Biopharmaceutical characterisation studies 

RSSL can provide early characterisation of a wide range of compounds, therapeutic modalities and reference standards in respect of their potency, purity and physical properties.

 

To support you in the early phases of drug development, RSSL offers a comprehensive range of analytical techniques including our biopharmaceutical analysis to generate phase-appropriate methods to characterise your compound of interest. Our expert teams work across our labs to deliver these methods in accordance with ICH Q6B and EMA guidelines. 

 

Our services apply to monoclonal antibodies, antibody fragments, fusion proteins, conjugated proteins, intact RNA, viral vectors and lipid nanoparticles. 

Our broad extensive analytical techniques range from simple biopharmaceutical testing, such as pH and appearance, to mass spectrometry and capillary electrophoresis, as well as bespoke potency and functional assays, including bioassays. We also support with method development, transfer and validation

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For protein therapeutics, our characterisation studies include: 

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