Method validation

Our extensive knowledge and experience in analytical method validation (AMV) for APIs, finished products, cleaning, bioanalytical and microbial testing ensure your product and processes are of high-quality, are safe and meet regulatory standards.

Our analytical method validation processes include:

• Protocol and report design: Designing validation protocols and reports that outline the procedures, acceptance criteria and approaches for the method validation studies
  
• Execution of validation studies: Perform validation studies according to the designed protocols, utilizing state-of-the-art instrumentation and facilities
  
• Documentation and reporting: Comprehensive documentation of validation activities, including analytical protocols, raw data, analytical reports and validation summaries adhering to regulatory guidelines for proprietary and non-proprietary test methods
• Regulatory guidelines compliance: All methods conducted in compliance with the Notes for Guidance Validation of Analytical Procedures, Definitions and Terminology and Validation of Analytical Procedures Methodology by the ICH (Q2, R2) and FDA, EMA guidelines
  

Our method development and validation services include:

• Quantification: Protein concentration by OD280 and SoloVPE
• Purity: Size exclusion (SE) and cation-exchange (CE) HPLC, reduced and non-reduced CE-SDS, RP-HPLC
• Potency: Potency by in vitro bioassay
• Safety: Bacterial endotoxin, bioburden, sterility, host cell protein (HCP), host cell DNA (HCDNA), residual protein A
• Assay: RP-HPLC, content, water determination