ASSAY DEVELOPMENT

Legacy can assist in developing a variety of analytical methods. We believe one must have solid analytical methods in place to make the best formulation decisions. Over the years, Legacy has helped develop

• HPLC Methods (size exclusion, reversed phase, hydrophobic interaction, ion exchange)
  
  
• Spectroscopic Methods (circular dichroism, infrared, fluorescence)
  
  
• Capillary Electrophoresis (CZE, cIEF, CE-SDS)

In addition, through our partnership with Great Lakes Bio Design (GLB), Legacy has the ability to characterize subvisible particles (SVPs) by flow imaging using a FlowCAM® instrument. We have performed a number of flow imaging studies on a wide variety of projects. Flow imaging can be used to support formulation development activities or we can develop a method and run sample for your particular compound.

In addition, our network has established another analytical capability in AF4 (asymmetrical flow field-low fractionation) at GLB. Using Wyatt Instruments’ DualTec and Helios equipment, Legacy, in conjunction with our partner, Great Lakes BioDesign, can develop an AF4 method that is customized to your protein and then use that method to monitor aggregation during real-time or accelerated storage studies. Very few CROs have this capability and the knowledge base that Legacy has to use it correctly as an orthogonal method to SEC. As the FDA requests methods orthogonal to SEC on an increasing basis, AF4 becomes increasingly important for characterization of therapeutic proteins. It is also a valuable technique to characterize large proteins, gene therapy products, and peptides.