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Biologic Analytical Characterization

Life Sciences / CDMO/CRO Services / Biologics / Analytical Characterization

Complete Materials Characterization of Your Biopharmaceutical

Any changes to your biotherapeutic drug development process, from the expression system to manufacturing process, impacts your product’s chemical stability, conformational stability, and resulting activities. It is important to characterize your biologic to de-risk downstream development.

Utilizing state-of-the-art equipment, our experienced scientists use stage-appropriate analytical, biophysical, and compendial testing techniques to characterize biologics.

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Analytical Characterization

Purity & Identity Assessments

Our analytical characterization capabilities include separation and quantitation using chromatographic, electrophoretic, and spectroscopic instrumentation. These purity assessments are typically part of a more extensive formulation or process endeavor but also act as a limited troubleshooting tool or feasibility study.

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Posttranslational Modifications

A thorough biologic characterization of the primary amino acid sequences informs formulation development, identifies stability concerns, and establishes the baseline for sample comparisons.

For example, certain post-translational modifications cause the biologic to degrade over time. Sidechain modifications also must be identified and quantified to determine the drug-to-antibody ratio (DAR) of antibody drug conjugates (ADCs) and identify sequence-specific modification sites.

Aggregation & Structural Assessments

Monitoring for protein aggregation early in the biotherapeutic development process helps predict their formation during processing, formulation, and contact material changes. Aggregation causes issues such as protein activity loss and immunogenicity on administration. It is thus imperative to monitor for both reversible or irreversible aggregates before they become a major concern.

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Additional Parenteral Quality Attributes

In addition to assessing the critical quality attributes of your biotherapeutic API, the parenteral’s solution properties are critical quality attributes that need to be measured and tracked. We routinely assess:

  • Viscosity
  • Osmolality
  • Density
  • Excipient Concentrations – PS80, Arginine, Sugar, etc.

Integrated Laboratory Services  

When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts add power to your project.