Ligand Binding Assays – ELISA

Ligand Binding Assays – ELISA
PHARMACOKINETIC ASSAYS

For pharmacokinetic study of mAbs, FDA and EMA have issued specific guidance for the validation of
pharmacokinetic methods that require full method validation for assays that are used to measure
monoclonal antibody concentrations in biological matrices at both preclinical and clinical phases.
Krishgen Biosystem’s collection comprises a number for mAbs ELISA kit for pharmacokinetic studies to
meet the regulatory requirements.

Ligand Binding Assays - ELISA
Ligand Binding Assays – ELISA

KRIBIOLISA Gentaur Elisa Kits are a dedicated range designed to detect and quantify biosimilar antibodies in human
serum and plasma using the sandwich ELISA method.

Cat No Product Particulars Pack Size

  1. KBI1010 KRIBIOLISA™ Rituximab (RITUXAN) ELISA ELISA 96 wells
  2. KBI1011 KRIBIOLISA™ Infliximab (REMICADE) ELISA ELISA 96 wells
  3. KBI1012 KRIBIOLISA™ Alemtuzumab (LEMTRADA) ELISA ELISA 96 wells
  4. KBI1013 KRIBIOLISA™ Etanercept (ENBREL) ELISA ELISA 96 wells
  5. KBI1014 KRIBIOLISA™ Ustekinumab (STELARA) ELISA ELISA 96 wells
  6. KBI1015 KRIBIOLISA™ Adalimumab ELISA ELISA 96 wells
  7. KBI1016 KRIBIOLISA™ Bevacizumab (AVASTIN) ELISA ELISA 96 wells
  8. KBI1017 KRIBIOLISA™ Trastuzumab (HERCEPTIN) ELISA ELISA 96 wells
  9. KBI1018 KRIBIOLISA™ Cetuximab (ERBITUX) ELISA ELISA 96 wells
  10. KBI1019 KRIBIOLISA™ Golimumab (SIMPONI) ELISA ELISA 96 wells
  11. KBI1020 KRIBIOLISA™ Natalizumab (TYSABRI) ELISA ELISA 96 wells
  12. KBI1021 KRIBIOLISA™ Omalizumab (XOLAIR) ELISA ELISA 96 wells
  13. KBI1022 KRIBIOLISA™ Tocilizumab (ACTEMRA) ELISA ELISA 96 wells
  14. KBI1024 KRIBIOLISA™ Eculizumab (SOLIRIS) ELISA ELISA 96 wells
  15. KBI1025 KRIBIOLISA™ Ipilimumab (YERVOY) ELISA ELISA 96 wells
  16. KBI1026 KRIBIOLISA™ Denosumab (PROLIA) ELISA ELISA 96 wells
  17. KBI1027 KRIBIOLISA™ Atezolizumab (TECENTRIQ) ELISA ELISA 96 wells
  18. KBI1028 KRIBIOLISA™ Daratumumab (DARZALEX) ELISA ELISA 96 wells
  19. KBI1029 KRIBIOLISA™ Ranibizumab (Lucentis) ELISA ELISA 96 wells

Key Benefits of KRIBIOLISA

  1.  CE Marked Kits.
  2.  Standards Calibrated Against Reference Innovator Biopharmaceutical
  3.  Validated as per ICH/FDA Guidelines for Bioassays
  4.  Ready-To-Use, with break apart 96 well tray; includes positive control
  5.  High Specificity and High Sensitivity

Ligand Binding Assays – ELISA
ADA / IMMUNOGENICITY ASSAYS

Gentaurs supplier KRISHGEN has focused to develop ready-to-use Immunogenicity ELISA Kits, specially designed for detecting high affinity anti-antibody drug antibodies (ADAs) and other targets.
The importance of immunogenicity data is reinforced by the FDA’s regulations stating that “the goal of the immunogenicity assessment is to evaluate potential differences between the proposed product and the originator / reference product in the incidence and severity of human immune responses .

 

Thus establishing that there are no clinically
meaningful differences in immune response between a proposed product and the reference product is a key element
in the demonstration of biosimilarity.”

The European Medicines Agency (EMA) regulations provide a similar focus, noting that “immunogenicity testing of the
biosimilar and the reference products should be conducted within the comparability exercise by using the same assay
format and sampling schedule. Assays should be performed with both the reference and biosimilar molecule in parallel (in a blinded fashion) to measure the immune response against the product that was received by each patient.”

Therefore, it is critical to collect, evaluate, and compare the safety and immunogenicity data from clinical
pharmacology studies used in biosimilar development. Such data becomes even more critical when the
originator or reference product is known to have the potential for immune-mediated toxicity.
This highlights the importance of using Immunogenicity kits which are well validated, well
characterized and sensitive and specific.

Cat No Product Particulars Pack Size

  1. KBI2010 KRIBIOLISA™ Anti-Rituximab (RITUXAN) ELISA ELISA 96 wells
  2. KBI2010r KRIBIOLISA™ Anti-Rituximab (RITUXAN) ELISA
  3. (for rat species) ELISA 96 wells
  4. KBI2011 KRIBIOLISA™ Anti-Infliximab (REMICADE) ELISA ELISA 96 wells
  5. KBI2012 KRIBIOLISA™ Anti-Alemtuzumab (LEMTRADA) ELISA ELISA 96 wells
  6. KBI2013 KRIBIOLISA™ Anti-Etanercept (ENBREL) ELISA ELISA 96 wells
  7. KBI2014 KRIBIOLISA™ Anti-Ustekinumab (STELARA) ELISA ELISA 96 wells
  8. KBI2015 KRIBIOLISA™ Anti-Adalimumab ELISA ELISA 96 wells
  9. KBI2016 KRIBIOLISA™ Anti-Bevacizumab (AVASTIN) ELISA ELISA 96 wells
  10. KBI2017 KRIBIOLISA™ Anti-Trastuzumab (HERCEPTIN) ELISA ELISA 96 wells
  11. KBI2018 KRIBIOLISA™ Anti-Cetuximab (ERBITUX) ELISA ELISA 96 wells
  12. KBI2019 KRIBIOLISA™ Anti-Golimumab (SIMPONI) ELISA ELISA 96 wells
  13. KBI2020 KRIBIOLISA™ Anti-Natalizumab (TYSABRI) ELISA ELISA 96 wells
  14. KBI2021 KRIBIOLISA™ Anti-Omalizumab (XOLAIR) ELISA ELISA 96 wells
  15. KBI2022 KRIBIOLISA™ Anti-Tocilizumab (ACTEMRA) ELISA ELISA 96 wells
  16. KBI2024 KRIBIOLISA™ Anti Eculizumab (SOLIRIS) ELISA ELISA 96 wells
  17. KBI2025 KRIBIOLISA™ Anti-Ipilimumab (YERVOY) ELISA ELISA 96 wells
  18. KBI2026 KRIBIOLISA™ Anti-Denosumab (PROLIA) ELISA ELISA 96 wells

Ligand Binding Assays – ELISA
ADA / IMMUNOGENICITY ASSAYS

Cat No Product Particulars Pack Size

  1. KBI2027 KRIBIOLISA™ Anti-Atezolizumab (TECENTRIQ) ELISA ELISA 96 wells
  2. KBI2028 KRIBIOLISA™ Anti-Daratumumab (DARZALEX) ELISA ELISA 96 wells
  3. KBI2029 KRIBIOLISA™ Anti-Ranibizumab (Lucentis) ELISA ELISA 96 wells
  4. KBI2029r KRIBIOLISA™ Rat Anti-Ranibizumab (Lucentis) ELISA ELISA 96 wells
  5. KBI6200 KRIBIOLISA™ Anti-EPO (Erythropoetin) ELISA ELISA 96 wells
  6. KBI7067 KRIBIOLISA™ Antibodies to (S.Typhi) Typhoid Vi IgM ELISA ELISA 96 wells
  7. KBI7800 KRIBIOLISA™ Anti-AAV5 ELISA ELISA 96 wells
  8. KBI8000 KRIBIOLISA™ Anti-Human PTH (1-34) Antibody ELISA ELISA 96 wells
  9. Key Benefits of KRIBIOLISATM:

 CE Marked Kits.
 Standards Calibrated Against Reference Innovator Biopharmaceutical
 Validated as per ICH/FDA Guidelines for Bioassays
 Ready-To-Use, with break apart 96 well tray; includes positive control
 High Specificity and High Sensitivity

KRIBIOLISA ELISAs follow the sandwich principle –
with a straightforward procedure and ready to use plates.

Ligand Binding Assays – ELISA
RESIDUAL ASSAYS

Cat No Product Particulars Pack Size

  1. KRA1001 KRIBIOLISA™ Streptomycin ELISA ELISA 96 wells
  2. KRA1002 KRIBIOLISA™ Ampicillin ELISA ELISA 96 wells
  3. KRA1003 KRIBIOLISA™ Erythromycin ELISA ELISA 96 wells
  4. KRA1004 KRIBIOLISA™ Kanamycin ELISA ELISA 96 wells
  5. KRA1005 KRIBIOLISA™ Penicillin ELISA ELISA 96 wells
  6. KRA1006 KRIBIOLISA™ Tetracycline ELISA ELISA 96 wells
  7. KRA1007 KRIBIOLISA™ Tylosin ELISA ELISA 96 wells
  8. KRA1008 KRIBIOLISA™ Colimycin ELISA ELISA 96 wells
  9. KRA1009 KRIBIOLISA™ Gentamicin ELISA ELISA 96 wells
  10. KRA1010 KRIBIOLISA™ Neomycin ELISA ELISA 96 wells
  11. KBI1001 KRIBIOLISA™ Human IgG ELISA ELISA 96 wells
  12. KBI1001-10 KRIBIOLISA™ Human IgG ELISA ELISA 10 x 96 wells
  13. KBI1002 KRIBIOLISA™ Human IgG Isotyping ELISA ELISA 96 wells
  14. KBI1003 KRIBIOLISA™ Mouse IgG ELISA ELISA 96 wells
  15. KBI1004 KRIBIOLISA™ Mouse IgG Isotyping ELISA (12 tests) ELISA 8 x 12 wells
  16. KBI1005 KRIBIOLISA™ Rat IgG ELISA ELISA 96 wells
  17. KBI1005-10 KRIBIOLISA™ Rat IgG ELISA ELISA 10 x 96 wells
  18. KBI1006 KRIBIOLISA™ Bovine IgG ELISA ELISA 96 wells
  19. KBI1007 KRIBIOLISA™ Human IgG4 ELISA 96 wells
  20. KBI1101 KRIBIOLISA™ Human IgE ELISA ELISA 96 wells
  21. KBI1103 KRIBIOLISA™ Mouse IgE ELISA ELISA 96 wells

BIOPROCESS CONTAMINATION ASSAYS

Biopharmaceuticals such as therapeutic antibodies and recombinant proteins are produced in genetically
engineered host cells. Effective removal of host cell contaminants from the production cell lines is required
by regulatory agencies to ensure product safety. In general, levels up to 10 ng residual host cell DNA per
dose, depending on the host cell type and the route of administration, and 100 ppm for residual host cell
protein are acceptable.

Considering biopharmaceuticals development, we now offer kits for complete biological assays as per
guidelines.

KBBP01 KRIBIOLISA™ E.coli HCP ELISA ELISA 96 wells
KBBP02 KRIBIOLISA™ Pichia Pastoris HCP ELISA ELISA 96 wells
KBBP03 KRIBIOLISA™ CHO HCP ELISA ELISA 96 wells

Ligand Binding Assays – ELISA
BIOPROCESS CONTAMINATION ASSAYS

Cat No Product Particulars Pack Size
KBBP05 KRIBIOLISA™ SP 2/0 HCP ELISA ELISA 96 wells
KBBP06 KRIBIOLISA™ Ovalbumin ELISA ELISA 96 wells
KBBP07 KRIBIOLISA™ Human Serum Albumin ELISA ELISA 96 wells
KBBP08 KRIBIOLISA™ Human IgG ELISA ELISA 96 wells
KBBP09 KRIBIOLISA™ Human IgA ELISA ELISA 96 wells
KBBP10 KRIBIOLISA™ Bovine Serum Albumin ELISA * ELISA 96 wells
KBBP11 KRIBIOLISA™ Protein A ELISA ELISA 96 wells
KBBP12 KRIBIOLISA™ Protein A ELISA (natural & structurally conserved recombinant Protein A specific) ELISA 96 wells
KBBR01 KRIBIOLISA™ E.coli Host Cell DNA Kit 100 reactions
KBBR02 KRIBIOLISA™ CHO Host Cell DNA Kit 100 reactions
KBBR03 KRIBIOLISA™ Insect Cell Host Cell DNA Kit 100 reactions
KBBA01 KRIBIOLISA™ EPO (Erythropoietin) ELISA ELISA 96 wells
KBBA02 KRIBIOLISA™ Anti G-CSF ELISA ELISA 96 wells
KBBA01r KRIBIOLISA™ EPO Alpha (Erythropoietin alpha) ELISA ELISA 96 wells

KRISHGEN BIOSYSTEMS

Competitive Ligand Binding Assays
NEUTRALISING ANTIBODY ASSAYS

Cat No Product Particulars Pack Size

KBI4010 KRIBIOLISA™ Anti-Rituximab (RITUXAN) Neutralizing Antibody (CLBA)
ELISA ELISA 96 wells
KBI4011 KRIBIOLISA™ Anti-Infliximab (REMICADE) Neutralizing Antibody (CLBA)
ELISA ELISA 96 wells
KBI4012 KRIBIOLISA™ Anti-Alemtuzumab (LEMTRADA) Neutralizing Antibody
(CLBA) ELISA ELISA 96 wells
KBI4013 KRIBIOLISA™ Anti-Etarnacept (ENBREL) Neutralizing Antibody (CLBA)
ELISA ELISA 96 wells
KBI4014 KRIBIOLISA™ Anti-Ustekinumab (STELARA) Neutralizing Antibody
(CLBA) ELISA ELISA 96 wells
KBI4015 KRIBIOLISA™ Anti-Adalimumab Neutralizing Antibody (CLBA) ELISA ELISA 96 wells
KBI4016 KRIBIOLISA™ Anti-Bevacuzimab (AVASTIN) Neutralizing Antibody
(CLBA) ELISA ELISA 96 wells
KBI4017 KRIBIOLISA™ Anti-Trastuzumab (HERCEPTIN) Neutralizing Antibody
(CLBA) ELISA ELISA 96 wells
KBI4018 KRIBIOLISA™ Anti-Cetuximab (ERBITUX) Neutralizing Antibody (CLBA)
ELISA ELISA 96 wells
KBI4019 KRIBIOLISA™ Anti-Golimumab (SIMPONI) Neutralizing Antibody (CLBA)
ELISA ELISA 96 wells
KBI4020 KRIBIOLISA™ Anti-Natalizumab (TYSABRI) Neutralizing Antibody
(CLBA) ELISA ELISA 96 wells
KBI4021 KRIBIOLISA™ Anti-Omalizumab (XOLAIR) Neutralizing Antibody (CLBA)
ELISA ELISA 96 wells
KBI4022 KRIBIOLISA™ Anti-Tocilizumab (ACTEMRA) Neutralizing Antibody
(CLBA) ELISA ELISA 96 wells
KBI4024 KRIBIOLISA™ Anti Eculizumab (SOLIRIS) Neutralizing Antibody (CLBA)
ELISA ELISA 96 wells
KBI4025 KRIBIOLISA™ Anti-Ipilimumab (YERVOY) Neutralizing Antibody (CLBA)
ELISA ELISA 96 wells
KBI4026 KRIBIOLISA™ Anti-Denosumab (PROLIA) Neutralizing Antibody (CLBA)
ELISA ELISA 96 wells
KBI4027 KRIBIOLISA™ Anti-Atezolizumab (TECENTRIQ) Neutralizing Antibody
(CLBA) ELISA ELISA 96 wells
KBI4028 KRIBIOLISA™ Anti-Daratumumab (DARZALEX) Neutralizing Antibody
(CLBA) ELISA ELISA 96 wells

C1Q PROTEINS AND BINDING ASSAYS
KRISHGEN BIOSYSTEMS

Cat No Product Particulars Pack Size

  1. KBI3000r KRIBIOLISA™ C1Q Protein 1 mg / vial
  2. KBI3010 KRIBIOLISA™ Rituximab (RITUXAN) C1Q Binding ELISA ELISA 4 x 96 wells
  3. KBI3011 KRIBIOLISA™ Infliximab (REMICADE) C1Q Binding ELISA ELISA 4 x 96 wells
  4. KBI3012 KRIBIOLISA™ Alemtuzumab (LEMTRADA) C1Q Binding ELISA ELISA 4 x 96 wells
  5. KBI3013 KRIBIOLISA™ Etarnacept (ENBREL) C1Q Binding ELISA ELISA 4 x 96 wells
  6. KBI3014 KRIBIOLISA™ Ustekinumab (STELARA) C1Q Binding ELISA ELISA 4 x 96 wells
  7. KBI3015 KRIBIOLISA™ Adalimumab (Humira) C1Q Binding ELISA ELISA 4 x 96 wells
  8. KBI3016 KRIBIOLISA™ Bevacuzimab (AVASTIN) C1Q Binding ELISA ELISA 4 x 96 wells
  9. KBI3017 KRIBIOLISA™ Trastuzumab (HERCEPTIN) C1Q Binding ELISA ELISA 4 x 96 wells
  10. KBI3018 KRIBIOLISA™ Cetuximab (ERBITUX) C1Q Binding ELISA ELISA 4 x 96 wells
  11. KBI3019 KRIBIOLISA™ Golimumab (SIMPONI) C1Q Binding ELISA ELISA 4 x 96 wells
  12. KBI3020 KRIBIOLISA™ Natalizumab (TYSABRI) C1Q Binding ELISA ELISA 4 x 96 wells
  13. KBI3021 KRIBIOLISA™ Omalizumab (XOLAIR) C1Q Binding ELISA ELISA 4 x 96 wells
  14. KBI3022 KRIBIOLISA™ Tocilizumab (ACTEMRA) C1Q Binding ELISA ELISA 4 x 96 wells
  15. KBI3024 KRIBIOLISA™ Eculizumab (SOLIRIS) C1Q Binding ELISA ELISA 4 x 96 wells

KBI3025 KRIBIOLISA™ Ipilimumab (YERVOY) C1Q Binding ELISA ELISA 4 x 96 wells

KBI3026 KRIBIOLISA™ Denosumab (PROLIA) C1Q Binding ELISA ELISA 4 x 96 wells

REPORTER ASSAYS
ADCC ASSAYS

Cat No Product Particulars Pack Size

KADC-001 Rituximab ADCC Assay
KADC-001-01 Rituximab ADCC Assay Target Cells (Raji)
KADC-001-02 ADCC Assay Effector Cells 5 million cells / 1 ml vial
KADC-002 Rituximab ADCC Assay
KADC-002-01 Rituximab ADCC Assay Target Cells (WIL2-S) 2 million cells / 1 ml vial
KADC-001-02 ADCC Assay Effector Cells 5 million cells / 1 ml vial
KADC-003 Trastuzumab ADCC Assay
KADC-003-01 Trastuzumab ADCC Assay Target Cells (BT-474) 2 million cells / 1 ml vial
KADC-001-02 ADCC Assay Effector Cells 5 million cells / 1 ml vial
KADC-004 Cetuximab ADCC Assay
KADC-004-01 Cetuximab ADCC Assay Target Cells (A431) 2 million cells / 1 ml vial
KADC-001-02 ADCC Assay Effector Cells 5 million cells / 1 ml vial
KADC-005 Bevacizumab ADCC Assay
KADC-005-01 Bevacizumab ADCC Assay Target Cells (HUVECs) 500,000 cells / 1 ml vial
KADC-001-02 ADCC Assay Effector Cells 5 million cells / 1 ml vial
KADC-006 Pertuzumab ADCC Assay
KADC-006-01 Pertuzumab ADCC Assay Target Cells (HUVECs) 500,000 cells / 1 ml vial
KADC-001-02 ADCC Assay Effector Cells 5 million cells / 1 ml vial
KADC-007 Atezolimumab ADCC Assay
KADC-007-01 Atezolimumab ADCC Assay Target Cells (PDL-1) 2 million cells / 1 ml vial
KADC-001-02 ADCC Assay Effector Cells 5 million cells / 1 ml vial

POTENCY / REPORTER ASSAYS
Recombinant FSH

RAC-FSH Reporter Assay Cells 5 million cells / vial
KRE-201A Recombinant FSH Reference Standard 100 ug
Recombinant LH
RAC-LH Reporter Assay Cells 5 million cells / vial
KRE-204A Recombinant LH Reference Standard 100 ug

REPORTER ASSAYS
POTENCY / REPORTER ASSAYS

Cat No Product Particulars Pack Size
Recombinant TSH
RAC-TSH Reporter Assay Cells 5 million cells / vial
KRE-203A Recombinant TSH Reference Standard 100 ug
Aflibercept
RAC-Afli Assay Cells (screened for Proliferation Assay) 5 million cells / vial
KRE-209A VEGF165 Reference Standard 100 ug
Ranibizumab
RAC-Rani Assay Cells (screened for Proliferation Assay) 5 million cells / vial
KRE-209A VEGF165 Reference Standard 100 ug
Bevacizumab
RAC-Beva Assay Cells (screened for Proliferation Assay) 5 million cells / vial
KRE-209A VEGF165 Reference Standard 100 ug
Pertuzumab
RAC-Pertu Assay Cells (screened for Proliferation Assay) 5 million cells / vial
KRE-209A VEGF165 Reference Standard 100 ug
Exenatide
RAC-Extena GLP-1R Assay Cells 5 million cells / vial
KRE-212A Anti-GLP1R Reference Standard 100 ug
ExtenaPC Exenatide Positive Control 100 ug
Liraglutide
RAC-GLP1R GLP-1R Assay Cells 5 million cells / vial
KRE-215A Anti-GLP1R Reference Standard 100 ug
LiraPC Liraglutide Positive Control 100 ug
Semaglutide
RAC-Sema GLP-1R Assay Cells 5 million cells / vial
KRE-215A Anti-GLP1R Reference Standard 100 ug
SemaPC Semaglutide Positive Control 100 ug
Albiglutide
RAC-Albi GLP-1R Assay Cells 5 million cells / vial
KRE-215A Anti-GLP1R Reference Standard 100 ug
AlbiPC Albiglutide Positive Control 100 ug
Dulaglutide
RAC-Dula GLP-1R Assay Cells 5 million cells / vial
KRE-215A Anti-GLP1R Reference Standard 100 ug
DulaPC Dulaglutide Positive Control 100 ug

ADCP ASSAYS

 

Cat No Product Particulars Pack Size
KADP-01 KRIBIOLISA™ ADCP Reporter Bioassay Complete Kit 1 kit
CELL ASSAYS
VIABILTY, PROLIFERATION, CYTOTOXICITY
CC1100 Kinetic Blue Assay 100 ml
CC2001 Penicillin / Streptomycin Solution 100 ml
CC5002 Titanium™ One-Step Luciferase Assay System 500 tests