Immunogenicity Testing of Medicilon

Immunogenicity testing is focused on the detection and characterization of anti-drug antibodies (ADAs) and the determination whether these ADAs are neutralizing antibodies(NABs), as NABs may affect the pharmacokinetics (PK) of the drug. It is clear however that animal studies are not considered relevant to predict immunogenicity in humans. Still, the selection of the mini-pig to explore their possibilities for immunogenicity testing of biopharmaceuticals, especially to assist in the interpretation of safety studies, is based on the improved knowledge that various physiological aspects of Göttingen Minipigs® resemble more the human situation than other animal species. It is expected therefore that in the near future the safety testing, including immunogenicity testing of biopharmaceuticals in mini-pigs will increase as an alternative for non human primate studies, which use will be limited or restricted.

Immunogenicity Services

Screening assays for detection of positive samples for Anti-Drug Antibodies (ADA)
Confirmatory assays for ruling out false positive results
Characterization assays to determine the avidity and the isotypes of ADA
Neutralizing assays to assess the drug function inhibition capabilities of ADA
Cellular immune response assays to study the cellular immunogenicity

Immunogenicity Techniques

> Immunoassays:

Electrochemiluminiscence (ECLA / Meso Scale Discovery)
Radioimmunoassay (RIA)
Enzyme-linked immunosorbent assay (ELISA)

> Cell-based Assays:

• Fluorescence and luminescence
• Flow cytometry

> Label-free Interaction Analysis

• Surface plasmon resonance (SPR / Biacore)

Challenges in Immunogenicity Assay

Matrix Interference

Drug Interference

– Many of the therapeutic drugs, particularly an antibody therapeutic, have a long half-life (typically 10-20 days) and often administered chronically at high dose levels without a drug wash-out period.
– Immunogenicity assessments to such therapeutics pose unique challenges in clinical trials especially when significant drug interference is encountered.
– Free drug can complex with anti-drug antibodies directly interferes with the assay.
– Tolerance of the ADA assay for presence of drug to be determined.

Target Interference

– Target interference is also a big concern in bridging immunoassays, especially when target is a soluble receptor.

– Target interference can also be intensified by AD which then release target from target-drug complex.

Our team developed custom bridging assays for new materials that were introduced into the manufacturing processes, to determine their individual immunogenicity profiles. We also re-validated the prior assays with a new positive control that was comparable to the altered biotherapeutic. We then compared the results from these newly validated assays to those from the previous assays to measure any changes in the immunogenicity risk profile of the therapeutic.

Contact Us

Email : marketing@medicilon.com
Tel : +86 021 58591500

Tips: Above is part of immunogenicity testing and immunogenicity assay. You can also CONTACT US with any question or enquiry you may have. We will be happy to discuss your needs in detail and design an appropriate plan of action.

Medicilon Immunogenicity Test Service

Immunogenicity Testing of Medicilon

Factors Affecting the Immunogenicity of Biological Drugs

In Vitro Enzyme Activity Assay

Kinases play extensive and important roles in signal transduction and co-ordination of complex functions. Currently, about 300 kinase inhibitors have been approved for marketing, among which receptor tyrosine kinase (RTK) inhibitors are the main ones. Medicilon provides high-quality kinase profile screening and has one-stop kinase research services from assay development, high-throughput screening to selectivity analysis. In addition, Medicilon provides many other enzyme activity screens. Wide Variety Provides 200+ in vitro enzymatic detection methods; 100+ kinases, including CTK, RTK, AGC, CMGC and other kinase families as well as important common mutations Project Flexibility Various types of plates for screening, such as 96 and 384; Multiple flexible kinase profiles, including TK kinase family, CDK kinase family, etc., to meet different customer customization needs. Various Methods Fluorescence detection; Chemiluminescence detection; Absorbance detection LanthaScr...

阅读全文

Fluorescence Probes Synthesis

Medicilon's fluorescent probes and labeling platforms can provide fluorescent probe design and synthesis services for scientific institutions, drug R&D companies, and other customers. Design and synthesis steps Fluorescent probes are tools used to detect, measure and analyze biomolecules, cells and tissues. They achieve these purposes by emitting and receiving fluorescent signals. Medicilon can complete the design and synthesis of fluorescent probes for biomolecules. Selection of target molecules and determination of target. Selection of fluorescent dyes. Design of molecular structure. Synthesize probe molecules. Testing the properties of probe molecules. Custom synthesis Medicilon's fluorescent probes and labeling platforms can provide fluorescent probe design and synthesis services for scientific institutions, drug R&D companies, and other customers. After years of development, Medicilon's fluorescent probes and labeling platforms have accumulated rich experience...

阅读全文

Custom Synthesis

Medicilon has synthesized over 10,000 individual compounds from gram to kilogram quantities, and many compounds are synthesized with more than ten synthetic steps. The overall synthesis success rate is over 95%. High quality products from mg to kg scale Reagents, intermediates, building blocks, and scaffolds Preparation of API or reference standards Development of synthetic routes for impurities and metabolites On-site analytical support Product delivered with COA Medicilon offers integrated drug discovery services -- Chemistry, Biology & Preclinical Services

阅读全文

Shanghai Medicilon Inc.

搜索此博客