Opening of Analytical Center of Excellence
The Biologics group is pleased to announce the planned opening of an Analytical Center of Excellence in Shrewsbury, MA. This location will facilitate the continued expansion of our analytical and protein characterization services, which reflects the growing needs of the pharma and biotech community in and around the greater Boston area. The center will leverage the current analytical capabilities already in place in Shrewsbury along with capabilities offered in Malvern, PA and Woburn, MA. Combining the services offered by these three locations under one roof allows for faster method development, increased offerings, and stronger collaborations with our clients.
The Shrewsbury Analytical Center of Excellence will offer methods for release testing, short and long term stability, and the comparability testing of biologics. These methods include:
|Physicochemical Characterization and Identity Confirmation/Comparability||
|Purity/Impurities (Charged Isoforms, Fragmentation, Oxidation, Deamidation, Aggregation)/Residual Testing||
|Drug Product Properties (Liquid and Lyophilized forms)||
Currently, we are in the process of finalizing GMP systems and transferring, developing, and qualifying test methods. The facility can currently accept samples for many of these tests for R&D analysis and is expected to start receiving GMP samples for testing in Q4 of 2017. If you are interested in learning more about the facility or to inquire on placing your testing programs in Shrewsbury please contact us at [email protected].