Chinese hamster ovary (CHO) cells are widely used in the pharmaceutical industry to produce antibodies and recombinant proteins for biomedical research, diagnostics, and therapy.

Host Cell Protein (HCP) impurity levels must be monitored throughout the purification process and in final product, and should be reduced to the lowest practical levels since HCPs may be immunogenic, interfere with drug efficacy, or impact drug stability.

Gyrolab CHO HCP Kits provide the following benefits when used for the detection of CHO HCPs in bioprocess samples:

  • Broad coverage of critical HCPs– A 360-HCP approach results in coverage of ≥ 80%
  • Automates HCP detection – 10 minutes hands-on time and results in 90-minute run time
  • Robust assays – Automated Gyrolab pipetting reduces variability and the need for repeats
  • Precise, accurate results – Lowers the risk of missing important HCPs

Figure: Example standard curve data from an assay run using Gyrolab CHO HCP Kit Type B

 

Gyrolab CHO HCP Kits provide robust sandwich immunoassays with low ng/mL sensitivity. The assays are developed with antibodies raised by immunizing goats (kit types A, B) or rabbits (kit types C, D) against antigen prepared from total and fractionated HCPs obtained from mock fermentation of CHO-K1 and CHO-S. The reagents are generic for HCPs that could co-purify with the drug product, with coverage assessed by 2D DIGE analysis, and are fully tested and validated on Gyrolab. Gyrolab CHO HCP Kits can be used for cell line development, process development, and routine final product release.

Product Number

Product Name

Species

HCP

Description

P0021106 Gyrolab CHO HCP Kit A Goat Total HCP Includes capture and detect reagents, disc, pre-diluted standard, sample dilution buffer, wash buffer and accessories required to generate 96 datapoints (1 discs)
P0021107 Gyrolab CHO HCP Kit B Goat Fractionated HCP
P0021108 Gyrolab CHO HCP Kit C Rabbit Total HCP
P0021109 Gyrolab CHO HCP Kit D Rabbit Fractionated HCP

 

Gyrolab ordering information
Contents
Additional Optional Products
Downloads

Gyrolab ordering information

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Gyrolab CHO HCP Kit A

Includes capture and detect reagents, disc, pre‑diluted standard, sample dilution buffer, wash buffer and accessories required to generate 96 datapoints (1 disc) P0021106

Gyrolab CHO HCP Kit B

Includes capture and detect reagents, disc, pre‑diluted standard, sample dilution buffer, wash buffer and accessories required to generate 96 datapoints (1 disc) P0021107

Gyrolab CHO HCP Starter Set

Includes capture and detect reagents for all kit types as well as pre-diluted standard and all consumables required to quickly and easily assess all 4 kits to easily choose the most appropriate kit type for a specific process (2 discs) P0021124

Gyrolab CHO HCP Kit C

Includes capture and detect reagents, disc, pre‑diluted standard, sample dilution buffer, wash buffer and accessories required to generate 96 datapoints (1 disc) P0021108

Gyrolab CHO HCP Kit D

Includes capture and detect reagents, disc, pre‑diluted standard, sample dilution buffer, wash buffer and accessories required to generate 96 datapoints (1 disc) P0021109

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Contents

 

Product Name

Quantity

Description

Gyrolab CHO HCP Reagent Set 1 Biotinylated capture reagent, Alexa Fluor™ 647 labeled detection reagent, pre diluted Standard curve
Gyrolab Bioaffy 4000 HC 1 Microfluidic disc with 4000 nL sample chamber, High Capacity, 96 datapoints
Gyrolab Assay Wash Buffer Duo 1 Wash buffer 1 (2 mL) and Wash buffer 2 (2 mL)
Gyrolab HCP Sample Dilution Buffer 1 HCP Sample dilution buffer (25 mL)
Additional Gyrolab consumables   Contains 96-well plate: 0.2 mL skirted PCR plates (x3), microplate foils (x3), Gyrolab Wash Buffer pH 11 (x1)

 

Additional Optional Products

Product Number

Product Name

Description

P0021119 Gyrolab CHO HCP Stock Standard 200 µL of antigen concentrate from mock fermentation of CHO-K1 and CHO-S (1500 ng/mL)
P0021110 Gyrolab CHO HCP Reagent Set A Gyrolab Reagent Set with antibodies generated in Goat against Total HCP
P0021111 Gyrolab CHO HCP Reagent Set B Gyrolab Reagent Set with antibodies generated in Goat against Fractionated (low molecular weight) HCP
P0021112 Gyrolab CHO HCP Reagent Set C Gyrolab Reagent Set with antibodies generated in Rabbit against Total HCP
P0021113 Gyrolab CHO HCP Reagent Set D Gyrolab Reagent Set with antibodies generated in Rabbit against Fractionated (low molecular weight) HCP
P0020852 Gyrolab Bioaffy 4000 HC Assay Toolbox Contains 1 microfluidic disc and all buffers and consumables needed to generate 96 data points.