method development and validation case study

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.

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