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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), who provides expertise in subvisible particle characterization and quantitation by flow imaging using a FlowCAM® instrument. Together, we have performed a large number of studies for a variety of clients.

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.

Having a facility dedicated to this method that can they be deployed as part of ongoing formulation development activities at Legacy is a real advantage for the client. To date, Legacy and Great Lakes have used AF4 for seven different projects. We are discovering the value of using orthogonal methods, both to guide process development as well as designing final dosage forms.

There is a new 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.

GMP Bio LLC (Newbury Park, CA) is the latest addition to our strategic network. As you may guess from the name, GMP Bio conducts analytical testing under cGMP conditions. This includes method development and validation, ICH stability testing, and analyzing samples for lot release, all for early stage biopharmaceutical products. Currently, GMP Bio can conduct HPLC and UPLC testing along with light obscuration (HIAC). Please contact us if you are interested in their services. The GMP Bio web site should be operational in the near future.


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.

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).

Elion Labs (Lafayette, CO USA) conducts a wide range of analytical testing in support of biopharmaceutical product development. Founded by former Amgen analytical scientists, they bring a wealth of experience to analysis of peptides and proteins. You can learn more by visiting their web site, www.elionlabs.com