Embodiments of the present disclosure provide a nanoparticle based platform, and nanoallergens for identifying, evaluating and studying allergen mimotopes as multiple copies of a single mimotope or various combinations on the same particle. The nanoparticle is extremely versatile and allows multivalent binding to IgEs specific to a variety of mimotopes, simulating allergen proteins. Nanoparticles can include various molecular ratios of components. For example, the nanoallergens can include about 0.1-40% mimotope-lipid conjugate and about 60-99.9% lipid. The mimotope-lipid conjugate includes a mimotope, a first linker, and lipid molecule. Nanoallergens can be used in in vitro and in vivo applications to identify a specific patient's sensitivity to a set of epitopes and predict a symptomatic clinical response, identify allergen epitopes through blind screening peptide sequences from allergen protein, and in a clinical application similar to a scratch test.

One aspect as reported herein is a method for detecting a rat antibody in a serum or plasma sample (obtained) from a mouse comprising the steps of a) providing the sample to be analyzed, b) incubating said serum or plasma sample with an antibody that specifically binds to rat IgG and that does not specifically bind to mouse IgG, wherein the antibody is i) a mixture of an antibody binding to rat kappa light chain and an antibody binding to rat lambda light chain, or ii) a mixture of an antibody binding to rat IgG1 with an avidity of 4.1×10.sup.10 M.sup.−1 or more, an antibody binding to rat IgG2a with an avidity of 8.6×10.sup.9 M.sup.−1 or more, an antibody binding to rat IgG2b with an avidity of 6.4×10.sup.10 M.sup.−1or more and an antibody binding to rat IgG2c with an avidity of 9.5×10.sup.10 M.sup.−1 or more, c) optionally incubating said sample with a reagent appropriate for the selective detection of total, active or antigen-bound rat antibody, and d) correlating the complex formed in (b) or (c) to the concentration of the rat antibody in the sample.

The invention relates to methods and products for the identification of a clinically significant immune response in subjects treated with a therapeutic protein. Aspects of the invention relate to methods and compositions for identifying a clinically significant immune response in patients treated with therapeutic amounts of a VLA4 binding antibody (e.g., natalizumab).

Herein is reported a method for selecting an antibody with a systematic clearance in cynomolgus monkeys of less than 8 mL/kg/day comprising the steps of measuring the retention time of the antibody on performing an FcRn affinity chromatography with a positive linear pH gradient and on a heparin affinity chromatography with a positive linear conductivity/salt gradient, and selecting an antibody that has a relative retention time on the FcRn affinity chromatography column is less than 1.78 times the retention time difference between peaks 2 and 3 the retention time of preparation of an oxidized anti-Her3 antibody of SEQ ID NO: 03 and 04, and a relative retention time on the heparin affinity chromatography column is less than 0.87 times the retention time of an anti-pTau antibody of SEQ ID NO: 01 and 02.

The present invention provides a panel of at least five clinical analyses or tests (using serum samples) to determine the risk of pediatric acute-onset neuropsychiatric syndrome (PANS) and/or pediatric autoimmune neuropsychiatric disorder associated with streptococcal infection (PANDAS) in an individual. These include enzyme linked immunosorbent assays (ELISAs) to measure antibody titers against neuronal antigens present in the brain; the neuronal antigens include lysoganglioside, tubulin, dopamine receptor D1, dopamine receptor D2, serotonin receptor 5HT2A, and serotonin receptor 5HT2C. Antibody titers against at least four of these neuronal antigens are required in the present methods; preferably antibody tiers against all of these neuronal antigens are measured. A final assay is used to quantify calcium/calmodulin-dependent protein kinase activity using a neuronal cell line. The results of these analyses or tests are then combined using an algorithm to determine whether a PANS or PANDAS diagnosis is appropriate for the individual. Depending on the diagnosis, an appropriate treatment can be determined.

Thus, herein is reported a method for analyzing/characterizing circulating immune complexes (CICs) formed in vivo comprising a size-exclusion chromatography of a sample obtained from a mammal to which the drug had been administered at least once for determining the weight/size of the immune complexes, optionally a second non-SEC chromatography, and at least one immunoassay, whereby the immune complex is characterized by the correlation of the immune complex size and the immunoassay result/read-out. Also reported herein is the use of a method as reported herein for determining a correlation to altered pharmacokinetics, for determining loss or reduction of efficacy, for determining neutralization of natural counterparts of the drug, for determining immune and hypersensitivity reactions, including serum sickness/type III hypersensitivity reaction/immune complex-mediated disease.

The present disclosure is directed to human monoclonal IgE antibodies, and IgG antibodies engineered therefrom. Such engineered antibodies can be used to blunt pathologic IgE responses in subjects, such as in the treatment or prevention of allergies.

A lateral flow immunoassay for the detection of anti-drug antibodies against a biological drug includes a membrane having a capture area, a sample application area, a flow path from the sample application area to the capture area, and a conjugate area located in the flow path. The conjugate area has said biological drug detectably labeled and the capture area has said biological drug immobilized thereto.

The present invention concerns methods for selecting and producing idiotype vaccines, and in particular methods for selecting and producing an idiotype vaccine for treatment of a B-cell derived malignancy in a subject based on the clonal profile (clonotype) of the malignancy; a method for producing an updated idiotype vaccine matched to a B-cell derived malignancy exhibiting a shifting clonal profile; and the high-fidelity idiotype vaccines produced using the methods. The invention also includes idiotype vaccines produced using the described methods and methods of treating B-cell derived malignancies using the produced vaccines.

The invention provides methods and compositions for early diagnosis and treatment of a disease associated with a specific antibody by employing the detection of a cross-idiotypic epitope on the specific antibody to detect the cells that produce the antibody before the development of clinical symptoms of the disease.