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Characterization Services

The primary function of biopharmaceutical development is to demonstrate that the investigational drug, including recombinant proteins or monoclonal antibodies, is both safe and efficacious for human use. One aspect of demonstrating safety relies on comprehensive understanding of both the drug substance and drug product, both from a physicochemical and biological viewpoint.
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Meeting regulatory demands through robust analytical characterization

Regulatory expectation is that any investigational biopharmaceutical will be thoroughly characterized using a wide range of analytical techniques. Due to the highly complex nature of biopharmaceuticals, this is not a trivial exercise, often involving orthogonal analytical techniques to gain deep understanding of the biopharmaceutical product, including:

Primary structure

A critical step in establishing and maintaining the quality, safety and efficacy of any protein biologic is the effective characterization of its primary structure

Primary Structure Services
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Higher-order structure (HOS)

Higher-Order Structure (HOS) refers to the three-dimensional arrangement of a protein’s secondary, tertiary and quaternary structures

HOS Services
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Biological activity

Potency is the only critical quality attribute (CQA) that measures the biological activity of a therapeutic, associated with the intended mechanism of action (MOA)

Biological Activity Services
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