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

What is preclinical testing?

In the process of preclinical testing of a compound or biological agent into a drug, the compound involved must go through the testing phase. First, we need to identify potential targets that can treat the disease. Then, a variety of compounds or preparations are screened out. Any compound that has shown potential as a drug for the treatment of this disease needs to be tested for toxicity before clinical testing to reduce the possibility of injury. preclinical testing What is the basis of preclinical testing? According to US Food and Drug Administration (FDA) regulations, a series of tests are required before a new drug is approved for use. In the first stage, basic research determines a hypothetical target for the treatment of a certain disease, and then screens small molecules or biological compounds to discover any substance with the potential to treat the disease. Then, a preclinical research phase followed, before which, as described above, the potential toxicity of the compou

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Inventory of the three major in vitro pharmacokinetic research methods

The metabolic properties of a compound are an essential factor in whether or not it can be used as a drug in the clinical setting, so pharmacokinetic studies of newly synthesized compounds are required in drug development. In vitro incubation with liver microsomes, recombinant CYP450 enzyme lines, and in vitro incubation with hepatocytes are some of the more common in vitro drug metabolism methods. 1. In vitro incubation method with liver microsomes The metabolic stability and metabolic phenotypes of candidate compounds in different species of liver microsomes are good predictors of the metabolic properties of compounds in vivo. They are practical tools for evaluating candidate compounds in the pre-development phase of drug development. Liver microsomes include rat liver microsomes, human liver microsomes, canine liver microsomes, monkey liver microsomes, and mouse liver microsomes. In in vitro incubation of the liver, microsomes are the "gold standard" for in vitro d

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Novel Parkinson’s Therapies Possible with New Mouse Model

Parkinson's disease (PD) is a neurodegenerative disorder that is marked by the accumulation of the protein, α-synuclein (αS), into clumps known as Lewy bodies, which diminish neural health. Now, researchers from Brigham and Women's Hospital (BWH) report the development of a mouse model to induce PD-like αS aggregation, leading to resting tremor and abnormal movement control. The mouse responds to L-DOPA, similarly to patients with PD. The team's study (“Abrogating Native α-Synuclein Tetramers in Mice Causes a L-DOPA-Responsive Motor Syndrome Closely Resembling Parkinson’s Disease”) on the use of this transgenic mouse model appears in Neuron . “α-Synuclein (αS) regulates vesicle exocytosis but forms insoluble deposits in PD. Developing disease-modifying therapies requires animal models that reproduce cardinal features of PD. We recently described a previously unrecognized physiological form of αS, α-helical tetramers, and showed that familial PD-causing missense mutati

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