Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Worldwide Regulatory Strategy for the Development and Submission of a Recombinant Product antagonizing the Action of a Medicinal Product ***

Dr. Matthias Hübner (Abschlußjahr: 2012)

Language: English

Therapeutic substances can be highly effective and induce a strong therapeutic response in the human body. The other side of the coin is that a strong therapeutic effect is frequently linked to likewise strong adverse reactions – particularly if for whatever reason it comes to an overexposure to the therapeutic substance.

Serious overexposures can be treated or prevented by use of an antidote. In the past, antidotes have in some cases been discovered by accidence or sometimes because treating physicians were looking for ways to antagonize severe overexposures caused by a therapeutic substance. Nowadays, depending on the safety profile of the target, development of antidotes may already become part of risk mitigation strategies for new therapeutic substances. The progress of science has opened up new opportunities to utilize monoclonal antibodies for highly specific binding to therapeutic substances. Such binding is capable of deactivating any desired or undesired effect so that also severe adverse reactions from the targeted substance can be suppressed. Antidotes of the Fab-type have proven to be very useful and highly specific antidotes for therapeutic substances while showing very little tendency for physiological interaction themselves – thereby implicating a low risk to cause adverse reactions.

This master thesis outlines the development of an antidote of the Fab-type under pertinent guidances and discusses regulatory approaches to achieve marketing authorisation.