New technology decreases processing time and API use - generating significant cost savings

Almac, an integrated contract development and manufacturing organisation supporting the international pharmaceutical and biotechnology industries, has further enhanced its offering by adding 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 Xcelodose^® system can significantly reduce processing time and API usage resulting in cost savings when compared to hand filling options

“Almac is continually assessing and investing in solutions to accelerate the manufacturing of our client’s clinical supplies, while ensuring quality at all times,” said John McQuaid, Technical Development Manager.

McQuaid added: “Whilst Almac has always offered API in capsule shells, we now see examples of some clients maintaining this approach through to Phase II studies in an attempt to compress their overall development timelines, requiring significant quantities of capsules for which an automated solution is best.”

Complementing Almac’s existing containment capabilities for processing compounds with an OEL ranging from 0.03 – 10μg / m3 / 8hrs TWA, the Xcelodose^® 600S system will include an Xcelohood™ system to offer containment when filling capsules with API of high or unknown toxicity.

David Edwards, Capsugel’s Director of Pharmaceutical Technology commented: “We are delighted to be working with Almac in this area. We see this as yet another recognition by pharmaceutical companies that the use of the Xcelodose^® system and ‘API in a capsule’ dosage forms are valuable tools for speeding up the process of early stage pharmaceutical development in both Phase I and Phase II studies.”

The Xcelodose^® system, manufactured by Capsugel, is a precision powder micro-doser and automated encapsulator that has the ability to fill formulations or API directly into capsules with a high level of accuracy. The Xcelodose^® system can dispense amounts as low as 100 micrograms and up to 100 milligrams 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.

Almac will install the Xcelodose^® system in its state-of-the-art product development facility in Craigavon, UK. The unit will be installed and validated, ready for use from March 2010.