SILuMAb and SigmaMAb Antibody Standards for Mass Spec Analysis

SILuMAb is a critical tool for the assessment of the pharmacokinetic properties of biotherapeutics. It is a highly purified, stable isotope-labeled IgG monoclonal antibody expressed in a proprietary Sigma-Aldrich CHO cell line, grown in serum-free 13C6 15N4 Arg / 13C6 15N2 Lys-enriched media. Vertical integration of SILuMab into the LC/MS analytical workflow yields universal stable isotope-labeled tryptic peptides that are utilized as internal standards.

SILuMAb′s design is optimized to be used as an internal standard for quantitation of monoclonal antibodies as well as Fc-fusion therapeutics. Because of overlap with the common sequences in the Fc and light chain regions with candidate antibodies, SILuMAb provides universal utility, and thus eliminates the need for production of candidate-specific internal standards. Quantitative LC/MS assays utilizing SILuMAb offer advantages over traditional ELISA-based methods because of their superior specificity, sensitivity, and reduced matrix effects. As a full-length protein standard, SILuMAb is superior to horizontally-integrated labeled peptide standards in that it reduces errors associated with fractionation, enrichment, and proteolysis.

SILuMAb has been validated as an internal standard for quantitation of relevant biotherapeutics in a complex biological matrix by MRM-based LC-MS/MS:
  • SILuMAb yielded reproducible, linear curves from 6.4 μg/mL to 250 μg/mL without enrichment or depletion.
  • Good agreement was observed between multiple peptides derived from the same target.

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MSQC8 SigmaMAb Antibody Drug Conjugate (ADC) Mimic Antibody Cysteine-Fluorophore Conjugate Standard
MSQC4 SILuLite SigmaMAb Universal Antibody Standard human
MSQC9 SILuMAb Infliximab Stable-Isotope Labeled Monoclonal Antibody recombinant, expressed in CHO cells
MSQC6 SILuMAB K1 Stable-Isotope Labeled Universal Monoclonal Antibody recombinant, expressed in CHO cells
MSQC7 SILuMAb K4 Stable-Isotope Labeled Universal Monoclonal Antibody recombinant, expressed in CHO cells
MSQC10 SILuMAb Mouse Stable-Isotope Labeled Monoclonal Antibody from mouse, recombinant, expressed in CHO cells New
MSQC5 SILuMab Stable Isotope-Labeled Monoclonal Antibody Glycan Standard Mouse IgG2b
MSQC3 SILuMAB Stable-Isotope Labeled Universal Monoclonal Antibody Standard human recombinant, expressed in CHO cells