Biopharmaceuticals are changing medicine, and analysis of their structure and safety demand skills beyond those applied to traditional pharmaceuticals. For proteins and polypeptides, questions such as protein structure, post-translational modifications, physicochemical properties and aggregation also come into play. For proteins and peptides produced in culture, impurities arising from the host cell is also important.

With a number of biopharmaceutical products due to go off patent in the next few years, the market for biosimilars is set to grow significantly. To gain regulatory approval, significant analytical data is required to confirm that the product has the appropriate quality, safety and efficacy as the originator molecule.

RSSL provides a comprehensive service to support you in ensuring the identity, purity, stability and quality of your biopharmaceutical products. Our analyses will help you understand parameters that might impact quality and safety. We can supply the robust scientific data to support submission and regulatory compliance.

Our expert teams have a wealth of experience in protein characterisation, host cell DNA quantification, host cell protein quantification, glycosylation profiling and carbohydrate determination.

Glycosylation and Monosaccharide Determination

We can help define the important glycosylation features of your biologic whether novel, biosimilar or biobetter, to support pre-clinical and clinical studies, regulatory submission and batch release.

Using technical experts, we build up a complete picture of your biopharmaceutical’s glycosylation: structures of individual oligosaccharides, relative amounts, monosaccharide analysis and site(s) of attachment.

Biopharmaceutical Services

  • Biopharmaceutical Protein Characterisation

    RSSL offers a wide range of protein characterisation techniques, our experts welcome specific method development and validation projects that support research, product development and quality control testing.

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  • Sub-visible Particle Analysis

    We can detect and quantify sub-visible particles in a wide range of injectables, parenterals, opthalmics and drug production/storage/delivery components.

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