Almac adds Xcelodose 600S micro-dosing system to capabilities
Almac, an integrated contract development and manufacturing organisation with businesses in the US and UK, has added an Xcelodose 600S precision powder micro-dosing system to its product development capabilities in response to client requirements for preclinical and early phase clinical GMP supply.
Almac, an integrated contract development and manufacturing organisation with businesses in the US and UK, has added an Xcelodose 600S precision powder micro-dosing system to its product development capabilities in response to client requirements for preclinical and early phase clinical GMP supply.
For simple formulations of API or powder-in-capsule, the company says the Xcelodose system, manufactured by Capsugel, can significantly reduce processing time and API usage and reduce costs when compared with hand filling options. It will be operational at the company's product development facility in Craigavon, UK next month.
"While Almac has always offered API in capsule shells, we now see examples of some clients maintaining this approach through to phase 2 studies in an attempt to compress their overall development timelines, requiring significant quantities of capsules for which an automated solution is best," said John McQuaid, technical development manager at Almac.
Complementing Almac's existing containment capabilities for processing compounds with an OEL ranging from 0.03-10μg/m3/8hrs TWA, the Xcelodose system will include an Xcelohood to offer containment when filling capsules with API of high or unknown toxicity.
The Xcelodose 600S is a precision powder micro-doser and automated encapsulator that has the ability to fill formulations or APIs directly into capsules with a high level of accuracy. It can dispense amounts from 100μg to 100mg and beyond, into capsules from size 00 to 4. Dosing directly into capsules can reduce the amount of API required. Additionally, the unit minimises overall development time by simplifying analytical and stability protocols.
