Analytical Development

We have comprehensive analytical services for cell and gene therapies and protein biologics for every product stage. 

Analytical Development Services

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

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

Product Characterization

Our 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, cell therapy, and viral vector characterization activities with Process Development to monitor quality attributes throughout the development process.

With our talented staff, fully equipped labs, and extensive experience with molecules from antibodies to complex glycoproteins, to cell therapy and viral vector products, AGC Biologics is your number one resource for analytical characterization. 

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

  • Cellular-Based Assays and Stability Activities

  • 160+ Custom In-House Analytical Tests for Clinical and Commercial Supply for Cell Therapy and Viral Vector products

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 protein biologics, cell therapy, and viral vector needs. 

Interested in learning more?

Contact our team