Analytical method development and validation services supported by experienced analytical scientists and state-of-the-art equipment are integral to any drug development program. At Lonza, we provide thorough analytical support, candidate screening, drug product analytical services and phase-appropriate method development and validation for drug substances, particle-engineered intermediates, and drug products. Our drug substance analytical services are tailored to your specific program and timelines range from development of early-stage compound handling protocols to optimization of Quality Control methods during late stage development.
Based on the experience of developing thousands of small molecules and a track record in cGMP compliance, we are well positioned to partner with you on all analytical method development aspects of your API.
We understand your analytical objectives throughout the drug development process and work with you to ensure that appropriate methodologies are available at all stages, e.g.
- Early handling protocols for your compound
- Analytical methods to support your early formulation prototype characterization including assay, purity and dissolution
- Phase-appropriate methods to support batch release and stability testing of early phase compound, intermediate or drug product manufacturing
- Method optimization to ensure robustness
- Finalization of analytical methods to support your Phase III, registration and commercial drug substance or drug product manufacturing to cGMP guidelines
- Further analytical method optimization to support cGMP process intensification
End-to-End API Analytical Services
We also provide full analytical method testing from preclinical development through late stage clinical and commercial production of drug product compounds, intermediates and finished drug products, e.g.
- Preclinical prototype evaluations
- Excipient compatibility studies
- Finished product testing including purity, dissolution and physical characterization
- Full range of ICH stability studies (storage and testing)
Our experienced teams of API analysts and our extensive Good Laboratory Practice (GLP)-compliant facilities throughout the globe provide support for development of early formulations, clinical-trial materials, and commercial products. Once validated, analytical methods are routinely used for release of the products in our quality control laboratories.
For optimum responsiveness, we have located state-of-the-art analytical method-development laboratories at each of our integrated product-development sites, providing rapid analytical services to fit your development timelines.