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Merck
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Key Documents

ABK0007

Sigma-Aldrich

HercBridge ELISA Kit

Synonym(s):

Protein Conformational Array Herceptin Biosimilar, Protein Conformational Array Trastuzumab

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About This Item

UNSPSC Code:
41116158
NACRES:
NA.32

antibody form

IgG fraction of antiserum

species reactivity

human (Human IgG)

shipped in

wet ice

storage temp.

2-8°C

General description

A Protein Conformational Array (PCA) in a sandwich ELISA format where the plate is coated with a panel of antibodies raised against peptides derived from the full length protein sequence of Trastuzumab. Taken individually, each of these antibodies is strongly antigenic to the peptide sequence that was used in its production. However, when these peptides are incorporated into a full length correctly folded protein, the antigenicity of many of them is masked by the three dimensional structure of the protein and only a limited number of the antibodies respond. The result is a histogram which can be likened to a ‘fingerprint′ for correctly folded Trastuzumab. For a Herceptin Biosimilar, if the protein is correctly folded and glycosylated, the ‘fingerprint′ will match that of Trastuzumab. If it is not correctly folded, previously masked peptide sequences will be exposed and will be recognized by the antibody made to that exposed sequence. In this way, changes in the ‘fingerprint′ generated by the ELISA will point out differences between the Biosimilar and authentic Trastuzumab.

Application

For research use only. Not for use in diagnostic procedures.

Pictograms

Corrosion
GHS05

Signal Word

Warning

Hazard Statements

H290 - H315 - H319

Hazard Classifications

Eye Irrit. 2 - Met. Corr. 1 - Skin Irrit. 2

Storage Class Code

8A - Combustible, corrosive hazardous materials

WGK

WGK 3

Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

EU REACH Annex XVII (Restriction List)

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Jihun Lee et al.
mAbs, 10(4), 547-571 (2018-02-28)
The evaluation of analytical similarity has been a challenging issue for the biosimilar industry because the number of lots for reference and biosimilar products available at the time of development are limited, whilst measurable quality attributes of target molecule are
Xing Wang et al.
Frontiers in pharmacology, 4, 103-103 (2013-08-24)
Antibody arrays were developed to probe a monoclonal antibody's three-dimensional structure (3-D structure). Peptides with overlapping regions were designed to cover the whole mAb light chain and heavy chain, respectively, and used to generate polyclonal antibodies after the conjugation of
Yuanli Song et al.
mAbs, 10(3), 397-405 (2018-01-10)
The elucidation of antibody higher order structure (HOS) is critical in therapeutic antibody development. Since HOS determines the protein bioactivity and chemo-physical properties, this knowledge can help to ensure that the safety and efficacy attributes are not compromised. Protein conformational
Biosimilar mAb in-process Sample Higher Order Structure Analysis with Protein Conformational Array ELISA.
Michael Davies, Gan Wang, Jian Gong, Guofeng Fu and Xing Wang
Pharmaceut. Res., 1-11 (2016)
Soon Kwan Jung et al.
mAbs, 6(5), 1163-1177 (2014-12-18)
Remsima (infliximab) was recently approved as the world's first biosimilar monoclonal antibody (mAb) in both the European Union and Korea. To achieve this, extensive physicochemical characterization of Remsima in relation to Remicade was conducted in order to demonstrate the highly

Articles

Protein Conformation Array Multiplexing

Monoclonal antibodies (mAbs) are the fastest growing class of human therapeutics within the field of biologics, having predicted worldwide sales of $125 billion by 2020 based on current approval rates.

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