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)