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 North America (Xcelience – Tampa, FL) and Europe (Ploermel, FR). Both sites have 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.
Select the Micro-dosing System that meets your needs