Methods Development & Validation
EXPERTLY MEETING THE SPECIFICITY DEMANDS OF ANALYTICAL ASSAYS
Catalent utilizes a step-wise approach for analytical testing. The activities completed are appropriate to the phase of the drug development. Analytical activities will be completed with reference to International Conference on Harmonization (ICH) requirements, or any globally relevant regulatory guidance, whenever appropriate.
Our focused studies provide a range of benefits that can enhance your final outcome:
- Extensive experience in method development, optimization, qualification and validation
- Custom designed for your drug substance and/or drug product
- Catalent will demonstrate that system suitability requirements are met using standards and/or 1–2 samples (when available).
- Catalent will perform sufficient evaluation to establish confidence that required method parameters can be met.
- It is assumed that these methods are robust and will require minimal effort to establish at Catalent (no development or adjusting of method parameters).
- Compendial methods must be taken from a recognized compendium such as the USP/NF, Ph. Eur., and JP. Catalent assumes the methods do not require validation as they will be run as per the compendia.
- Catalent requires documentation of validation for the method/s to be transferred.
- Catalent will provide a transfer protocol (in standard format) for Client approval prior to initiating the transfer study. Results generated by Catalent will be compared with those of the transferring facility.
- Catalent will demonstrate that the method is operational by generating data (e.g., spectra, chromatograms, etc.) using standards and/or 1–2 samples, and demonstrating that system suitability requirements are met.
- It is assumed that these methods are robust and will require minimal effort to establish at Catalent (no development or adjustments of method parameters)
- Evaluate methodology based on the development phase
- Optimize the reagent selection, the sample introduction, and the sample size
- Approximate, instantaneous solubility study to assess possible diluents and mobile phases
- UV spectrum of the API to assess detection wavelength
- Informal forced degradation study to select one marker solution for method development (thermal and photolytic stress conditions)
- Scouting run to determine column chemistries
- Sensitivity evaluation
- Pre-Validation Exercise – mini linearity, LOD/LOQ, specificity check before committing to formal validation
- Assess stability in preferred media in 37 C for duration of dissolution tests
- Optimize medium, paddle/basket speed and sampling times for final formulation for dissolution tests
- Accuracy, Linearity, Repeatability, Intermediate precision and System precision
- Specificity – including limited forced degradation studies for stability indication chromatography methods at early phases and full forced degradation studies at late phases (acidic, basic, oxidative, thermal and photolytic stress conditions)
- Limits of detection and quantitation
- Solution stability
- Peak Purity by Photodiode Array (PDA) for stability indication chromatography methods
- Robustness assessments (assessed by making small deliberate variations in method parameters and measuring the effect)
- Additional critical aspects of the assay will be included (as necessary)