Therapeutic Drug Monitoring

Atezolizumab (Tecentriq®)Antibody screening - Qualitative ELISA Kit

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SKU:
HUMB00061
Product Type:
ELISA Kit
ELISA Type:
Biosimilar ELISA
Biosimilar ELISA Type:
Qualitative
Applications:
ELISA
Reactivity:
Human
Analytes:
Atezolizumab (Tecentriq®)
Research Area:
Checkpoint Inhibitors

Description

Atezolizumab (Tecentriq®) Antibody screening - Qualitative ELISA Kit

Assay Genie Qualitative Antibodies to Atezolizumab ELISA has been especially developed for the qualitative analysis of antibodies to atezolizumab in serum and plasma samples. Assay Genie Qualitative Antibodies to Atezolizumab ELISA is optimized with Tecentriq®.

Atezolizumab (Tecentriq®) Antibody screening - Qualitative ELISA Kit Test Principle

Solid phase enzyme-linked immunosorbent assay (ELISA) based on the sandwich principle. Controls and samples (serum or plasma) are incubated in the microtiter plate coated with the drug atezolizumab. After incubation, the wells are washed. Then, horseradish peroxidase (HRP) conjugated probe is added and binds to atezolizumab antibodies captured by the drug atezolizumab on the surface of the wells. Following incubation wells are washed and the bound enzymatic activity is detected by addition of chromogen-substrate. Finally, the reaction is terminated with an acidic stop solution. The colour developed is proportional to the amount of atezolizumab antibodies in the sample or controls. The results can be evaluated with using cutoff value.

Atezolizumab (Tecentriq®) Antibody screening - Qualitative ELISA Kit Product Information

Key Information Description

Application

Antibody screening - Qualitative

Required Volume

10 µl

Total Time

140 minutes

Sample Type

Serum, Plasma

Number of Assays

96

Detection Limit

+ / - ng/mL

Spike Recovery

-

Shelf Life (year)

1

Alternative Names

-

About Atezolizumab (Tecentriq®) Antibody screening - Qualitative ELISA Kit

Atezolizumab is a humanized monoclonal antibody used to prevent the interaction of PD-L1 and PD-1, removing inhibition of immune responses seen in some cancers. Atezolizumab is a humanized IgG antibody that binds PD-L1, preventing its interaction with PD-1 and B7-1. Preventing the interaction of PD-L1 and PD-1 removes inhibition of immune responses such as the anti-tumor immune response but not antibody dependent cellular cytotoxicity. Atezolizumab is indicated to treat locally or advanced metastatic urothelial carcinoma in patients ineligible for cicplatin-containing chemotherapy with tumors expressing PDL1, in patients ineligible for cisplatin-containing chemotherapy irrespective of PD-L1, have disease progression following platinum containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant chemotherapy. Atezolizumab is also indicated first line for non small cell lung cancer in combination with bevacizumab, paclitaxel, and carboplatin with no EGFR or ALK genomic abnormalities. It can be used in patients with disease progression during or after platinum containing chemotherapy even if they have EGFR and ALK abnormalities. 3 Atezolizumab is indicated in combination with paclitaxel protein-bound to treat locally advanced or metastatic triple negative breast cancer expressing PD-L1.

Therapeutic drug monitoring (TDM) is the clinical practice of measuring specific drugs at designated intervals to maintain a constant concentration in a patient's bloodstream, thereby optimizing individual dosage regimens. The indications for drug monitoring include efficacy, compliance, drug-drug interactions, toxicity avoidance, and therapy cessation monitoring. Additionally, TDM can help to identify problems with medication compliance among noncompliant patient cases.

Biologic medicinal products (biologics) have transformed treatment landscapes worldwide for patients with haematological or solid malignancies with the 21st century. Today, as data exclusivity periods of first wave biologics approach expiration/have expired, several biosimilar products (i.e.,biologics that are considered to be similar in terms of quality, safety and efficacy to an approved ‘reference’ biologic) are being developed or have already been approved for human use.

Like all biologics, biosimilars are structurally complex proteins that are typically manufactured using genetically engineered animal, bacterial or plant cell culture systems. As a consequence of this molecular complexity and the proprietary nature of the manufacturing process, which will inevitably result in the use of different host cell lines and expression systems as well as related differences in manufacturing conditions, it is not possible to manufacture exact copies of a reference biologic.

When administered to patients, all therapeutic proteins have the potential to induce an unwanted immune response (i.e.,to stimulate the formation of antidrug antibodies [ADAs]). The impact of immune responses can range from no apparent effect to changes in pharmacokinetics, loss of effect and serious adverse events. Furthermore, the immunogenicity profile of a biologic can be significantly altered by even small differences in its manufacturing process that are accompanied by a change in product attributes, as well as differences in dosing schedules, administration routes or patient populations.

Assay Genie Atezolizumab ELISA Products

Product Application SKU

Atezolizumab (Tecentriq®)

Free Drug

Atezolizumab (Tecentriq®)

Antibody screening - Qualitative

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