Analytical Method Development
LSNE provides full analytical and assay method development services. We have a complete array of analytical equipment and tools to efficiently meet your parenteral development needs.
- Method development
- Method optimization
- Method verification
- Method qualification
- Method validation
With our new, state-of-the-art lab facilities, LSNE has the flexibility and capacity to deliver what you need, when you need it — from method feasibility experiments to full-scale method validation for parenteral development projects.
All test methods, including 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.
It’s part of a comprehensive set of capabilities that allows us to seamlessly handle your entire parenteral development project, from optimizing under-developed assays to product manufacturing to regulatory writing.
New facility offerings
- 4-fold capacity increase
- Expanded chromatography capabilities
- Expanded general chemistry capabilities
- Additional UPLC & HPLC units and detection capabilities
- UPLC, HPLC, GC, Karl Fischer, UV/Vis, SDS-PAGE
- ANDA development support including method transfer/development; validation; in-process, release and ICH stability studies
- QC microbiological support including qualification of bioburden and bacterial endotoxin
- Experience with particle sizing and zeta potential
- FDA inspected