Although the majority of biological products in development are based on a monoclonal antibody framework, a significant number of existing and new therapies are not antibody based. These fall broadly into four categories:

  • Enzyme replacement therapies
  • Hormones, cytokines and cell growth factors
  • Blood factors
  • Non antibody scaffolds

ICH Q6B is the overarching guideline for defining the characterisation, comparability and release testing requirements of these molecules.  

Protein, Peptide and Glycoprotein analysis
Protein, Peptide and Glycoprotein analysis 

Non-antibody proteins vary in their complexity. Glycosylation patterns of antibodies are relatively simple because an antibody has only one glycan site on each heavy chain with a simple glycosylation profile. However, proteins with multiple glycosylation sites will require glycan release from each of these sites, coupled with analysis and structural characterisation. Typically, a more diverse and complex range of glycans are observed, requiring a greater level of analysis, and more complex data interpretation.

During development a bank of knowledge is acquired about the active molecule, including details of the batch-to-batch variability. This is used later to demonstrate adequate control over the manufacturing process. If variability is low, a regulator may permit later reduction in analytical burden, but to do this the manufacturer must demonstrate that changes in the protein glycan profile do not alter the core functionality of the product nor lead to any adverse patient reactions.

RSSL have the expertise in peptide, protein and glycosylation analysis to guide you through the various analytical steps required to fully characterise your biomolecule. RSSL expertise extends beyond the current norm of antibody analysis to the more complex interpretation and understanding of non-antibody-based biomolecules. Though many of the methods used are similar for antibody and non-antibody scaffolds, it is RSSL’s ability to fulfill the requirements of more complex studies  that differentiate our experimental offerings.

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