Biologics / Large Molecule Analytical Services
Catalent Biologics has extensive experience with method development, optimization, transfer, and phase-specific method validations and verifications. Methods include Physico-chemical assays, Functional/Potency assays, Binding assays, Molecular Biological assays, and Microbiological assays.
METHOD DEVELOPMENT / OPTIMIZATION
- We can develop methods at any stage of the product development process. With up-to-date knowledge of regulatory requirements and technologies, our scientific staff can provide our clients with well-developed strategies to guide, customize, and execute the method development plan in an efficient manner to meet clients’ requirements and timelines.
- We can provide method optimization whether it is to complete development of a method that has not been fully optimized, or to optimize methods in response to manufacturing changes, formulation changes, and method robustness issues.
During method development and optimization, progress/status updates are provided on regular basis.
- Catalent Biologics routinely transfers testing activities to or from other laboratories. We provide method transfer services to support characterization methods as well as GMP clinical/commercial release and stability testing.
- Method transfers for GMP clinical/commercial release and stability testing are performed under protocols with both client and Catalent approvals. Regular updates are provided regarding the transfer activity progress,
METHODS LIFECYCLE MANAGEMENT
- Catalent can provide continuous method evaluation throughout product lifecycle (development phases to post commercial). This may include offering advanced and/or alternative techniques to improve the existing method or providing orthogonal methods to support analysis.