Kribiolisa ELISA kits for drug monitoring of therapeutic drugs like Adalimumab, Trastuzumab, Atezolizumab, Eculizumab, Ranibizumab. Sensitive assays for drug monitoring and immunogenicity. CE marked.

1. ECULIZUMAB
T H E F O R E F R O N T O F B I O L O G I C S M O N I T O R I N G
KRIBIOLISA™
ASSAY KITS
KRIBIOLISA ECULIZUMAB ELISA
KRIBIOLISA ANTI-ECULIZUMAB ELISA
Marked Kits
DRUG ASSAYS
KRIBIOLISA™ Rituximab (RITUXAN®) ELISA
KRIBIOLISA™ Infliximab (REMICADE®) ELISA
KRIBIOLISA™ Alemtuzumab (LEMTRADA®) ELISA
KRIBIOLISA™ Etarnacept (ENBREL®) ELISA
KRIBIOLISA™ Ustekinumab (STELARA®) ELISA
KRIBIOLISA™ Adalimumab (HUMIRA®)ELISA
KRIBIOLISA™ Bevacuzimab (AVASTIN®)ELISA
KRIBIOLISA™ Trastuzumab (HERCEPTIN) ELISA
KRIBIOLISA™ Humanized Anti-Her2/neu (Herceptin/Trastuzumab) ELISA
KRIBIOLISA™ Cetuximab (ERBITUX®) ELISA
KRIBIOLISA™ Golimumab (SIMPONI®) ELISA
KRIBIOLISA™ Natalizumab (TYSABRI®) ELISA
KRIBIOLISA™ Omalizumab (XOLAIR®) ELISA
KRIBIOLISA™ Tocilizuma b (ACTEMRA®) ELISA
KRIBIOLISA™ Eculizumab (SOLIRIS®) ELISA
KRIBIOLISA™ Ipilimumab (YERVOY®) ELISA
KRIBIOLISA™ Denosumab (PROLIA®) ELISA
KRIBIOLISA™ Atezolizumab (TECENTRIQ®) ELISA
KRIBIOLISA™ Daratumumab (DARZALEX®) ELISA
KRIBIOLISA™ Ranibizumab (LUCENTIS®) ELISA
ANTI-DRUG ANTIBODY ASSAYS
KRIBIOLISA™ Anti-Rituximab (RITUXAN®) ELISA
KRIBIOLISA™ Anti-Infliximab (REMICADE®) ELISA
KRIBIOLISA™ Anti-Alemtuzumab (LEMTRADA®) ELISA
KRIBIOLISA™ Anti-Etarnacept (ENBREL®) ELISA
KRIBIOLISA™ Anti-Ustekinumab (STELARA®) ELISA
KRIBIOLISA™ Anti-Adalimumab (HUMIRA®)ELISA
KRIBIOLISA™ Anti-Bevacuzimab (AVASTIN®) ELISA
KRIBIOLISA™ Anti-Trastuzumab (HERCEPTIN®) ELISA
KRIBIOLISA™ Anti-Cetuximab (ERBITUX®) ELISA
KRIBIOLISA™ Anti-Golimumab (SIMPONI®) ELISA
KRIBIOLISA™ Anti-Natalizumab (TYSABRI®) ELISA
KRIBIOLISA™ Anti-Omalizumab (XOLAIR®) ELISA
KRIBIOLISA™ Anti-Tociliz umab (ACTEMRA®) ELISA
KRIBIOLISA™ Anti Eculizumab (SOLIRIS®) ELISA
KRIBIOLISA™ Anti-Ipilimumab (YERVOY®) ELISA
KRIBIOLISA™ Anti-Denosumab (PROLIA®) ELISA
KRIBIOLISA™ Anti-Atezolizumab (TECENTRIQ®) ELISA
KRIBIOLISA™ Anti-Daratumumab (DARZALEX®) ELISA
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2. O U R P H I L O S O P H Y I S T O D E L I V E R T H E B E S T A S S A Y A N D
T O O L S F O R Y O U R S C I E N C E .
ASSAY KIT PARTICULARS :
KRIBIOLISA™ ECULIZUMAB ELISA KRIBIOLISA™ ANTI-ECULIZUMAB ELISA
KIT CATALOG NUMBER: KBI1024 KIT CATALOG NUMBER: KBI2024
TYPE OF ASSAY: ELISA, SANDWICH BASED TYPE OF ASSAY: ELISA, SANDWICH BASED
SAMPLE MATRIX: SERUM, PLASMA, CELL CULTURE SAMPLE MATRIX: SERUM, PLASMA, CELL CULTURE
SUPERNATANT SUPERNATANT
CALIBRATOR RANGE: 0 -100 UG/ML CALIBRATOR RANGE: 0 - 640 NG/ML
REGULATORY STATUS: REGULATORY STATUS:
IN USA : FOR RESEARCH USE IN USA : FOR RESEARCH USE
IN EUROPE : CE MARKED, FOR IVD USE IN EUROPE : CE MARKED, FOR IVD USE
VALIDATION:
AS PER ICH AND FDA GUIDELINES FOR BIOLOGICAL ASSAYS
ECULIZUMAB -
COMPLEMENT C5 INHIBITOR
Drug Class: Monoclonal Antibod-
ies; Complement C5 inhibitor
Eculizumab, is a monoclonal anti-
body that binds to the complement
protein C5 specifically and with
high affinity, thereby inhibiting its
cleavage to C5a and C5b and sub-
sequent generation of the terminal
complement complex C5b-9. Solir-
is inhibits terminal complement
mediated intravascular hemolysis
in PNH patients and therefore the
destruction of PNH erythrocytes
that lack complement protection
with CD-59.
Eculizumab inhibits the cleavage
of C5 by the C5 convertase into
C5a a potent anaphylatoxin with
prothrombotic and proinflammatory
properties, and C5b, which then
forms the terminal complement
complex C5b-9 which also has
prothrombotic and proinflammatory
effects. Both C5a and C5b-9 cause
the complement-mediated events
that are characteristic of PNH and
aHUS.
The metabolism of eculizumab is
thought to occur via lysosomal en-
zymes that cleave the antibody to
generate small peptides and amino
acids. The volume of distribution of
Eculizumab in humans approxi-
mates that of plasma.
O U R K R I B I O L I S A ™ E C U L I Z U M A B E L I S A H A S A S E N S I T I V E R A N G E : 0 - 1 0 0 U G / M L
F O R P L A S M A M E A S U R E M E N T S .
KRIBIOLISA™ECULIZUMAB ELISA
KRIBIOLISA™ANTI-ECULIZUMAB ELISA
Therapeutic drug monitoring of Eculizumab: Rationale for an individualized dosing schedule
Philippe Gatault,1,2,3,* Guillaume Brachet,2,4,5 David Ternant,4,5,6 Danielle Degenne,2,4,5 Guillaume Récipon,2 Christelle Barbet,1 Emmanuel Gyan,4,5,7
Valérie Gouilleux-Gruart,2,4,5 Cécile Bordes,8,9 Alexandra Farrell,4,5 Jean Michel Halimi,1,3 and Hervé Watier2,4,5
Author information
1.Service de Néphrologie et Immunologie clinique; CHRU de Tours; France 2.Laboratoire d'Immunologie; CHRU de Tours; France
3.EA 4245; Université François-Rabelais de Tours; France 4.UMR 7292; Université François-Rabelais de Tours; France
5.UMR 7292 GICC; CNRS 6.Laboratoire de Pharmacologie-Toxicologie; CHRU de Tours; France
7.Service d'Hématologie et Thérapie Cellulaire; CHRU de Tours; France 8.CHU de Bordeaux; France; Laboratoire d'Immunologie; France
9.Université de Bordeaux; UMR 5164 CIRID; France
Discussion ... ... In conclusion, the use of a fixed eculizumab dose for maintenance therapy in PNH and aHUS is likely to be associated with
an excessive trough concentration in many patients, particularly those of low body weight. Given the high cost of treatment, it seems proba-
ble that major cost savings could be achieved by using therapeutic drug monitoring to tailor the dose of eculizumab to individual patient
needs, thus avoiding potentially unnecessary and excessive use of the drug and reducing the risk of side effects. However, results of this
pilot study should now be confirmed in larger cohorts of PNH and aHUS patients. ... ....
Measurement of Eculizumab Trough Levels ... ... The patient sera were diluted to 1:20 or 1:40 and incubated for 30 minutes at room tem-
perature, together with standards (0.5, 1, 5, 10, 25, 35 and 50 µg/mL eculizumab) and controls. ... ...
KRIBIOLISA™ ECULIZUMAB ELISA
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Eculizumab are pre-coated onto mi-
crowells. Samples and standards are pipetted into microwells and human Eculizumab present in the sample are bound by the capture
antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Eculizumab antibody is pipetted and incubated. After washing mi-
crowells in order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color devel-
ops proportionally to the amount of Eculizumab in the sample. Color development is then stopped by addition of stop solution. Absorb-
ance is measured at 450 nm.
KRIBIOLISA™ ANTI-ECULIZUMAB ELISA
The method employs the quantitative sandwich enzyme immunoassay technique. Eculizumab is pre-coated onto microwells. Samples
and standards are pipetted into microwells and antibodies to Eculizumab present in the sample are bound by the capture antibody.
Then, a HRP (horseradish peroxidase) conjugated Eculizumab is pipetted and incubated. After washing microwells in order to remove
any nonspecific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the
amount of Anti-Eculizumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at
450 nm.
KRIBIOLISA™ ECULIZUMAB ELISA
The Calibrators have been standardized against innovator drug- Soliris® sourced commercially.
KRIBIOLISA™ ANTI-ECULIZUMAB ELISA
The Calibrators have been standardized against antibodies to Eculizumab sourced commercially.
PRINCIPAL OF THE ASSAY + KIT PARAMETERS
CALIBRATORS VALIDATION + KIT PARAMETERS
PERFORMANCE CHARACTERISTICS + KIT PARAMETERS
KRIBIOLISA™ ECULIZUMAB ELISA
Sensitivity (LOD) : 0.2 UG/ML Precision: Inter/Intra Assay: < 10% Cross Reactivity: Eculizumab, 100%
KRIBIOLISA™ ANTI-ECULIZUMAB ELISA
Sensitivity (LOD) : 10.0 NG/ML Precision: Inter/Intra Assay: < 10% Cross Reactivity: Eculizumab, 100%
Soliris® is the registered trade mark of Alexion Inc.
High Sensitivity Assays:
Limit of Detection: 0.2 UG/ML
10 NG/ML
Seven Point Calibration Curve
for High Degree Of Accuracy
in Extrapolation of Samples