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)