GENTAUR

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Assays for Bioprocess Contaminant Testing

A. ELISA kits for Detection of Host Cell Proteins

1. CHO Host Cell Protein ELISA Kit – Cat. No: 28-F015
96 tests
Intended for the ultra-sensitive detection of the majority of CHO HCPs. As such, this kit can be used for
both process development as well as lot-to-lot release testing. The lower limit of detection for this assay is
approximately 400pg/mL or almost 100 times more sensitive than typical Western Blot methods.

2. CHO Protein Free Media ELISA Kit – Cat. No: 28-CM015
96 tests
Intended for use on pharmaceutical products secreted into protein free CHO growth media. This assay
utilizes HRP as the detection enzyme with an ultra-sensitive TMB substrate for rapid and highly sensitive
detection of a slightly more limited array of HCPs than those found in assays using antibodies generated
to cell lysates.

3. E.coli Host Cell Protein ELISA Kit– Cat. No: 28-F010
96 tests
Designed for measurement of E. coli host cell contaminants in recombinantly expressed products. The
colorimetric result can be read on conventional microtiter plate readers to a sensitivity of 250pg/mL of E.
coli total host cell protein equivalents.

4. HEK 293 HCP ELISA Kit – Cat. No: 28-F150
96 tests
Intended for measuring Human Embryonic Kidney 293 host cell protein contamination. The lowest
limit of detection for this assay is less than 300pg/mL. Precision of duplicate samples yields
average %CV’s of <7%.

5. Insect Cell Host Cell Protein SF9 & SF21 ELISA Kit
96 tests
Cat. No: 28-F020 for SF9
Cat. No: 28-F021 for SF21
Intended for measuring host cell proteins from Insect Cells, SF9 & SF21. Sensitivity of these assays are
~250pg/mL. Precision of duplicate samples yields average %CV’s of <7%.

6. Pichia pastoris HCP ELISA Kit – Cat. No: 28-F140
96 tests
Intended for measuring Pichia pastoris host cell protein contamination. Sensitivity of this assay is less than
300pg/mL. Precision of duplicate samples yields average %CV’s of <5%.
A. ELISA kits for Detection of Host Cell Proteins

7. Saccharomyces cerevisiae HCP ELISA Kit –Cat. No: 28-F135
96 tests
Intended for measuring host cell proteins from S. cerevisiae. Sensitivity of this assay is 400pg/mL and can be
improved upon by extending various incubation times or increasing sample size. Precision of duplicate samples
yields average %CV’s of <7%.

8. SP2/0 HCP ELISA Kit –Cat. No: 28-F180
96 tests
Intended for quantifying host cell proteins from hybridoma cell line SP2/0. Sensitivity of this assay is
~1ng/mL and can be improved upon by extending various incubation times or increasing sample size.
Precision of duplicate samples yields average %CV’s of <5%.

B. Western Blot Kits for Detection of Host Cell Proteins

1. CHO HCP Western Blot Kit(generic) – Cat. No: 28-F060
5 mini-gel blots/kit
Intended for detection of host cell proteins from Chinese Hamster Ovary cell recombinant expression
systems.

3. CHO Protein Free Media HCP Western Blot Kit – Cat. No: 28-CM060
5 mini-gel blots/kit
Intended for detection of host cell CHO HCPs typically secreted into protein free conditioned CHO
media.

4. E. coli HCP Western Blot Kit – Cat. No: 28-F025
5 mini-gel blots/kit
Intended for the detection of E. coli host cell contaminants in recombinantly expressed products. This
antibody is directly labeled with alkaline phosphatase to reduce time and labor while improving
specificity.

2. HEK 293 HCP Western Blot Kit – Cat. No: 28-F155
5 mini-gel blots/kit
Intended for the detection of HEK 293 host cell contaminants in recombinantly expressed products. These
antibodies have been shown to react to more than 40 different HEK 293 protein bands from SDS/DTT
solubilized HEK 293 cells. This kit provides a simple, yet sensitive system capable of detecting a little as
1ng of protein per band.

C. ELISA Kits for Detection of Bioprocess Contaminants

1. Bovine Serum Albumin (BSA) ELISA Kit – Cat. No: 28-F030
96 tests
This is a very sensitive assay for BSA, with a limit of detection of <250pg/mL. No interference from human,
sheep or rabbit albumin has been demonstrated at a 1mg/mL concentration. Precision of duplicate samples yields
average %CV’s of <7% for samples greater than the lowest standard.

2. Bovine IgG ELISA Kit – Cat. No: 28-F070
96 tests
Intended to quantitate bovine IgG contamination in various types of samples throughout the purification
process. The colorimetric endpoint can be read within three hours on a conventional microtiter plate reader to
a sensitivity of <250pg/mL of bovine IgG.

3. Bovine Transferrin ELISA Kit – Cat. No: 28-F120
96 tests
Intended to quantitation of Bovine Transferrin in various types of samples. Precision of duplicate samples
yields average %CV’s of <7% for samples greater than the lowest standard. The limit of detection is less
than 200pg/mL.

4. HAMA/Heterophilic Antibody ELISA Kit – Cat. No: 28-F085
96 tests
Intended for use in determining the presence and semi-quantitation of human anti-mouse antibodies, and other
human heterophilic antibodies against rabbit, goat and sheep immunoglobulins. The kit can be used as a quality
control aid for diagnostic assays to determine if potentially interfering heterophilic antibodies are present. The
kit can also be used to monitor patients receiving mouse monoclonal therapeutic or imaging agents to determine
if these agents are eliciting an immune response.

5. Human Immunoglobulin A ELISA Kit – Cat. No: 28-F165
96 tests
Intended for the sensitive and specific detection and quantitation of human immunoglobulin A. This kit is
specific for hIgA and thus can be used to quantitate IgA in the presence of hIgG and hIgM.

6. Human Immunoglobulin M ELISA Kit – Cat. No: 28-F170
96 tests
Intended for the sensitive and specific detection and quantitation of human immunoglobulin M. This kit is
specific for hIgM and thus can be used to quantitate IgM in the presence of hIgG and hIgA.

7. Human Total Immunoglobulin G ELISA Kit – Cat. No: 28-F160
96 tests
Intended for the sensitive and specific detection and quantitation of total human immunoglobulins. This assay is
useful in detecting trace contamination by hIgG in a variety of sample types.

8. Human Serum Albumin ELISA Kit – Cat. No: 28-F055
96 tests
The colorimetric endpoint can bed read on a conventional microtiter reader to a sensitivity of
<200pg/mL of albumin. Precision of duplicate samples yields average %CV’s of <7% for samples greater than
the lowest standard.

9. Human Transferrin ELISA Kit – Cat. No: 28-F035
96 tests
The colorimetric endpoint can bed read on a conventional microtiter reader to a sensitivity of
100pg/mL of human transferrin.

10. Mouse Immunoglobulin Subclass ELISA Kits for IgG1, IgG2a, IgG2b, IgA, IgM and Total IgG
96 tests
IgA : Cat. No: 28-F095
IgG1 : Cat. No: 28-F045
IgG2a : Cat. No: 28-F046
IgG2b : Cat. No: 28-F047
IgM : Cat. No: 28-F090
IgG : Cat. No: 28-F049
These kits are intended to quantify specific mouse IgG subclasses from various types of samples. They can be
used to measure a mouse immunoglobulin subclass which may leach off an affinity support during elution of the
desired product. Kits can also be used to quantitate mouse immunoglobulin levels in serum of other animals
administered mouse monoclonal antibodies in research studies.

11. Insulin ELISA Kit – Cat. No: 28-F040
96 tests
The antibodies in this kit cross react 100% with insulin from human, bovine and porcine. The colorimetric
endpoint can bed read on a conventional microtiter reader to a sensitivity of 250pg/mL of albumin. Precision of
duplicate samples yields average %CV’s of <7% for samples greater than the lowest standard.

12. Protein A ELISA Kit
96 tests
Cat. No: 28-F050
This kit is intended for the quantitation of Protein A in various types of samples and can be used to measure
Protein A that leaches off of affinity supports during the purification of immunoglobulins. Endogenous
immunoglobulin present in the sample and bound to Protein A through its Fc region can usually interfere in most
immunoassays. This kit is recommended for applications in which the samples may contain mouse
immunoglobumin or humanized or chimeric antibodies.

13. Protein A-h ELISA Kits
96 tests
Cat. No: 28-F050H
Protein A-h ELISA kit is best for use in detecting samples containing natural forms of human IgG, or those that
have been shown to be significantly inhibitory to the binding of anti-Protein A antibodies. Most product antibody
inhibition is eliminated through the use of a validated sample pretreatment step.

14. Protein G ELISA Kit
96 tests
Cat. No: 28-F110
This assay is designed to minimize the interference from endogenous immunoglobulins present in the sample
and bound to Protein G through its Fc region. The kit can detect Protein G contamination of <250pg/mL in the
presence of up to 10mg/mL of mouse IgG.

D. Polyclonal Antisera to Bioprocess Contaminants

Chinese Hamster Ovary(CHO) HCP from cell lysates
Suggested application: For Western Blot, or ELISA to detect contamination of CHO host cell proteins in
recombinantly manufactured products.

Chinese Hamster Ovary(CHO) HCP from protein free media
Suggested application: For Western Blot, or ELISA to detect contamination of CHO host cell proteins from
protein free media.

Escherichia coli HCP
Suggested application: For Western Blot, dot blos, or ELISA assays to detect E. coli host cell protein
contamination in recombinantly manufactured products.

HEK 293 Host Cell Proteins
Suggested application: For Western Blot, or ELISA assays to detect contamination of HEK 293 HCP
in recombinantly manufactured products.

Pichia pastoris HCP
Suggested application: For Western Blot, or ELISA assays to detect contamination of Pichia pastoris
HCP in recombinantly manufactured products.

Protein G
Suggested application: For Western Blot, dot blot, or ELISA assays.

Saccharomyces cerevisiae Host Cell Proteins
Suggested application: For Western Blot and ELISA to detect contamination of S. cerevisiae HCP.

SF9 Host Cell Proteins
Suggested application: For Western Blot and ELISA.

 
SF21 Host Cell Proteins
Suggested application: For Western Blot and ELISA.

SF21 Host Cell Proteins
Suggested application: For Western Blot and ELISA to detect contamination of SP 2/0 HCP in
recombinantly manufactured antibody products.

E. Polyclonal Antisera to Microbial Agents

Campylobacter species
Suggested application: For ELISA and latex agglutination.

Chlamydia species
Suggested applications include direct antigen detection, ELISA, or fluorescent antibody techniques.

Cytomegalovirus (CMV)
Suggested applications include ELISA, fluorescent antibody and other microscopy techniques.

Haemophilus influenzae
Suggested applications include latex agglutination or sandwich ELISA.

Herpes Simplex Virus
Suggested applications include ELISA, A techniques, and virus neutralization.

Klebsiella pneumoniae, genus
Suggested applications include ELISA and latex agglutination.

Mycobacterium genus
Suggested applications include ELISA antibodies for direct detection of the antigen.

Neisseria meningitidis
Suggested applications include ELISA and latex agglutination.

Pseudomonas
Suggested applications include ELISA and latex agglutination.

Shigella species
Suggested applications include ELISA and latex agglutination.

Streptococcus pneumoniae
Suggested applications include ELISA and latex agglutination.