Analytical Methods

Mark Staples has developed a wide range of methods for drug analysis (physical and chemical characterization and impurity quantitation) and the transfer of analytical methods to GLP and GMP environments.

Method development assistance is available for most techniques used to characterize and release drug substance and product-

1. •Spectroscopy: UV, Visible, FTIR, fluorescence, CD, NMR, MS, XRD, ICP, MALLS, light obscuration (HIAC)
   

2. •Thermal analysis: TGA, DSC/MTDSC
   

3. •Chromatography (HPLC) assay methods: HPLC (bases of separation: RP, normal phase, ion exchange, hydrophobic interaction, affinity, SEC)
   

4. •Electrophoretic methods (proteins): SDS-PAGE, CE, IEF, Western blots
   

5. •ELISA-based assay methods: Microtiter plate-based assays (UV/visible detection)
   

Support is also available for tasks associated with method development-

1. •Method transfer to GLP and GMP laboratories: Drafting and reviewing protocols, work plans, reports for method transfer
   

2. •Stability: Drafting and reviewing protocols, work plans, reports for stability studies