Highly sensitive measurement, detecting as little as 9.01 pg/ml (<1 ppm) of Protein A residuals in purified humanized mAb preparations
Ensures accurate results as it recognizes several constructs of Protein A
High throughput format with results in < 3 hours for up to 37 samples in duplicate
Cost-effective solution compared to other technologies, providing a lowercost-per-test
Useful for contamination analysis and measurement of Protein A variants in monoclonal antibody preparations
The Protein A EIA kit is a colorimetric immunometric enzyme immunoassay kit with results in < 3 hours. Absorbance is read at 450 nm. Ultra-sensitive quantification ( < 1 ppm ) of Protein A residuals in purified humanized monoclonal antibody preparations. This kit recognizes four different Protein A constructs.
Assay recognition of different Protein A constructs, post boiling. Resulting concentrations were interpolated from kit standard curve. Percent recovery calculated by dividing observed concentration by expected concentration. A: Natural Protein A from S. aureus (Millipore), n=9; B: Recombinant Protein A from E. coli (Repligen), n=9; C: Recombinant Cys-Protein A from E. coli (GE), n=12; and D: Recombinant alkaline-resistant Protein A variant from E. coli (MabSelet SuRe from GE), n=12; graphical data represents statistical mean +/- 1 standard deviation.
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Product Details
Sensitivity:
9.01 pg/ml (range 15.63 - 1,000 pg/ml)
Assay Time:
<3 hours
Applications:
ELISA, Colorimetric detection
Application Notes:
For the quantitative determination of residual protein A contamination in protein A purified IgG preparations from any species.
Staphylococcus aureus Protein A is a 42 kDa cell wall constituent that is characterized by its binding affinity to the Fc portion of some immunoglobulins, especially the IgG class. The IgG binding domain (domain B) consists of three anti-parallel alpha-helices, the third of which is disrupted when the protein is complexed with Fc. Protein A is commonly used to purify antisera and in commonly used immunodetection and visualization techniques. Protein A participates in a number of protective biological functions including anti-tumor, toxic and carcinogenic activities, thus necessitating the removal of potential Protein A contaminants from antibody preparations for therapeutic use.
Technical Info/Product Notes:
Assay recognition of different Protein A constructs from natural Protein A from S. aureus (M), recombinant Protein A from E. coli (R), recombinant Cys-Protein A from E. coli (G), and recombinant alkaline-resistant Protein A variant from E. coli (S) were tested and the resulting concentrations were interpolated from kit standard curve and displayed in the figure provided.
An enhanced regeneration strategy to improve microbial control and prolong resin lifetime for Protein A resin in large-scale monoclonal antibody (mAb) purification: T. Zhou, et al.; J. Biotechnol. 289, 118 (2019), Application(s): ELISA using antibody preparation, Abstract;
Indirect monitoring of protein A biosynthesis in E.coli using potentiometric multisensor system: D. Kirsanov, et al.; Sensors and Actuators B: Chemical 238, 1159 (2017), Application(s): Measurement of Protein A,
Sensitive (10 ng/ml) ELISA for the quantitative determination of host cell protein contamination in bulk products expressed in Chinese Hamster Ovary (CHO) expression systems.
Sensitive (30 ng/ml) ELISA for the quantitative determination of host cell protein contamination in bulk products expressed in E. coli expression systems.
