Analytical Formulation Stability

Analytical Development

AGC Biologics develops analytical methods for product release, product characterization and process development support. Robust and validated release methods, including bioassays, are developed to ensure the identity, safety, purity and potency of your product.

Our in-house bioassay group specializes in development and validation of cell-based assays. This speeds results and eliminates the need for third party interactions.

PRODUCT CHARACTERIZATION

Lab_Analy_HPLC_032_crop.jpgOur broad analytical characterization capabilities allow us to characterize carbohydrates, verify primary structure, identify post-translational modifications and more. Our methods are applied to final product characterization, reference material qualification and comparability studies.

We routinely coordinate our protein characterization activities with Process Development to monitor your protein quality attributes throughout the development process.

For example, we can monitor protein folding, optimize clone selection and bioreactor conditions for desired glycosylation patterns and monitor impurities, such as under-sialylated species or oxidation variants, during development of the purification process. This saves valuable process development time, keeping the process focused on producing the protein with the desired product quality attributes.

With our talented staff, fully equipped labs and extensive experience with molecules from antibodies to complex glycoproteins, AGC Biologics is your number one resource for analytical protein characterization, all under one roof.

 

KEY ANALYTICAL development CAPABILITIES

  • Potency assays
  • Carbohydrate analysis (quantitative sialic acid and monosaccharide analysis, N-glycan profiling)
  • Protein intact mass profiling by LC-TOF MS Peptide mapping by LC-MS/MS
  • SEC-MALLS for aggregate characterization
  • CD, fluorescence and FTIR for secondary/tertiary structure characterization
  • HPLC and electrophoresis

While our analytical development services are part of a comprehensive development and manufacturing program, they can also be offered as standalone services. We develop analytical methods for a wide range of proteins, including monoclonal antibodies and Fc fusion proteins, enzymes, growth factors, complex glycoproteins and novel recombinant constructs.