Protein A ELISA Kit

Catalog #: BPPA00 Datasheet / COA / SDS

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

Protein A ELISA Kit Summary

Assay Length

2.5 hour

Sample Type & Volume Required Per Well

Biosimilar Therapeutic Antibody (10 pg/mL)

Sensitivity

0 pg/mL

Assay Range

46.9 - 3,000 pg/mL

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 natural and recombinant Protein A 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.

Precision

Intra-Assay Precision (Precision within an assay) Three samples of known concentration were tested twenty times on one plate to assess intra-assay precision

Inter-Assay Precision (Precision between assays) Three samples of known concentration were tested in twenty separate assays to assess inter-assay precision. Assays were performed by at least three technicians using two lots of components

Biosimilar Therapeutic Antibody

	Intra-Assay Precision			Inter-Assay Precision
Sample	1	2	3	1	2	3
n	20	20	20	20	20	20
Mean (pg/mL)	157	507	1519	148	458	1442
Standard Deviation	4.9	13.6	42.3	12.2	28.9	86.8
CV%	3.1	2.7	2.8	8.3	6.3	6

Recovery

The recovery of Protein A 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 other than PBS, further qual

Sample Type	Average % Recovery	Range %
Biosimilar Therapeutic Antibody (n=4)	101	88-113

Linearity

To assess the linearity of the assay, biosimilar therapeutic antibody samples spiked with high concentrations of Protein A 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 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