Analytical Biologics

Comprehensive studies for biologics characterization

Analytical Biologics

Due to their size, nature, and biological origin, biologics or biopharmaceuticals are inherently complex in terms of quality attributes. Establishing and monitoring the quality attributes of a biologic is essential to ensure its efficacy and safety. Frontage offers the technical expertise and state-of-the-art instrumentation necessary for biologics characterization and analytical method development/validation. Frontage has supported many biopharmaceuticals including polysaccharides, fusion proteins, monoclonal antibodies, antibody-drug conjugates (ADCs), vaccines, and gene therapy products. 

Comprehensive Analytical Services for Biologics 

  • Release 
  • Stability 
  • Reference standard qualification 
  • In-depth structural elucidation 
  • Comparability or Biosimilarity 
  • Forced degradation 
  • Support for formulation development/process 

Get in touch with our analytical services experts for a quote. 

Analytical Methods for Biologics

  • UV A280 
  • Peptide mapping by CE-MS/MS, LC-MS/MS 
  • Western Blotting 
  • Receptor Binding Potency by ELISA 
  • Intact mass by CE-MS, LC-MS 
  • Free thiol 
  • Thermostability by DSC 
  • Glycan profile by RapiFluor LC-Fluor/MS 
  • Drug antibody ratio by CE-MS/MS, LC-MS/MS 
  • HMW & LMW species by SEC HPLC 
  • Size by CE-SDS 
  • Charged Variant by cIEF, IEX 
  • Product purity by RP-HPLC 
  • Host Cell Proteins by ELISA, CE-MS/MS, LC-MS/MS 
  • Host Cell DNA by qPCR 
  • Process residuals by LC-MS/MS 
  • Endotoxin by LAL 
  • Sub-visible Particles 
  • Cell-based assays 
  • VP Titer 
  • VG Titer 
  • Infectious Titer (TCID50)