing suite. The new multi-product kilo scale suite will supply cytotoxic APIs for Phase I and II clinical trials programmes, together with chemical process development services supporting supply of preclinical r&d materials.
The new 450m2 cGMP compliant manufacturing facility has several notable features. These include classification throughout to Class 100,000, a high integrity isolation unit with integral filtration and combined vacuum, freeze-drying capability, and a Class 10,000 downflow area for low bio-burden processing.
Associated HPS developments at Grangemouth include a small-scale cytotoxic fermentation facility; expanded production capacity for late phase/launched cytotoxic drugs and a new high containment suite for non-GMP development services.
'This is a flexible, multiproduct facility able to service the broadest range of manufacturing technologies, and with particular capability for the new generation of conjugates,' said Avecia Pharmaceuticals' high potency actives business manager Charlie Johnson. 'We can configure the assets quickly to meet customers' need for rapid product supply, supporting their clinical requirements across the widest range of oncology therapies.'
Avecia has been producing anticancer cytotoxics at Grangemouth since 1993. The company has early phase facilities in the UK and Canada consisting of five pilot plants and 12 kilo suites.