Protein A ELISA Kit for Engineered Variant

Catalog #: BPPAEV0 Datasheet / COA / SDS

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BPPAEV0

Protein A Engineered Variant Standard Curve

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Summary Recovery Linearity Data Examples Product Datasheets Preparation and Storage Background Related Research Areas

Protein A ELISA Kit for Engineered Variant Summary

Assay Length

2.5 hours

Sample Type & Volume Required Per Well

Biosimilar Therapeutic Antibody (10 uL)

Sensitivity

0 pg/mL

Assay Range

23.4 - 1,500 pg/mL (Biosimilar Therapeutic Antibod)

Cross-reactivity

< 0.5% cross-reactivity observed with available related molecules.< 50% cross-species reactivity observed with species tested.

Interference

No significant interference observed with available related molecules.

Product Summary

This Protein A ELISA is intended for detection of engineered Protein A constructs such as MabSelect SuRe™ in Bioprocess manufacturing applications. There are occasions where Protein A or its fragments leach from a purification column and remain bound to the Fc region of a therapeutic antibody. This must be avoided in order to preclude any adverse effects of Protein A on the patient, particularly in instances where antibodies are manufactured for pharmaceutical uses. This ELISA can be utilized as a Protein A ligand leaching quality control step in the mAb development workflow.

Recovery

The recovery of Protein A Engineered Variant spiked into biosimilar therapeutic antibody samples to levels throughout the range of the assay was evaluated. Each user should qualify their sample matrices for accurate recovery. For sample matrices oth

Sample Type	Average % Recovery	Range %
Biosimilar Therapeutic Antibody (n=4)	96	84-122

Linearity

To assess the linearity of the assay, biosimilar therapeutic antibody samples spiked with high concentrations of Protein A Engineered Variant were serially diluted with calibrator diluent to produce samples with values within the dynamic range of the assay.

Scientific Data

N/A

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Protein A Engineered Variant Standard Curve

Product Datasheets

Product Datasheet

COA

SDS

Preparation and Storage

Shipping

The product is shipped at ambient temperature. Upon receipt, store it immediately at the temperature recommended below.

Storage

Store the unopened product at 2 - 8 °C. Do not use past expiration date.

Background: Protein A

Protein A is a Staphylococcus aureus cell wall constituent that is characterized by its binding affinity to the Fc portion of some immunoglobulins, especially those of the IgG class. Because of this property, it is often utilized for microscopic visualization of molecules and to purify antisera. Protein A has also been used for the treatment of proteinuria in nephrotic syndrome, and severe autoimmune diseases such as rheumatoid arthritis, coeliac disease, and systemic lupus erythematosis.

Entrez Gene IDs:

3919448 (S. aureus)

Alternate Names:

Immunoglobulin G binding protein A; PROA; Protein A; Protein-A; SPA; Staphylococcal protein A