A large number of innovator biotherapeutics are currently losing patent protection, resulting in an increased interest to develop biosimilar therapeutic proteins. A key step to proving biosimilarity is to ensure proper N-glycosylations. The presence or the absence of a sialic acid can dramatically affect the pharmacokinetics of a protein. Glycoprotein sialylations are critical to the bioavailability, stability, metabolism, and immunogenicity of therapeutic proteins. As a result, such proteins are routinely analyzed to determine sialylation amount and identity.
High-performance anion-exchange chromatography with pulsed amperometric detection (HPAE-PAD) is a well-established method for the determination of sialic acids.
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