The Legacy BioDesign Network
Legacy has fostered strategic alliances with other laboratories over the years in order to offer a wider spectrum of specialized analytical ervices. These services allow us to undertake comparability testing, lead candidate selection, stability studies, and biophysical characterization. In particular, the following organization is an integral collaborator, functioning as an extension of Legacy BioDesign:
Great Lakes Bio Design (Charlotte, MI): Commencing operations in January of 2014, Great Lakes Bio Design (GLB) specializes in AF4 (asymmetrical flow field-flow fractionation) as an orthogonal method to SEC for aggregate quantitation and characterization. AF4 is able to separate analytes over a very wide range of sizes and molar masses. We have used it to charterize everything from peptides to complex protein assembly states to genetic and cellular therapies. Great Lakes Bio Design is also equipped to perform FlowCAM flow imaging microscopy analyses to characterize subvisible particle populations. Legacy has employed FlowCAM in the majority of its projects for clients.
Legacy and GLB jointly authored a comprehensive review article titled “Review of Orthogonal Methods to SEC for Quantitation and Characterization of Protein Aggregates.” (Manning et al., BioPharm Intl. 2014, 27(11): 32+). In addition, together, we have published on the use of AF4 for peptide analysis (Manning et al., J. Pharm. Sci. 2021, 110: 3979-3972) and the characterization of a self-assembling protein using AF4 (Manning et al., Current Protein and Peptide Science 2022, 23(12): 862-873)
HTL Biosolutions (Camarillo, CA): This collaboration expands our capabilities in formulation development and stability testing. HTL and Legacy have collaboratively undertaken projects centered on both peptide and protein formulations.