Analytical Method Development
Whether you have an analytical method that needs improvement or need one developed from scratch, LSNE can efficiently manage your analytical development needs and expedite your timelines. Our goal is to establish methods that provide you with consistent and reliable results as your compound progresses through the clinic. Once the analytical method has been optimized, we will deliver cGMP compliant documentation to support your regulatory filing needs.
Streamlined Testing at Every Phase
We support early phase development as part of your IND or optimize methods developed by your API or BDS vendor. We can enhance assays to their required phase appropriate level to include additional potency, purity or excipient analysis.
- Drug substance/API identification & release testing
- Drug product in-process, release, and stability
- Raw materials – excipients and intermediates
- Reference standard qualification
- Cleaning method development and verification/validation
- Forced degradation studies
- Impurity profiling
- Material compatibility
- Spike and recovery Studies
Analytical Method Qualification and Validation
Existing methods transferred in and methods we develop in-house are validated according to phase appropriate approaches for cGMP use, and support in-process, release and/or stability testing.