Immunoassays

In addition to basic ELISA services which covers many of the cytokines and other areas, MDS provides complete custom assay development for the biopharmaceutical and diagnostic industry. MDS can design, validate and manufacture any type of assay to meet the requirements of the researcher. We can validate commercially available cytokine/chemokine ELISA kits, as well as develop novel ELISA for soluble proteins.

TK/PK Sample Analysis:

Where toxicokinetic/pharmacokinetic analysis is required on biologics, these novel types of therapeutics require novel analytical approaches. MDS's expertise includes the use of a range of immunoassay formats (EIA, ELISA, RIA), and of flow cytometry. MDS offers development of assays for measuring levels of biologics that are both specific and sensitive.

Immunogenicity/Antigenicity:

Development of unwanted immunogenicity is a particular issue affecting therapeutic proteins. The development of anti-drug antibodies (ADA) can cause allergic or anaphylactic reactions, reduction in efficacy, and induction of autoimmunity. The risk of these adverse effects increasing is related to the production process, formulation and number of doses administered during the course of treatment. Conversely, in the assessment of efficacy of vaccine products the development of an immune response is the desired result.