glyco application

Biotherapeutics and Antibody Analysis

Because of their high specificity and targeted effects, monoclonal antibodies (mAbs), Fc fusions and antibody-drug conjugates (ADCs) are the new generation of cancer and autoimmune disease therapies. Modern principles of Quality by Design (QbD) mandate controlled production and dedicated quality controls to ensure their effectiveness and safety.

  • The majority of biotherapeutics are glycosylated proteins produced recombinantly in mammalian cells.
  • N-glycans are essential for effector functions in mAbs, but they can also carry xenoantigens (i.e. α-Gal epitope).
  • The impact of glycosylation on protein function, structure and safety makes it a critical quality attribute (CQA), measured throughout development and production. 
  • Additionally, batch-to-batch glycosylation consistency is used as a surrogate measure of process control.
  • Analysis of sequence variants is facilitated by glycan removal.
  • Antibody fragmentation with specific proteases allows the analysis of intact, glycosylated, Fc and Fab fragments.

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References:

  1. Zhang L, et al (2016) MAbs. 2016; 8(2):205-15. PMID 26599345.
  2. Hakemeyer C, et al (2016) Biologicals 2016; 44(5):306-18. PMID 27464992.