Analytical Capabilities
Legacy offers a comprehensive suite of services to facilitate the development of a diverse array of analytical methods, a cornerstone for informed formulation decisions. Our steadfast commitment to rigorous analytical methodology has resulted in our successful contributions to the development of a broad spectrum of techniques, including but not limited to:
High-Performance Liquid Chromatography (HPLC) and Ultra High-Performance Liquid Chromatography (UHPLC)Methods:
Size Exclusion Chromatography
Reversed Phase Chromatography
Hydrophobic Interaction Chromatography
Ion Exchange Chromatography
Spectroscopic Methods:
Circular Dichroism
Infrared Spectroscopy
Fluorescence Spectroscopy
UV-visible absorbance spectroscopy including second derivative spectroscopy
Capillary Electrophoresis:
Capillary Zone Electrophoresis (CZE)
Capillary Isoelectric Focusing (cIEF)
Capillary Electrophoresis with Sodium Dodecyl Sulfate (CE-SDS)
Calorimetric Methods:
Isothermal Titration Calorimetry (ITC)
Differential Scanning Calorimetry (DSC)
For characterization of biomolecules in the dried state, Legacy employs moisture determination, solid-state characterization through Differential Scanning Calorimetry (DSC), and crystallinity assessment via X-ray powder diffraction.
Furthermore, our strategic partnership with Great Lake Bio Design (GLB) enhances our analytical capabilities by providing access to advanced technologies, including dynamic flow imaging microscopy, employing a state-of-the-art FlowCAM® instrument to characterize subvisible particles (SVPs), which has been integral in supporting formulation development efforts.
GLB also provides analytical capabilities that include Asymmetrical Flow Field-Flow Fractionation (AF4). Employing Wyatt Instruments’ DualTec and Helios equipment, we have the capability to craft customized AF4 methodologies tailored to your protein or peptide. The AF4-MALLS methodology allows us to employ an orthogonal method to Size Exclusion Chromatography (SEC). Moreover, it allows for an evaluation of a much wide mass range of aggregates than can be quantified using SEC. This technique has proven invaluable in characterizing large proteins, gene therapy products, and peptides, underscoring its versatility and importance.