Contained Xcelodose® Technology
Faster times to first-in-man
Xcelodose® removes the need for initial formulation development and the associated stability testing enabling PCI to achieve fast times to first-in-man studies on behalf of its clients. The fully programmable system provides exceptional levels of accuracy and precision. Waste of drug substance is minimized and batch records allow traceability of individual capsules that meet GMP requirements.
Contained Xcelodose® technology for potent molecules…
As the biological activity and the specificity of APIs increase dosage strengths are decreasing, leading to APIs becoming more potent in nature. To complement the Xcelodose® technology, additional investment in containment solutions ensures that PCI is able to support customer demand for the early stage development of highly potent molecules.
PCI’s latest investment in Xcelohood™ and Xceloprotect™ technology provides contained Xcelodose® solutions, ensuring safety by preventing operator exposure. The high levels of containment provide Occupational Exposure Limit (OEL) as low as 0.1µg/m3 over an eight hour time weighted average meeting Safebridge 3 and 4 categorization.
Features of Xcelodose® Technology:
Xcelodose® was first introduced at PCI’s Tredegar facility in 2010 with the installation of the Xcelodose® 120S, semi-automated technology requiring manual separation of the capsules before loading into the dial plate. Filling is automatic and acceptable capsules are then manually capped and closed.
PCI’s Tredegar site has further invested in the very latest Xcelodose® 600S micro-dosing system. This new technology has the capability to fill amounts as low as 100 micrograms at speeds of more than 600 capsules an hour, approximately 5 times faster than filling the capsules by 120S. The Xcelodose® 600S is fully automated and is controlled by an programmable logic control (PMC) system.