Range of Services
Assay Development
Assay Validation
Sample Measurement
Protein Purification
Antibody Production
HCP-Assays
Anti Drug Antibody, ADA
Testkits
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Immunogenicity ELISA (Anti Drug Antibody, ADA)
During drug development the main question beside effectiveness is, if the drug induces antibody formation, which may exclude repeated or long-term treatment. Therefore test systems are needed to document or exclude these undesirable immunological side effects.
Requirements for the development of an ELISA:
- Masking of potential epitopes due to conjugate synthesis. At least two different types of conjugates are
needed.
- The assay should be species-independent for the use in humans as well as in laboratory animals.
- Positive antibody results should be confirmed by the addition of the drug to exclude a non-specifity in the test
system.
Means to increase sensitivity
- An improvement of the assay sensitivity is achieved by the use of a mix of two types of conjugate linking sites: N-terminal via cysteine and C-terminal via lysine,
- The use of optimal test conditions (time, temperature, buffer)
Principle of a HS sandwich ELISA
Test characteristics
- Variation of calibration parameters of the 4 parameters logistic (4PL) fit
>li>Accuracy and precision results of standards and QC samples
- Positive and negative controls
- Cut point factor (CPF) determination
- Analyte stability
- Cross reactivity, plate and conjugate interferences
- Confirmation assay
Optional established methods supporting an HS ELISA development
- Assay development, validation, documentation and test kit production
- Technologietransfer und Anpassung des Tests an das Kundenlabor inklusive Training des Laborpersonals.
- Technology transfer and adaptation at a customer lab including training of the responsible persons
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