This kit was developed using broadly reactive polyclonal antibodies to the hundreds of different HCPs and is intended for use in determining the presence of E.coli host cell protein contamination in products manufactured by recombinant expression. Our assay validation has determined that the LOD for this kit is ~0.2ng/mL.

Host Cells used for recombinant expression are complex systems containing hundreds to thousands of host cell proteins (HCPs) that can contaminate biopharmaceutical products. Failure to sufficiently remove contaminants early in drug development can result in reduced drug efficacy or adverse patient reactions.

Regulations require HCPs be reduced to the lowest levels possible. Our generic ELISA kits are useful in both process development and process validation. Using these kits in the earliest phase of product development can provide relevant and specific data directing process improvement and decreasing the levels of HCP contamination.

In quality control applications, subject to thorough validation and qualification by each laboratory, these kits may also be useful for lot release testing.

相關產品：

Product Catalog # Description

A549 HCP ELISA kit F230 Host cell protein assay, 96 tests

A549 HCP Western Blot Kit F235 Host cell protein assay, 5 mini blots

BHK HCP ELISA Kit F510 Host cell protein assay, 96 tests

Bovine IgG ELISA Kit F070 Bioprocess contaminant assay, 96 tests

Bovine Plasma Protein ELISA Kit F290 Bioprocess contaminant assay, 96 tests

BSA ELISA Kit F030 Bioprocess contaminant assay, 96 tests

Bovine Transferrin ELISA Kit F120 Bioprocess contaminant assay, 96 tests

CHO HCP ELISA Kit F015 Host cell protein assay, 96 tests

CHO HCP Western Blot Kit F060 Host cell protein assay, 5 mini blots

CHO-CM ELISA Kit CM015 Host cell protein assay, 96 tests

CHO-CM Western Blot Kit CM060 Host cell protein assay, 5 mini blots

CHO HCP ELISA Kit, 3G F550 Host cell protein assay, 96 tests

E. coli HCP ELISA Kit F410 Host cell protein assay, 96 tests

E. coli HCP Western Blot Kit F415 Host cell protein assay, 5 mini blots

Goat Casein HCP ELISA Kit F420 Host cell protein assay, 96 tests

Goat IgG ELISA Kit F210 Bioprocess contaminant assay, 96 tests

Total Goat Milk Proteins ELISA kit F240 Host cell protein assay, 96 tests

Total Goat Milk Proteins WB kit F245 Host cell protein assay, 5 mini blots

Human Albumin ELISA Kit F055 Bioprocess contaminant assay, 96 tests

Human IgA ELISA Kit F165 Bioprocess contaminant assay, 96 tests

Human IgG-total ELISA Kit F160 Bioprocess contaminant assay, 96 tests

Human IgM ELISA Kit F170 Bioprocess contaminant assay, 96 tests

HEK 293 HCP ELISA Kit F650 Host cell protein assay, 96 tests

Human Transferrin ELISA Kit F035N Bioprocess contaminant assay, 96 tests

Insect Cell SF9 HCP ELISA Kit F020 Host cell protein assay, 96 tests

Insect Cell SF9 Western Blot Kit F125 Host cell protein assay, 5 mini blots

Insulin ELISA Kit F040 Bioprocess contaminant assay, 96 tests

Lactococcus lactic HCP ELISA Kit F490 Host cell protein assay, 96 tests

Lactococcus lactic HCP WB Kit F495 Host cell protein assay, 5 mini blots

Mouse Total IgG ELISA Kit F049 Bioprocess contaminant assay, 96 tests

Mouse IgG1 ELISA Kit F045 Bioprocess contaminant assay, 96 tests

Mouse IgG2a ELISA Kit F046 Bioprocess contaminant assay, 96 tests

Mouse IgG2b ELISA Kit F047 Bioprocess contaminant assay, 96 tests

Mouse IgM ELISA Kit F090 Bioprocess contaminant assay, 96 tests

MRC5 HCP ELISA Kit F300 Host cell protein assay, 96 tests

NS/0 HCP ELISA kit F220 Host cell protein assay, 96 tests

NS/0 HCP Western Blot kit F225 Host cell protein assay, 5 mini blots

PER.C6 cell line HCP ELISA Kit F530 Host cell protein assay, 96 tests

Pichia pastoris HCP ELISA Kit F140 Host cell protein assay, 96 tests

P.pastoris HCP Western Blot Kit F145 Host cell protein assay, 5 mini blots

Pichia pastoris HCP ELISA Kit, 2nd Generation F640 Antibodies to glycosylation epitopes have been removed and is much more specific than the F140.

Protein A ELISA Kit F050 Bioprocess contaminant assay, 96 tests

Protein A ELISA for human IgG F050H Bioprocess contaminant assay, 96 tests

Protein A ELISA kit F400 Bioprocess contaminant assay, 96 tests

Ps. fluorescens HCP ELISA kit F450 Host cell protein assay, 96 tests

S. cerevisiae HCP ELISA Kit F135 Host cell protein assay, 96 tests

S. cerevisiae HCP Western Blot Kit F130 Western Blot assay, 5 mini blots

SP 2/0 HCP ELISA Kit F180 Host cell protein assay, 96 tests

SP 2/0 HCP Western Blot Kit F185 Western Blot assay, 5 mini blots

S.aureus HCP ELISA Kit F320 Host cell protein assay, 96 tests

Ultra-Sensitive Insulin ELISA Kit F280 Bioprocess contaminant assay, 96 tests

Vero cell HCP ELISA kit F500 Host cell protein assay, 96 tests

Polyclonal Antisera

A549 HCP A549 Goat, neat serum

A549 HCP A549-PA Goat, IgG fraction

A549 HCP A549-AF Goat, affinity purified

Bovine Plasma Proteins BPP04 Rabbit, neat serum

Bovine Plasma Proteins BPP04-PA Rabbit, IgG fraction

Bovine Plasma Proteins BPP04-AF Rabbit, affinity purified

BHK HCP BHK1107 Goat, neat serum

BHK HCP BHK1107-PA Goat, IgG fraction

BHK HCP BHK1107-AF Goat, affinity purified

Campylobacter species 9-25B-PA Rabbit, IgG fraction

Campylobacter species 9-61A Guinea Pig, neat serum

Chlamydia species 8-29A Rabbit, neat serum

Chlamydia species 8-29A-PA Rabbit, IgG fraction

Chlamydia species 8-48 Guinea Pig, neat serum

CHO HCP C0016 Goat, neat serum

CHO HCP C0016-PA Goat, IgG fraction

CHO HCP C0016-AF Goat, affinity purified

CHO-CM HCP M0016 Goat, neat serum

CHO-CM HCP M0016-PA Goat, IgG fraction

CHO-CM HCP M0016-AF Goat, affinity purified

CHO HCP 3G 3G-0016 Goat, neat serum

CHO HCP 3G 3G-0016PA Goat, IgG fraction

CHO HCP 3G 3G-0016AF Goat, affinity purified

Cytomegalovirus 8-21B Rabbit, neat serum

Cytomegalovirus 8-53A Guinea Pig, neat serum

E. coli HCP F117 Goat, neat serum

E. coli HCP F117-PA Goat, IgG fraction

E. coli HCP AP117 Goat, affinity purified

Haemophilus influenzae 8-21A Rabbit, neat serum

Haemophilus influenzae 8-21A-PA Rabbit, IgG fraction

Haemophilus influenzae 8-53B Guinea Pig, neat serum

Haemophilus influenzae 8-53B-PA Guinea Pig, IgG fraction

HEK 293 HCP HK293 Goat, neat serum

Herpes Simplex Virus 8-25A Rabbit, neat serum

Herpes Simplex Virus 8-25A-PA Rabbit, IgG fraction

Herpes Simplex Virus 8-40B Guinea Pig, neat serum

Klebsiella pneumoniae, Genus 9-01 Rabbit, neat serum

Lactococcus lactic HCP LL5557 Goat, neat serum

Lactococcus lactic HCP LL5557-PA Goat, IgG fraction

Lactococcus lactic HCP LL5557-AF Goat, affinity purified

MRC5 HCP MRC5 Goat, neat serum

MRC5 HCP MRC5-PA Goat, IgG fraction

MRC5 HCP MRC5-AF Goat, affinity purified

Mycobacterium genus 8-27B Rabbit, neat serum

Mycobacterium genus 1-04-PA Guinea Pig, IgG fraction

Neisseria meningitidis 8-24B Rabbit, neat serum

Neisseria meningitidis 8-36 Guinea Pig, neat serum

NS/0 HCP N9192 Goat, neat serum

NS/0 HCP N9192-PA Goat, IgG fraction

NS/0 HCP N9192-AF Goat, affinity purified

PER.C6 cell line HCP PC118 Goat, neat serum

PER.C6 cell line HCP PC118-PG Goat, IgG fraction

PER.C6 cell line HCP PC118-AF Goat, affinity purified

Pichia pastoris HCP PI-49 Goat, neat serum

Pichia pastoris HCP PI-49PA Goat, IgG fraction

Pichia pastoris HCP PI-49AF Goat, affinity purified

Pichia pastoris HCP PI-49AF-B Goat, affinity purified-biotinylated

Pichia pastoris HCP PI-49AF-AP Goat, affinity purified-alk. phosphatase

Pseudomonas fluorescens 7-04 Goat, neat serum

Pseudomonas fluorescens 7-04PA Goat, IgG fraction

Pseudomonas fluorescens 7-04AF Goat, affinity purified

Pseudomonas species 8-57 Guinea Pig, neat serum

Saccharomyces cerevisiae HCP 82-SC Goat, neat serum

Saccharomyces cerevisiae HCP 82SC-PA Goat, IgG fraction

Saccharomyces cerevisiae HCP 82SC-AF Goat, affinity purified

Shigella species 9-03-PA Rabbit, IgG fraction

Shigella species 9-04 Rabbit, neat serum

SF9 HCP 12-SF9 Rabbit, neat serum

SF9 HCP 12-SF9-PA Rabbit, IgG fraction

SF21 HCP 34-SF21 Rabbit, neat serum

SF21 HCP 34-SF21-PA Rabbit, IgG fraction

SP2/0 HCP SP110 Goat, neat serum

SP2/0 HCP SP110-PA Goat, IgG fraction

SP2/0 HCP SP110-AF Goat, affinity purified

SP2/0 HCP SP110AF-B Goat, affinity purified-biotinylated

SP2/0 HCP SP110AF-AP Goat, affinity purified-alk. phosphatase

S. aureus HCP SA8114 Goat, neat serum

S. aureus HCP SA8114-AF Goat, affinity purified

Streptococcus pneumoniae 8-31B Rabbit, neat serum

Streptococcus pneumoniae 8-42A Guinea Pig, neat serum

Streptococcus pneumoniae 8-43A-PA Guinea Pig, IgG fraction

Total Goat Milk Proteins 4042 Rabbit, neat serum

Total Goat Milk Proteins 4042-PA Rabbit, IgG fraction

Total Goat Milk Proteins 4042-AF Rabbit, affinity purified

Vero cell HCP VC807 Goat, neat serum

Vero cell HCP VC807-PA Goat, IgG fraction

Vero cell HCP VC807-AF Goat, affinity purified

Stab-ELISA-rÔ Enzyme Conjugate Diluent/Stabilizers

Alkaline Phosphatase I-045 500mL

Alkaline Phosphatase I-040 1000mL

Alk Phos w/ HAMA blocker I-045H 500mL

Alk Phos w/ HAMA blocker I-040H 1000mL

Horseradish Peroxidase I-035 500mL

Horseradish Peroxidase I-030 1000mL

HRP w/ HAMA blocker I-035H 500mL

HRP w/ HAMA blocker I-030H 1000mL

Liquid Substrates

PNPP Liquid Substrate F008 For use with Alk Phos in ELISA, 100mL

PNPP Liquid Substrate F10008 For use with Alk Phos in ELISA, 1L

TMB Liquid Substrate F027 For use with HRP in ELISA, 100mL

TMB Liquid Substrate F100027 For use with HRP in ELISA, 1L

TMB Liquid Substrate F129 For use with HRP in Western Blot, 100mL

TMB Liquid Substrate F100029 For use with HRP in Western Blot, 1L

BCIP/NBT Liquid Substrate F064 For use with Alk Phos in WB, 1 reagent, 100mL

BCIP/NBT Liquid Substrate F00064 For use with Alk Phos in WB, 1 reagent, 1L

Sample Dilution Buffers

Sample Dilution Buffer, 1L， 100mL, 500mL I028 I028-100 I028-500 For use with BHK, E.coli, CHO, CHO-CM, Human IgG's, HSA, hTransferrin, HEK 293, Insulin, L.lactic, Mouse IgG's, Pichia pastoris, S.cerevisiae, Protein A, Vero cell ELISA kits

A549 Sample Diluent, 100mL , 500mL F233A-100 F233A-500 For use with A549 HCP ELISA kit

BSA Sample Dilution Buffer, 1L , 100mL , 500mL F031A / F031A-100 / F031A-500 For use with BSA, Bovine IgG, Bovine Plasma Proteins and Bovine Transferrin ELISA kits

Goat IgG Dilution Buffer, 1L , 100mL , 500mL F213A /F213A-100 / F213A-500 For use with Goat IgG ELISA kit

Goat Milk Diluent Buffer, 1L , 100mL r, 500mL F243A /F243A-100 /F243A-500 For use with Goat Milk Proteins ELISA kit

NS/0 Sample Dilution Buffer, 1L ，100mL ，500mL F223A / F223A-100 /F223A-500 For use with NS/0 HCP ELISA kit

SP2/0 Sample Dilution Buffer, 1L , 100mL , 500mL F183A / F183A-100 / F183A-500 For use with SP2/0 HCP ELISA kit

Immunogenicity Products

Passive Coated Immunogenicity Kit IM10 Kit for immunogenicity testing

Biotinylated Antigen Coated Immunogenicity Kit IM20 Kit for immunogenicity testing

Biotinylation Kit IM30

Human Immunoglobulin Screening Kit IM40 Kit for immunogenicity testing

Human IgG Subclass Kit IM50 Kit for immunogenicity testing

Substrate Kit IM109 TMB & Stop Solution for ELISA, 50mL

Coating Buffer, 1L IM101 For immunogenicity testing

Conjugate Diluent, 1L IM103 For immunogenicity testing

Conjugate Diluent, 500mL IM103-500 For immunogenicity testing

Sample Diluent, 500mL IM104 For immunogenicity testing

FG Blocker, 1L IM107 For immunogenicity testing

BSA Antigen, 1mg/mL IM112 For immunogenicity testing

Bovine IgG Antigen, 1mg/mL IM113 For immunogenicity testing

Bovine Transferrin Antigen, 1mg/mL IM114 For immunogenicity testing

CHO HCP Antigen, 1mg/mL IM115 For immunogenicity testing

E. coli HCP Antigen, 1mg/mL IM116 For immunogenicity testing

Goat IgG Antigen, 1mg/mL IM117 For immunogenicity testing

HSA Antigen, 1mg/mL IM118 For immunogenicity testing

Human IgD Antigen, 1mg/mL IM141 For immunogenicity testing

Human Transferrin Antigen, 1mg/mL IM119 For immunogenicity testing

Insulin Antigen, 1mg/mL IM121 For immunogenicity testing

Mouse IgG Antigen, 1mg/mL IM122 For immunogenicity testing

NS/0 HCP Antigen, 1mg/mL IM123 For immunogenicity testing

SP2/0 HCP Antigen, 1mg/mL IM125 For immunogenicity testing

Gyros Kits-discontinued

CHO 3G HCP G550 For use on the Gyros xP workstation, 560 tests

CHO 3G HCP G550-1 For use on the Gyros xP workstation, 112 tests

E.coli HCP G410 For use on the Gyros xP workstation, 560 tests

E.coli HCP G410-1 For use on the Gyros xP workstation, 112 tests

Protein A G400 For use on the Gyros xP workstation, 560 tests

Protein A G400-1 For use on the Gyros xP workstation, 112 tests

DNA Kits

DNA Extracton in Wells D100W 96 tests in a deep well microtiter plate

DNA Extraction in Tubes D100T 50 tests in microfuge tubes

Residual CHO Host Cell kit in Wells D550W 96 tests in a deep well microtiter plate

Residual CHO Host Cell kit in Tubes D550T 50 tests in microfuge tubes

CHO Amplification kit in Wells D555W 96 tests in a deep well microtiter plate

CHO Amplification kit in Tubes D555T 50 tests in microfuge tubes

Residual Ecoli Host Cell kit in Wells D410W 96 tests in a deep well microtiter plate

Residual Ecoli Host Cell kit in Tubes D410T 50 tests in microfuge tubes

E.coli Amplification kit in Wells D415W 96 tests in a deep well microtiter plate

E.coli Amplification kit in Tubes D415T 50 tests in microfuge tubes

Residual NS/0 Host Cell kit in Wells D220W 96 tests in a deep well microtiter plate

Residual NS/0 Host Cell kit in Tubes D220T 50 tests in microfuge tubes

Miscellaneous Reagents & Components

Deep Well Extraction Plate w/Sealing Mat D102 5 plates

DNA Extraction Buffer for use in tubes D108 30mL

DNA Extraction Buffer for use in wells D105 30mL

DNA Sample Diluent D006-100 100mL

DNA Sample Diluent D006-500 500mL

DNA Sample Diluent D006-1000 1L

DNA TE Buffer, 1L D001 1L

CHO DNA Concentrate D552 10ug/mL, 1mL

E.coli DNA Concentrate D412 10ug/mL, 1mL

NS/0 DNA Concentrate D222 10ug/mL, 1mL

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