Opening of Analytical Center of Excellence

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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:

Purpose Methods
Physicochemical Characterization and Identity Confirmation/Comparability
  • HPLC
  • Isoelectric focusing (cIEF)
  • SDS-PAGE, CE-SDS
  • UV-Vis spectroscopy
  • Peptide mapping
  • Amino acid analysis
  • Glycan profiling
Purity/Impurities (Charged Isoforms, Fragmentation, Oxidation, Deamidation, Aggregation)/Residual Testing
  • UV-Vis spectroscopy
  • SDS-PAGE, CE-SDS with PA800Plus, reduced and non-reduced 
  • cIEF
  • RP-HPLC, IEX-HPLC, SEC-HPLC
Concentration/Strength/Recovery/Solubility
  • UV-Vis spectroscopy
  • Total protein assays
  • HPLC
Potency/Relative Binding
  • ELISA
Drug Product Properties (Liquid and Lyophilized forms)
  • Container closure integrity test
  • Appearance
  • Weight variation, content uniformity
  • Reconstitution time (for lyophilized drug product)
  • pH
  • Moisture content
  • Osmolality
Safety
  • Endotoxin content

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].