Patheon offers the full breadth of advanced technologies for the analytical method development and validation in support of drug product development leading to NDA and ANDA submissions. Our analytical services include:
- Method Validation in accordance with ICH Q2 and USP requirements
- Protocol driven stability studies
By having analytical method development and validation seamlessly integrated into a complete development program driven by an experienced dedicated team, Patheon is the most rapid and cost-effective way to go from molecule to market.
Method Development and Validation Studies
- Cleaning residual assays
- Stability indicating assays by UPLC, HPLC, and GC (including forced degradation studies)
- Related substances, chiral purity, residual solvents determinations
- Dissolution testing
- Preservative assays
- Physical methods (laser diffraction, Karl Fisher)
- Nasal spray characterization (droplet size, spray pattern, spray content uniformity)
Case Study: Method Development and Validation That Keeps Projects On Track
The Challenge A customer came to Patheon needing clinical trial materials for their peptide product. When transferred to Patheon the validation of the HPLC methods was insufficient and poorly reproducible. This issue had the potential to delay the clinical trials and adversely affect the project’s overall timeline.
The Solution Patheon's experienced team identified and modified the critical parameters, then produced robust, fully validated HPLC analytical methods.
The Outcome The customer received the clinical trial material, and was able to keep their project moving forward on schedule.