Anti-drug Antibody Preparation

Medicilon has rich experience in ADA development and has successfully delivered more than 100 projects. Medicilon can provide high-affinity and specific polyclonal anti-drug antibody development services with short development cycles and low costs.

Immunogenicity refers to the immune response generated by the immune system against drugs entering the human body. The immune response produces anti-drug antibodies (ADA) that specifically bind to drug molecules. In the process of drug development, especially for macromolecular drugs, small molecule and peptide drugs, and even related adjuvants, they may directly or indirectly cause a large immunogenic reactions. Mild reactions may lead to the termination of projects in the preclinical or clinical stages, resulting in the loss of early economic investments. Severe reactions may reduce drug efficacy, cause allergic reactions, and even pose a threat to life safety.
According to current FDA guidelines, all serious immune responses, including acute hypersensitivity and neutralizing antibody responses, must be excluded during drug development. Therefore, ADA (Anti-Drug-Antibody)—effective detection in PK research, that is, systematic and scientific completion of ADA detection is an urgent issue in PK research.
The evaluation of immunogenicity is mainly carried out by anti-drug antibody (anti-drug antibody, ADA) analysis method. In order to effectively evaluate the immunogenicity of antibody drugs in preclinical and clinical research, it is particularly important to develop reliable ADA assessment and detection methods.. Analytical techniques include ELISA, ECL, SPR, RIA, MSD, etc., and one or several combinations can be flexibly adopted. Currently, the most commonly used techniques are ECL and MSD.
High-sensitivity and diverse polyclonal anti-drug antibodies can be used as a positive reference in immunogenicity studies, simulating the situation of ADA production in the human body. They can also specifically detect the level of antibody drugs in the body, making them important reagents for pharmacokinetic studies. Therefore, as essential tools in the development of antibody drugs, anti-drug antibodies are not only indispensable for clinical applications but also widely used in clinical stages.
Medicilon has rich experience in ADA development and has successfully delivered more than 100 projects. Medicilon can provide high-affinity and specific polyclonal anti-drug antibody development services with short development cycles and low costs.

Development process

（1）Antigen preparation
Antigen detection (1-2 days)Antigen reviewAntigen preparation (2 weeks)Conjugation or enzymatic cleavage of the full-length antibody drug provided by the client.
（2）Immunization and serum testing
Immunization and serum titer testing (8 weeks)Blood collection before immunization, animal immunization, titer testing, final blood collection, provide immunization schedule and titer test report; titer meets ≥1:729,000
（3）Antibody purification
Antibody purification (2 weeks)Protein A purificationAntigen affinity chromatographyTotal human IgG de-cross-purified (optional)Other proteins to cross-purify (optional)
（4）Antibody detection
Antibody identification (1 week)SDS-PAGE purity analysis, UV concentration determinationTotal human IgG cross-reactivity;<2% cross-reactivity
（5）Delivery
Delivery (12 weeks)Purified antibody, titer ≥1:243,000, quantity (optional)COAProject Development Detailed Report

Advantage

Rich experience: More than 10 years of service development experience, one-to-one communication to customize projects, real-time feedback on experimental situations.Various types: Full-length antibodies, antibody fragments, small molecule drugs, peptide drugs, ADC drug conjugates, vaccines, etc.High quality:Guaranteed delivery sensitivity, cross-reactivity meeting regulatory requirements for PK/ADA detection antibodies.Various purification methods:Protein A/G, antigen affinity, Human IgG, isotype IgG, interfering protein, etc.

Case

Case 1-ADC Drug

Serum titer

Antibody titer after purification
Case 2-Antibody drug human IgG decrossover

Serum titer

Antibody titer after purification

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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