CHO HCP ELISA Kit

Name: CHO HCP ELISA Kit
SKU: DEIABY268
Rating: 5 (1 reviews)

Regulatory status: For research use only, not for use in diagnostic procedures.

COA

SDS

Datasheet

Summary

Sample

Biological products

Detection Method

Sandwich-ELISA

Intended Use

This kit is designed for the quantitative analysis of host cell protein (HCP) residuals in protein-based drugs produced using CHO cells as the expression system.

Contents of Kit

No.	Components	Size	Storage Conditions
1	Pre-coated Microplate	96T × 1 plate (strips)	2-8°C (Sealed)
2	Standard Stock Solution (500 μg/mL)	50 μL × 1 vial	2-8°C
3	Detection Antibody (100×)	150 μL × 1 vial	2-8°C
4	TMB Substrate	10 mL × 1 bottle	2-8°C (Protect from light)
5	Stop Solution	10 mL × 1 bottle	2-8°C
6	Wash Buffer (20×)	10 mL × 5 bottles	2-8°C
7	Diluent (10×)	10 mL × 1 bottle	2-8°C
8	Plate Sealer	4 sheets

Storage

Store kit at 2 - 8°C. Do not use kit after expiration date.

Performance Characteristics

Advantages
• Broad Coverage: The antibodies possess strong HCP recognition capability, achieving >80% coverage with stable performance.
• High Titer: The antibodies used in this kit demonstrate a titer of up to 10⁶ when tested by indirect ELISA.
• High Sensitivity: Serum antibodies are purified using affinity chromatography to minimize non-specific antibodies.
• High Stability: The production process incorporates broad-spectrum protein stabilizers and specialized microplate treatment to enhance the thermal stability of standards and plates, ensuring result reproducibility.
• Robust Applicability: The kit has been tested under varying reaction temperatures (20-30°C) and incubation times (±10 minutes), showing good reproducibility.
• Optimized Diluent: The use of an optimized sample diluent reduces non-specific adsorption during sample testing, resulting in very low background color, which facilitates accurate concentration determination.

Precision

Intra-assay CV%: 5 - 6%
Inter-assay CV%: 7 - 7.7%

Sensitivity

LOD: 0.19 ng/mL
LOQ: 0.78 ng/mL

General Description

The Chinese Hamster Ovary (CHO) cell line is widely used for the expression of therapeutic proteins. During protein expression, cell apoptosis and lysis can release over a thousand different host proteins into the culture medium. Many of these HCPs are highly immunogenic and may trigger adverse toxic or immune reactions, compromising product safety and quality.
Reducing HCP residues to the lowest possible level is a primary goal of downstream biopharmaceutical processing. Due to its high sensitivity, the Enzyme-Linked Immunosorbent Assay (ELISA) is designated as the "gold standard" for HCP detection by global regulatory agencies.

Standard Curve