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Paul-Ehrlich-Institut


The Paul Ehrlich Institute was established as the Institute for Sera Research and Serum Testing on June 1, 1896 in Steglitz near Berlin.

Its first director was Paul Ehrlich, after whom today’s institute is named. After developing a method for the experimental determination of the valency of the new diphtheria serum that had been discovered by Emil Behring, the government assigned Paul Ehrlich the task of examining the individual batches of this serum in order to reduce the sharp fluctuations in its quality and efficacy that had hitherto been observed. The principles underlying the work of the modern Paul Ehrlich Institute and the criteria for verifying efficacy, quality and safety can be traced back to Paul Ehrlich and his staff. Paul Ehrlich worked with a handful of staff members in very cramped conditions in a former bakery. At first they were only concerned with testing diphtheria immune sera, with between 10 and 60 test samples being received by the institute each month. Today the employees of the Paul Ehrlich Institute deal with approximately 9,000 batches annually and the number of applications for (and renewals of) marketing approvals ranges between 400 and 500 per year.

In 1899 the institute was relocated to Frankfurt at the newly established Royal Institute of Experimental Therapy.

The responsibilities of the institute in the fields of testing and research were steadily expanded during the decades that followed. The "Bacteriology" and "Virology" divisions and a division for the development of immunology were created. In 1911 the "Veterinary Medicine" division was added, dealing with vaccines and sera for veterinary use.

On November 1, 1972 the Paul Ehrlich Institute became an independent senior federal authority as a result of the "Act on the Establishment of a Federal Agency for Sera and Vaccines". The institute is the competent authority in Germany for the granting of marketing approvals and batch control of (immuno-) biological drugs, such as vaccines and sera for human and veterinary use as well as blood and blood preparations which are to be brought on to the German market. Another task of the institute is the field of test-related research. In 1981 the "Allergology" division was founded, followed in 1992 by the "Medical Biotechnology" division. The establishment of the "Medical Biotechnology" division prepared the institute for meeting the expected increasing number of recombinant drugs, developments in gene therapy and the important research needed in these fields, such as the search for safe gene ferries for gene therapy.

In 1994 the Paul Ehrlich Institute was assigned a new, extremely important task. The blood AIDS scandal clearly revealed the necessity of submitting blood and drugs made from it to rigorous experimental inspection and control in exactly the same way as other biological drugs. Responsibility for blood and blood preparations lies with the "Hematology and Transfusion Medicine" division, which was established in 1995. The legal obligation of batch control was introduced in stages and since January 1, 1996 all blood preparations have been subject to obligatory batch control by the Paul Ehrlich Institute as the competent federal authority.

In short, the present-day duties of the Paul Ehrlich Institute are the granting of marketing approvals and the batch control of (immuno-)biological and hematological drugs as well as research in these fields.

Other responsibilities of the Paul Ehrlich Institute are:

  • Monitoring of drug risks of drugs for which the institute is responsible

  • Involvement in the granting of marketing approvals to scientific field tests of immunological drugs for veterinary use

  • Involvement in the granting of marketing approvals for "hi-tech" drugs under the licensing procedures of the European Community

  • Cooperation in international bodies such as the World Health Organization (WHO) and in human and veterinary drugs committees of the European Community

  • Finally, the institute acts in an advisory capacity for the German Federal Government and other government bodies.

The Paul Ehrlich Institute has seven specialist divisions: Allergology, Bacteriology, Hematology and Transfusion Medicine, Immunology, Medical Biotechnology, Veterinary Medicine and Virology. Additionally, there are divisions for Administration and for General Services. The latter includes the sections "Pharmacovigilance", "Legal Department" and "Press and Public Relations". The institute has a yearly budget of roundabout 50 million Euro for fulfilling its duties in the field of drug safety. The Paul Ehrlich Institute has a total of some 570 staff members, 350 of whom have permanent positions and many of the remaining jobs are financed by third parties.

Research also plays a major role in the Paul Ehrlich Institute’s work. In July 2000, the Paul Ehrlich Institute was appraised by the Scientific Counsel of the German Federal Government. The Scientific Counsel stressed that the Institute has not only gained considerably in reputation during the last few years, but also occupies a prominent position nationally and internationally in its field of work. In the opinion of the Scientific Council, experimental research at the Paul Ehrlich Institute makes a major contribution to its proven competence.

Research at the Paul Ehrlich Institute focuses on five key areas:

  1. Infection biology and vaccines

  2. Methods for the replacement of animal experiments

  3. Drugs made from blood

  4. Molecular immunology and molecular allergology

  5. Biotechnological drugs



 

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