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. RANIBIZUMAB
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 RANIBIZUMAB ELISA
KRIBIOLISA ANTI-RANIBIZUMAB 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™ Tocilizumab (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-Tocilizumab (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™ RANIBIZUMAB ELISA KRIBIOLISA™ ANTI-RANIBIZUMAB ELISA
KIT CATALOG NUMBER: KBI1029 KIT CATALOG NUMBER: KBI2029
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 - 500 NG/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
RANIBIZUMAB -
VEGF-A INHIBITOR
Drug Class: Monoclonal Antibodies;
VEGF-A Inhibitor
Ranibizumab is a recombinant human-
ized IgG1 kappa isotype monoclonal
antibody fragment designed for intra-
ocular use. Ranibizumab binds to and
inhibits the biologic activity of human
vascular endothelial growth factor A
(VEGF-A).
Ranibizumab is a VEGF-A antagonist
that binds to and inhibits the biologic
activity of active forms of human VEGF
-A, including the cleaved form
(VEGF110). VEGF-A has been shown
to cause neovascularization
(angiogenesis) and an increase in
vascular permeability, which is thought
to contribute to the progression of the
neovascular form of age-related macu-
lar degeneration (AMD).
Ranibizumab has a molecular weight
of approximately 48 kilodaltons and is
produced by an E. coli expression sys-
tem in a nutrient medium containing
the antibiotic tetracycline (tetracycline
is not detectable in the final product).
It is indicated by FDA for the treatment
of macular edema after retinal vein
occlusion, age-related macular degen-
eration (wet), and diabetic macular
edema.
O U R K R I B I O L I S A ™ R A N I B 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 - 5 0 0 N G / M L
F O R S E R U M M E A S U R E M E N T S .
KRIBIOLISA™RANIBIZUMAB ELISA
KRIBIOLISA™ANTI-RANIBIZUMAB ELISA
SYSTEMIC PHARMACOKINETICS AND PHARMACODYNAMICS OF INTRAVITREAL AFLIBERCEPT, BEVACIZUMAB,
AND RANIBIZUMAB
Robert L. Avery, MD, Alessandro A. Castellarin, MD,* Nathan C. Steinle, MD,* Dilsher S. Dhoot, MD,* Dante J. Pieramici, MD,* Robert See,
MD,* Stephen Couvillion, MD,* Ma'an A. Nasir, MD,* Melvin D. Rabena, BS,* Mauricio Maia, PhD,† Sherri Van Everen, PharmD,† Kha Le,
PhD,† and William D. Hanley, PhD†
*California Retina Consultants, Santa Barbara, California; and †Genentech, Inc, South San Francisco, California.
Purpose:
To evaluate the systemic pharmacokinetics (PKs) of aflibercept, bevacizumab, and ranibizumab in patients with neovascular age-related
macular degeneration (AMD), diabetic macular edema (DME), or retinal vein occlusion (RVO).
Sample Collection and Bioanalytical Methods
... Analyses of serum drug levels and plasma concentrations of free-VEGF have been described in detail previously. CTAD (citrate, theo-
phylline, adenosine, and dipyridamole) tubes were used for the collection of plasma samples because of their ability to preserve platelets
and prevent activation.VEGF was measured in plasma samples, as opposed to serum, to prevent or minimize release of VEGF from plate-
lets. Serum levels of aflibercept, bevacizumab, and ranibizumab were analyzed using solution phase enzyme-linked immunosorbent as-
says (ELISA). The lower limits of quantitation (LLOQ) for aflibercept, bevacizumab, and ranibizumab were 1,000 pg/mL, 313 pg/mL, and
15.0 pg/mL, respectively. Plasma concentrations of free-VEGF were determined using the ... ELISA kit, with an LLOQ of 10 pg/mL.
KRIBIOLISA™ RANIBIZUMAB ELISA
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Ranibizumab are pre-coated onto mi-
crowells. Samples and standards are pipetted into microwells and human Ranibizumab present in the sample are bound by the capture
antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Ranibizumab 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 Ranibizumab in the sample. Color development is then stopped by addition of stop solution. Ab-
sorbance is measured at 450 nm.
KRIBIOLISA™ ANTI-RANIBIZUMAB ELISA
The method employs the quantitative sandwich enzyme immunoassay technique. Ranibizumab is pre-coated onto microwells. Samples
and standards are pipetted into microwells and antibodies to Ranibizumab present in the sample are bound by the capture antibody.
Then, a HRP (horseradish peroxidase) conjugated Ranibizumab 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-Ranibizumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at
450 nm.
KRIBIOLISA™ RANIBIZUMAB ELISA
The Calibrators have been standardized against innovator drug- Lucentis® sourced commercially.
KRIBIOLISA™ ANTI-RANIBIZUMAB ELISA
The Calibrators have been standardized against antibodies to Ranibizumab sourced commercially.
PRINCIPAL OF THE ASSAY + KIT PARAMETERS
CALIBRATORS VALIDATION + KIT PARAMETERS
PERFORMANCE CHARACTERISTICS + KIT PARAMETERS
KRIBIOLISA™ RANIBIZUMAB ELISA
Sensitivity (LOD) : 1.00 NG/ML Precision: Inter/Intra Assay: < 10% Cross Reactivity: Ranibizumab, 100%
KRIBIOLISA™ ANTI-RANIBIZUMAB ELISA
Sensitivity (LOD) : 8.00 NG/ML Precision: Inter/Intra Assay: < 10% Cross Reactivity: Ranibizumab, 100%
Lucentis® is the registered trade mark of Genentech Inc.
High Sensitivity Assays:
Limit of Detection: 1.0 NG/ML
8.0 NG/ML
Seven Point Calibration Curve
for High Degree Of Accuracy