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HTRF CHO Host Cell Protein Detection Kit HTRF®

The CHO Host Cell Protein kit is designed for the quantitative assessment of Chinese Hamster Ovary (CHO) cell contaminants in bioprocess operations. The CHO HCP Detection Kit is also available in AlphaLISA® format as an orthogonal technology. Learn about the AlphaLISA CHO HCP Detection Kit here

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  • No-wash No-wash
  • All inclusive kit All inclusive kit
  • Faster and more convenient than ELISA Faster and more convenient than ELISA

The CHO Host Cell Protein kit is designed for the quantitative assessment of Chinese Hamster Ovary (CHO) cell contaminants in bioprocess operations. The CHO HCP Detection Kit is also available in AlphaLISA® format as an orthogonal technology. Learn about the AlphaLISA CHO HCP Detection Kit here

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Overview

The CHO Host Cell Protein (HCP) kit measures contaminants originating from the CHO cells used to manufacture therapeutic antibodies. The kit can be used for the quantification of CHO HCP proteins in routine bioprocess operations, from the completely raw harvest material to the final product. The simple and robust procedure benefits from increased throughput compared to ELISA.

Benefits

  • FAST CHO HCP QUANTIFICATION
  • BIOPROCESS QUALITY CONTROL
  • BIOPROCESS OPTIMIZATION

Assay principle

The CHO Host Cell Protein (HCP) assay is a sandwich immunoassay. The assay uses a specific and qualified anti-CHO HCP polyclonal antibody pool, labelled with Eu3+-Cryptate and t d2. The specific signal is proportional to the concentration of CHO HCP present in the sample. This homogeneous assay requires only a single reagent addition (by premixing the detection reagents), and an overnight incubation, for the quantitative detection of CHO HCP.

Principle of the HTRF CHO HCP assay

Assay protocol

The CHO HCP assay protocol, using a 384-well small volume white plate,  is described on the right. 16 µL of sample or standard are dispensed directly into the detection plate for detection by HTRF® reagents. The antibodies labeled with the HTRF donor and acceptor can be pre-mixed and added in a single dispensing step, to further streamline the assay procedure. This protocol requires only 1  overnight incubation period.

Protocol of the HTRF CHO HCP assay

HTRF CHO HCP assay specifications

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Sample volume

16 µL

Final assay volume

20 µL

Time to results

Overnight at RT

Detection limit

0.8 ng/mL

Dynamic range

3.6 to 400 ng/mL

Sample compatibility

From raw harvest material to the final biotherapeutic product

HTRF CHO HCP assay standard curve

HTRF CHO HCP assay specifications

CHO HCP standard curve

Precision

Intra-assay (n=24)


Sample

Mean [CHO HCP] (ng/mL)

% CV

1

10

6%

2

29

3%

3

97

3%

4

306

4%

Each of the 4 samples was measured 24 times, and the %CV on concentration was calculated for each sample.

Inter-assay (n=4)


Sample

Mean [CHO HCP] (ng/mL)

%CV

1

10

9%

2

29

5%

3

97

4%

4

292

5%

Each of the 4 samples was measured in 4 independent experiments by 4 different operators, and the  concentration % CV was calculated for each sample.

Antigen spike and recovery

Sample

[CHO HCP Standard] (ng/mL)

[CHO-DG44 HCP Sample] added (ng/mL)

Expected [CHO HCP] (ng/mL)

Measured [CHO HCP] (ng/mL)

% Antigen recovery

1

14

7

21

21

104%

2

14

14

28

28

101%

3

14

23

37

41

112%

4

46

26

72

69

97%

5

46

45

91

94

104%

6

46

88

134

138

103%

7

95

45

140

151

107%

8

95

88

183

202

111%

9

95

162

257

279

109%

Three different levels of CHO HCP Standard were independently mixed with three different sample concentrations (cell culture supernatant from a biomanufacturing process using the CHO-DG44 cell line). The total measured concentrations were compared to the theoretical ones, and expressed as % Antigen recovery (acceptance criteria: 85-115%).

Dilutional linearity

CHO-S HCP sample

Dilution Factor

Expected [CHO HCP] (ng/mL)

Measured [CHO HCP] (ng/mL)

% Recovery

Neat

426

426

 100%

2

213

226

106%

4

106

111

104%

8

53

57

106%

16

27

28

107%

32

13

13

98%

64

7

7

101%

128

3

4

106%

Samples were from cell culture supernatant from a biomanufacturing process using the CHO-S cell line diluted in the kit's Diluent 5. The recovery % obtained from these experiments show the good dilutional linearity of the assay (dilution test acceptance criteria: 80-120%)

CHO-K1 HCP sample

Dilution Factor

Expected [CHO HCP] (ng/mL)

Measured [CHO HCP] (ng/mL)

% Recovery

Neat

344

344

 100%

2

172

173

100%

4

86

88

102%

8

43

45

105%

16

22

24

111%

32

11

13

119%

Samples were from cell culture supernatant from a biomanufacturing process using the CHO-K1 cell line and diluted in the kit's Diluent #5. The recovery % obtained from these experiments show the good dilutional linearity of the assay (dilution test acceptance criteria: 80-120%)

Product Insert CHO HCP Kit2 / 64CHOPEG-64CHOPEH

64CHOPEG-64CHOPEH - Product Insert

Guide for CHO HCP detection

This guide highlight the challenges associated with CHO HCPs in the biopharmaceutical production and presents the benefits of using HTRF and AlphaLISA assays instead of the actual ELISA standard. - Guides

Streamline the CHO HCP impurity quantification workflow with new high throughput, no-wash HTRF and AlphaLISA CHO Host Cell Protein Kits

This application demonstrates the many ways in which HTRF and AlphaLISA kits can improve the workflow for CHO HCP detection - Application Notes

Plate Reader Requirement

Choosing the right microplate reader ensures you’ll get an optimal readout. Discover our high performance reader, or verify if your lab equipment is going to be compatible with this detection technology.

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