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. ATEZOLIZUMAB
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 ATEZOLIZUMAB ELISA
KRIBIOLISA ANTI-ATEZOLIZUMAB 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™ ATEZOLIZUMAB ELISA KRIBIOLISA™ ANTI-ATEZOLIZUMAB ELISA
KIT CATALOG NUMBER: KBI1027 KIT CATALOG NUMBER: KBI2027
TYPE OF ASSAY: ELISA, SANDWICH BASED TYPE OF ASSAY: ELISA, COMPETITIVE
SAMPLE MATRIX: SERUM, PLASMA, CELL CULTURE SAMPLE MATRIX: SERUM, PLASMA, CELL CULTURE
SUPERNATANT SUPERNATANT
CALIBRATOR RANGE: 0 - 600 NG/ML CALIBRATOR RANGE: 0 - 1600 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
ATEZOLIZUMAB -
PD-L1 BLOCKER DRUG
Drug Class: Monoclonal Antibod-
ies; PD-L1 Blocker
Atezolizumab is an Fc-engineered,
humanised immunoglobulin G1 (IgG1)
monoclonal antibody that directly binds
to PD-L1 and provides a dual blockade
of the PD-1 and B7.1 receptors, re-
leasing PD-L1/PD-1 mediated inhibi-
tion of the immune response, including
reactivating the anti-tumour immune
response without inducing antibody-
dependent cellular cytotoxicity.
Atezolizumab spares the PD-L2/PD-1
interaction allowing PD-L2/PD-1 medi-
ated inhibitory signals to persist.
Atezolizumab as monotherapy is indi-
cated for the treatment of adult pa-
tients with locally advanced or meta-
static urothelial carcinoma (UC):
• after prior platinum-containing chem-
otherapy, or
• who are considered cisplatin ineligi-
ble, and whose tumours have a PD-L1
expression ≥ 5%.
Atezolizumab is also indicated for the
treatment of adult patients with locally
advanced or metastatic non-small cell
lung cancer (NSCLC) after prior chem-
otherapy. Patients with EGFR activat-
ing mutations or ALK-positive tumour
mutations should also have received
targeted therapy before receiving Ate-
zolizumab.
O U R K R I B I O L I S A ™ A T E Z O 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 - 6 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™ATEZOLIZUMAB ELISA
KRIBIOLISA™ANTI-ATEZOLIZUMAB ELISA
Phase I dose-finding study of monotherapy with atezolizumab, an engineered immunoglobulin monoclonal antibody targeting
PD-L1, in Japanese patients with advanced solid tumors
Hidenori Mizugaki, 1 Noboru Yamamoto, corresponding author1 Haruyasu Murakami, 2 Hirotsugu Kenmotsu, 2 Yutaka Fuji-
wara,1 Yoshimasa Ishida, 3 Tomohisa Kawakami, 3 and Toshiaki Takahashi 2
1.Department of Experimental Therapeutics, Exploratory Oncology Research & Clinical Trial Center, National Cancer Center
Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan. 2. Division of Thoracic Oncology, Shizuoka Cancer Center, 1007
Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777 Japan. 3. Chugai Pharmaceutical Co., Ltd, 2-1-1 Nihon-
bashi-Muromachi, Chuo-ku, Tokyo, 103-8324 Japan.
Pharmacokinetics
Serum samples for PK analyses were collected at Cycle 1, Days 1 (before infusion, 30 ± 30 min after infusion), 2 (24 ± 6 h
after infusion), 4 (72 ± 12 h after infusion), 8 (± 1 day), 15 (± 1 day), and 22 (± 1 day); Cycles 2, 3, and 4, Days 1 (30 ± 30 min
after infusion) and 22 (± 1 day); Cycles 5 and 7, Day 1 (30 ± 30 min after infusion); and Cycle 6 onward, Day 22 of even-
numbered cycles (± 1 day). The blood samples were centrifuged at 1500 to 2000×g for 15 min at 4 °C. The serum samples
were then stored at −70 °C or less. The concentrations of atezolizumab in human serum were measured using ELISA, with
the lower limit of quantification of 60 ng/mL.
KRIBIOLISA™ ATEZOLIZUMAB ELISA
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Atezolizumab are pre-coated onto mi-
crowells. Samples and standards are pipetted into microwells and human Atezolizumab present in the sample are bound by the capture
antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Atezolizumab 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 Atezolizumab in the sample. Color development is then stopped by addition of stop solution. Ab-
sorbance is measured at 450 nm.
KRIBIOLISA™ ANTI-ATEZOLIZUMAB ELISA
The method employs the competitive enzyme immunoassay technique. Atezolizumab is pre-coated onto microwells. Samples or stand-
ards along with the tracer are pipetted into microwells and antibodies to Atezolizumab present in the standards or sample will compete
with tracer and bound by the capture antibody. After washing microwells, HRP conjugate is pipetted and incubated. Free HRP conju-
gate will be removed by washing cycle. The ready to use substrate solution (TMB) is added to microwells and color develops inversely
proportionally to the amount of Anti-Atezolizumab present in the sample. Color development is then stopped by addition of stop solu-
tion. Absorbance is measured at 450 nm.
KRIBIOLISA™ ATEZOLIZUMAB ELISA
The Calibrators have been standardized against innovator drug - Tecentriq® sourced commercially.
KRIBIOLISA™ ANTI-AEZOLIZUMAB ELISA
The Calibrators have been standardized against antibodies to Atezolizumab sourced commercially.
PRINCIPAL OF THE ASSAY + KIT PARAMETERS
CALIBRATORS VALIDATION + KIT PARAMETERS
PERFORMANCE CHARACTERISTICS + KIT PARAMETERS
KRIBIOLISA™ ATEZOLIZUMAB ELISA
Sensitivity (LOD) : 50 NG/ML Precision: Inter/Intra Assay: < 10% Cross Reactivity: Atezolizumab, 100%
KRIBIOLISA™ ANTI-ATEZOLIZUMAB ELISA
Sensitivity (LOD) : 25 NG/ML Precision: Inter/Intra Assay: < 10% Cross Reactivity: Atezolizumab, 100%
Tecentriq® is the registered trade mark of Genentech Inc.
High Sensitivity Assays:
Limit of Detection: 50 NG/ML
25 NG/ML
Seven Point Calibration
Curve for High Degree Of
Accuracy