Process Characterization Services
Wheeler Bio is laser focused on supporting the translational space from discovery to early clinical trials, underpinned by a deep understanding of what it takes to take a program through commercial approval. As a critical step in the path to commercialization, process characterization of the manufacturing process for drug substance supply is an essential milestone.
Wheeler’s robust process characterization strategy has been developed by our process development experts who have extensive experience in designing and executing exemplary PC studies for BLA submission for FDA approval. Our process characterization team will ensure that your drug’s manufacturing process results in the highest quality product possible and meets all safety and consistency standards required to progress to commercial manufacturing.
Learn more about Wheeler Bio’s cutting-edge process characterization capabilities.
Process Characterization at Wheeler Bio
With decades of late-stage experience, our process engineers and scientists are well-versed in all aspects of process characterization and in meeting the FDA’s process validation standards. By meticulously analyzing key and critical variables involved in upstream and downstream manufacturing processes, our team can optimize your manufacturing process from start to finish. This ensures a robust process and analytical panel that will comply with FDA BLA filing requirements and provide a reliable supply of product, while avoiding any potential delays to commercial registration and preventing manufacturing failures during commercial supply campaigns.
Smarter Characterization Programs
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.
Process Characterization Studies
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.