Micro-dosing is the process of dispensing a precise amount of drug substance into a capsule (or other container, e.g. vial or bottle), for use in early phase human studies (phase I safety evaluations).
Drug substance “powder-in-capsule” (PIC) studies generally avoid the use of excipients – and the compatibility and stability studies associated with their use – for these initial evaluations thereby accelerating early phase product development timelines. Accelerating these initial studies to determine if the drug substance should receive further investment is critical in cost-effective product development.
A summary of PIC program benefits using Xcelodose® Micro-dosing Systems follows:
Centers of Excellence
Lonza offers PIC services using Xcelodose® Systems in support of early phase clinical programs around the world. Our Center-of-Excellence for PIC studies is based in Tampa, FL which includes micro-dosing, primary and secondary packaging, kitting, global distribution and return services. The Tampa site offers integrated product development and manufacturing, and multiple Xcelodose® units to support both pre-clinical assessments and clinical PIC manufacture.
A full range of preformulation, analytical and formulation development services support phase I-IV studies and commercialization. Best practices have been developed for process transfers from Xcelodose® systems to larger-scale clinical and/or commercial scale batches utilizing Harro Modu-C units.
We offer a range of Micro-dosing Systems to meet your needs: