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Avelumab (Bavencio®) ELISA Kit

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ELISA Kit Technical Manual

Avelumab (Bavencio®) ELISA Kit

Enzyme immunoassay for the quantitative determination of free Avelumab (Bavencio®) in serum and plasma.Enzyme immunoassay for the quantitative determination of free Avelumab (Bavencio®) in serum and plasma. The ELISA Genie Shikari Q-AVE ELISA has been especially developed for the quantitative analysis of free avelumab in serum and plasma samples.

Product Information

ApplicationFree drug
Required Volume (μl)10
Total Time (min)70
Sample TypeSerum, Plasma
Number of Assays96
Detection Limit (ng/mL)10 (ng/mL)
Spike Recovery (%)85-115%
Shelf Life (year)1

About Avelumab (Bavencio®)

Avelumab (Bavencio®) (also known as MSB0010718C) is an investigational fully human anti-PD-L1 IgG1 lambda monoclonal antibody that has a molecular weight of approximately 147 kDa. By inhibiting PD-L1 interactions, avelumab is thought to enable the activation of T-cells and the adaptive immune system. By retaining a native Fc-region, avelumab is thought to engage the innate immune system and may induce antibody-dependent cellmediated cytotoxicity (ADCC). Importantly, avelumab has not shown antibody-dependent cellmediated cytotoxicity against immune cell subsets in humans. Mechanism of Action PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation and cytokine production. Avelumab binds PD-L1 and blocks the interaction between PD-L1 and its receptors PD1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the immune response resulting in the restoration of immune responses, including anti-tumor immune responses. Avelumab has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In syngeneic mouse tumor models, blocking PD-L1 activity resulted in decreased tumor growth. Pharmacokinetics The pharmacokinetics of avelumab was studied in 1629 patients who received doses ranging from 1 to 20 mg/kg every 2 weeks. The data showed that the exposure of avelumab increased dose-proportionally in the dose range of 10 to 20 mg/kg every 2 weeks. Steady-state concentrations of avelumab were reached after approximately 4 to 6 weeks (2 to 3 cycles) of repeated dosing, and the systemic accumulation was approximately 1.25-fold. According to FDA's data, Cmax value was found 301 ?g/mL and Cmin value was found as 22 ?g/mL. In observed ADA-positive patients, the Cmin value was increased to 27,2 ?g/mL, while in ADA-negative patients, this value decreased to 14,1 ?g/mL. Distribution The geometric mean volume of distribution at steady state for a subject receiving 10 mg/kg was 4.72 L Elimination The primary elimination mechanism of avelumab is proteolytic degradation. Based on population pharmacokinetic analyses in patients with solid tumors, the total systemic clearance was 0.59 L/day and the terminal half-life was 6.1 days in patients receiving 10 mg/kg. In a post hoc analysis, avelumab clearance was found to decrease over time in patients with MCC, with a mean maximal reduction (% coefficient of variation [CV%]) from baseline value of approximately 41.7% (40.0%). Specific populations Body weight was positively correlated with total systemic clearance in population pharmacokinetic analyses. No clinically meaningful differences in pharmacokinetics were observed in the clearance of avelumab based on age; sex; race; PD-L1 status; tumor burden; mild [calculated creatinine clearance (CLcr) 60 to 89 mL/min, n=623 as estimated by the Cockcroft-Gault formula], moderate [CLcr 30 to 59 mL/min, n=320] or severe [CLcr 15 to 29 ml/min, n=4] renal impairment; and mild [bilirubin less than or equal to ULN and AST greater than ULN or bilirubin between 1 and 1.5 times ULN, n=217] or moderate [bilirubin between 1.5 and 3 times ULN; n=4] hepatic impairment. There are limited data from patients with severe hepatic impairment [bilirubin greater than 3 times ULN, n=1], and the effect of severe hepatic impairment on the pharmacokinetics of avelumab is unknown. 4 Immunogenicity As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to avelumab in the studies described below with the incidence of antibodies in other studies or to other products may be misleading. Of 1738 patients treated with BAVENCIO 10 mg/kg as an intravenous infusion every 2 weeks, 1558 were evaluable for treatmentemergent anti-drug antibodies (ADA) and 64 (4.1%) tested positive. The development of treatment-emergent ADA against avelumab did not appear to alter the pharmacokinetic profile or risk of infusionrelated reactions. The use of avelumab (Bavencio®) was associated to the development of anti-avelumab antibodies, even some might be neutralizing, in various percentages of patients during therapy with the drug. The Elisa Genie Avelumab-ELISA and Antibody to Avelumab ELISA Kits can be efficiently used, for monitoring serum through levels and the presence of anti-avelumab antibodies respectively, during therapy and offers the scientist a tool for decision on possible preventive measures.

Avelumab (Bavencio®) ELISA Kit test principle

Solid phase enzyme-linked immunosorbent assay (ELISA) based on the sandwich principle. Standards and samples (serum or plasma) are incubated in the microtitre plate coated with the reactant for Avelumab (Bavencio®). After incubation, the wells are washed. A horse radish peroxidase (HRP) conjugated probe is added and binds to avelumab captured by the reactant on the surface of the wells. Following incubation wells are washed and the bound enzymatic activity is detected by addition of chromogen-substrate. The colour developed is proportional to the amount of avelumab in the sample or standard. Results of samples can be determined directly using the standard curve


BAVENCIO is a trademark of MERCK KGAA

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