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The Legacy BioDesign Network

Legacy BioDesign Network

Legacy has partnered with a variety of laboratories and companies to offer specialized services, especially in terms of analytical methods. Therefore, Legacy is a place where one can contract analytical testing services as well as formulation development. These can be used to support comparability testing, lead candidate selection, stability studies, or biophysical characterization. These studies can be done in a seamless fashion for the client, but offer world-class expertise and experience for techniques that require specialized skills.
We have the following members within our distributed analytical network. These organizations serve Legacy exclusively, thereby making them an extension of Legacy BioDesign.

West Coast BioDesign (Goleta, CA),For many years, West Coast BioDesign (WCB) has been our partner laboratory, focusing on characterization of subvisible particles. With the retirement of Glenn Wilson at the end of 2022, the flow imaging capabilities of WCB have been moved to Great lakes Bio Design (GLB), as described below. The HIAC capabilities have been shifted to HTL Biosolutions (see below).

Great Lakes Bio Design (Charlotte, MI) launched in January of 2014 and focuses on AF4 (asymmetrical flow field-low fractionation) as an alternative to SEC for aggregate quantitation and characterization. Along with AUC, AF4 is widely recognized by regulatory agencies as an accepted orthogonal method to SEC.  Great Lakes can also perform SEC-MALLS analyses as well for biologics.

With the closing WCB, GLB has purchased a new FlowCAM flow imaging microscopy system and is now performed subvisible particle characterization for various Legacy projects.
There is a review article published by Legacy, Great Lakes and West Coast on the use of orthogonal methods to SEC (especially AF4 and AUC). It is entitled “Review of Orthogonal Methods to SEC for Quantitation and Characterization of Protein Aggregates”. It appeared in the December 2014 issue of BioPharm International.

In addition, Legacy BioDesign has established strong partnerships with:

HTL Biosolutions (Camarillo, CA), which extends our capacity for formulation development and stability testing. HTL and Legacy have worked together on both peptide and protein formulation projects.

SGS Quay Pharma (Deeside, UK) For projects involving solid dosage forms, especially for peroral delivery, Legacy can work with Quay Pharma in the UK to develop the final dosage form for preclinical and clinical testing.
Legacy also uses a number of university core facilities and laboratories, including the University of Kansas (mass spectrometry), Caltech (NMR), University of Colorado (mass spectromentry, amino acid analysis), and Colorado State University (mass spectrometry, calorimetry).