Immunoassay Services

Ensure the safety and efficacy of your protein therapeutics with a trusted partner that has the expertise to set up and run the right panel of tests. Whether you're developing novel biotherapeutics or biosimilars, Midwest BioResearch delivers total peace of mind.

Our expert team will design and execute a comprehensive immunogenicity testing program while providing regular updates to keep you completely involved.

We understand the dynamics of the regulatory environment and always maintain the flexibility to adapt to changing requirements. We can even provide training and consultation to help you develop your own procedures and analytical methods to support the current performance expectations.

Immunoassay Quantitative Determination

Ensure your molecule will deliver full therapeutic value with our broad range of trusted analytical methods for new or follow-on biologics. Our industry leading experts will guide you through the process swiftly and cost-effectively.

Pharmacokinetics Panel

• ELISA:
• colorimetric
• fluorescence
• chemiluminescence
• electrochemiluminescence
• Enzyme rate reactions
• Competitive immunoassays

Immunogenicity Safety

Reliably assess possible immune response—including allergic reactions, anaphylactic reactions or induction of autoimmunity—with a comprehensive testing program designed to fit your large molecule, and your milestones.

Our cascade of tests runs from antibody screening through sophisticated assays for measuring neutralizing antibodies—either in cell-based or ligand binding models.

Immunogenicity Panel

• Screening assays
• Confirmatory assays
• Titer measurement
• Epitope mapping
• Neutralizing antibodies

Biosimilars Expertise

Biogenerics and biosimilars offer an important alternative for patients who become antibody positive and stop responding to the originator drug. Midwest BioResearch can help you deliver important therapies by establishing bioequivalency and testing for immunogenicity.

Members of our staff have helped develop regulations in this area and are ideally qualified to guide you through the testing program you need.

Bioequivalency

Protein folding, aggregate formation and glycosylation can all affect the efficacy of your molecule. Let MBR help you develop antibody reagents that recognize your biologic and the originator in the same way, to establish a closer measure of bioequivalency.

Immunogenicity

Ensure the safety of your follow-on biologic with assays that can detect effects that may be due to the slightest presence of impurities, degraded proteins or aggregates.