Consulting & Drug Reaction Expertise
ADR-AC GmbH – Specialist for drug hypersensitivity reactions.
ADR-AC has longtime expertise in drug hypersensitivity research. In case of adverse drug reactions during pre-clinical stages, phase I – III clinical trials or in post-marketing stages, ADR-AC offers defined risk assessment to analyze and evaluate the immune-stimulatory potential of culprit substances. Our know-how thereby focuses on small chemical molecules as well as on biologicals, e.g. therapeutic proteins and monoclonal antibodies.
Careful evaluation of the reported incidence followed by a scientific feedback regarding the necessity and usefulness of in vitro tests proofing the drug’s immune-stimulatory capacity.
Suggestions of accurately defined in vitro tests matching your relevant questions.
Precise performance of wet-lab experiments followed by their detailed analysis and interpretation, summarized in a final report.
Risk assessment for immune mediated side effects of drugs.
ADR-AC has profound know-how in performing in vitro experiments based on human immune cells. Upon your request ADR-AC will propose a panel of tests designed to reveal the immunogenic potential of your drug. Depending on the question(s) of interest single or multiple tests can be applied.
A major goal for the potential risk assessment of drugs is the early identification of drugs able to cause severe, immune mediated side effects. These studies must rely on human cells, and consider the enormous heterogeneity of the HLA alleles, as certain HLA-allelels are risk alleles for some drugs (e.g. HLA-B*5701 and abacavir).
It is necessary to establish the risk assessment in vitro. To this end, the optimal in vitro conditions of drug stimulation have to be defined, e.g the ideal incubation time of cell cultures and an appropriate read out system for dug specific cells. We are presently optimizing the stimulatory conditions to detect drug specific T cell reactions of drug naive individuals.
Over the last 10 years, we supported and advised many companies and their projects in diverse fields of interest.
Support for general issues in drug hypersensitivity (eg. mechanisms in hepatitis, SJS)
Hoffmann La Roche
Applied Lab Analysis
Support and individualized in vitro testing concerning immunologic issues involving a drug during all stages of drug development.
Johnson & Johnson
Advice on different issues without the involvment of lab work.