Analytical Method Development 2019-07-25T19:24:29+00:00
Home > Services >

Analytical Method Development

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