During drug development, it is important to understand your protein of interest and how your manufacturing processes impact the quality and safety of your product. Having control over the manufacturing process, alongside knowing the impact of any variation, is critical to fully understanding your large molecule and is a vital regulatory requirement.
RSSL has the expertise in peptide, protein and glycosylation analysis to guide you through the various analytical steps required to fully characterise your biomolecule. Our services can help you meet the characterisation, comparability and release testing requirements as outlined in ICH Q6B.
Our expertise extends beyond antibody analysis to more complex interpretation and understanding of non-antibody-based biomolecules. Whilst many of the methods used are similar for antibody and non-antibody products, RSSL has the ability to fulfil the requirements of both simple and more complex studies.