CRM197 is a nontoxic mutant of diphtheria toxin in which the glutamic acid (Glu) at position 52 has been replaced by glycine (Gly), thereby losing the ADP-ribosyltransferase activity of the original toxin. Like diphtheria toxin, CRM197 provides a single polypeptide chain of 535 amino acids (~58.4 kD) comprising two subunits connected by disulfide bonds.
CRM197 has been incorporated into several approved conjugate vaccines that are widely used as a carrier protein in conjugate vaccines.
Hibtiter is an approved conjugate vaccine containing CRM197 to prevent Haemophilus influenza type b. The FDA approved two CRM197-conjugated polysaccharide vaccines, Prevnar 13 (13-valent) and Prevnar 20 (20-valent), for the prevention of Pneumococcal infections, which were developed by Wyeth (now Pfizer). Menveois a meningitis ACWY vaccine that also provides a CRM197-conjugated polysaccharide vaccine. It was developed by GlaxoSmithKline (GSK). A nontoxic variant of the diphtheria toxin CRM197 was isolated and purified from cultures of Corynebacterium diphtheriae strains that are in the above vaccines.
Merck used recombinant CRM197 generated in Pseudomonas fluorescens in its FDA- and EMA-approved pneumococcal vaccine, Vaxneuvance.
Studies have also shown that recombinant expression of soluble CRM197 in Escherichia coli (E. coli) has achieved multi-gram/L yield.
Yaohai Bio-Pharma offers One-Stop CDMO Solution for CRM197
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