Nonclinical Services

Immunoassay and Antibody Purification

At LSIM Safety Institute, we have extensive experience of antibody purification and development of immunoassay (RIA and ELISA). We offer TK/PK of biopharmaceuticals such as peptides and antibody pharmaceuticals.
We have expertise in various biomarker assays and contribute to clarifying toxicity and effectiveness of drugs.

In addition, we can prepare monoclonal and polyclonal antibodies (containing purification of antibodies and labeled antibodies).
We also have experience in areas requiring advanced knowledge and technology, such as development of measurement systems using antibodies.
Affinity analysis of antibodies using Biacore as well as quantification of antibodies against biopharmaceuticals etc. are also carried out at LSIM. Please do not hesitate to contact us.

Services

• 1.Immunoassay method; TK/PK analysis, antibody assay

  • 1.1Development of Immunoassay method (ELISA, RIA)

    Measurement of biopharmaceutical concentration in blood is generally carried out by immunoassay.
    Based on our experience of immunochemistry technology handling antibodies and vast experience of immunoassay, we provide high quality service in the development of biopharmaceuticals.

  • 1.2Validation of TK/PK analysis for immunoassay, sample assay (Compliance to GLP regulations and criteria for reliability of application data)

    We develop and validate assays to measure blood concentrations of biopharmaceuticals and anti-drug antibodies.

  • 1.3Anti-drug antibody assay (ELISA, RIP, BIACORE, Bio-assay)

    We monitor appearance of anti-drug antibodies against biopharmaceuticals administered to animals or humans.

• 2.Antibody purification

  • 2.1Preparation of antibody and bulk production

    Monoclonal antibody (administration to animal and antibody titer assay, cell fusion/cloning, establishment of hybriboma, culture supernatant etc.)

    Polyclonal antibody; preparation and purification of antigen, preparation of conjugated antigen, administration to animal, antibody titer assay etc.)

  • 2.2Purification, modification and labeling of antibody

    Purification: Protein A, Ammonium Sulfate Fraction, ion-exchange chromatography)

    Preparation of fragment; F(ab')2 and Fab'

    Preparation of labeled antibody; HRP, ALP, FITC