Process Characterization Services

Wheeler’s team utilizes our extensive late stage development experience to efficiently design and execute smart PC programs that balance timeline needs with your program's risk profile and budget targets. By utilizing Design of Experiments (DoE) models as well as robust Process Data Analytics Software, we are able to deliver the requisite protocols and reports under compressed timelines. We also utilize high-throughput technologies including Ambr® systems and Tecan robotic workstations – together with rapid analytics – to speed the generation of the PC data needed to define a process control strategy. Ultimately, these studies will provide a proven control strategy that will ensure a successful process validation campaign and reliable future commercial supply. Wheeler designs and executes process characterization as an extension of our clinical development services, and we are flexible in which of the following studies we execute to support your overall program needs: • Scale down model qualification • Failure Modes and Effects Analysis (FMEA) • Critical Quality Attributes (CGA) identification • Analytical method validation • DoE (Design of Experiment) or OFAT (one factor at a time) unit operation screening • Resin and membrane reuse • Intermediate & media stability studies • Linkage studies to determine overall process robustness With Wheeler’s comprehensive approach to process characterization, you can trust our proven team of experts to seamlessly take your program to the finish line and complete your journey to FDA approval and commercialization.