Saccharomyces cerevisiae‌ HCP ELISA Kit

Name: Saccharomyces cerevisiae HCP ELISA Kit
SKU: DEIABY2610
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

S.cerevisiae HCP ELISA kit is designed for the quantitative analysis of host cell protein (HCP) residuals in protein-based drugs produced using Saccharomyces cerevisiae 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%: 2 - 8%
Inter-assay CV%: 2.07 - 5.44%

Sensitivity

LOD: 1.56 ng/mL
LOQ: 3.125 ng/mL

General Description

Saccharomyces cerevisiae is a widely used expression system for recombinant protein production. During the expression of target proteins, cell death and lysis can release over a thousand different host proteins into the culture medium. Many of these proteins are highly immunogenic and may trigger adverse toxic or immune reactions, compromising product safety and quality.
Therefore, it is essential to reduce Host Cell Protein (HCP) residuals to minimal levels. During the development of downstream purification processes, a scientifically sound method for determining HCP concentration in final or intermediate products is necessary. Enzyme-Linked Immunosorbent Assay (ELISA) is the "gold standard" for HCP detection designated by global regulatory agencies due to its high sensitivity.

Standard Curve