The Paul-Ehrlich-Institut was founded on 1st June 1896 as Institut für Serumforschung und Serumprüfung (Institute for Serum Research and Serum Testing) at Steglitz near Berlin as a test and research institution. Its name, which it still bears today, was derived from its first director, Paul Ehrlich. His mission was to develop and implement the basic principles of state control of medicines. This mission was initiated against the background of the strongly fluctuating quality and efficacy of the new therapeutic diphtheria anti-serum developed by Emil von Behring.
Thus, the basis for the work done by today’s Paul-Ehrlich-Institut, and the criteria for testing the quality, efficacy and safety of medicines originate from the work by Paul Ehrlich and his co-workers. Paul Ehrlich himself developed the standard for evaluating serum products. This work was especially emphasised by the Nobel Prize committee, when they justified the award of the Nobel Prize for medicine to Paul Ehrlich in 1908.
Together with a handful of co-workers, Paul Ehrlich worked in a rather confined space in a former baker’s shop, first on testing therapeutic diphtheria anti-serum. The institute received between ten and 60 samples to be tested per month.
Today, the employees of the PEI test roughly 9,000 batches annually, and the number of approvals and extensions is approximatly between 400-500 per year.
The tasks of the institute at Steglitz were soon extended. New products, e.g. therapeutic tetanus anti-serum, were added. The institute soon ran out of space.
In addition, Farbwerke Hoechst at Frankfurt am Main, the manufacturer of the therapeutic anti-sera sent clear signals indicating that it wished to have the institute transferred to its vicinity . The mayor of Frankfurt, Dr. Franz Adickes, too, spoke out strongly in favour of the move since he intended to have as many research institutes as possible in Frankfurt that were to act as driving forces for building up a university.
Thus, the institute moved to Frankfurt in 1899 and was to become the newly opened "Königliches Institut für experimentelle Therapie" (Royal Institute for Experimental Therapy). This institute had three groups of tasks, corresponding to its three departments:
- Official testing of all therapeutic antisera subject to state control
- Work in the areas of hygiene and bacteriology for public hygiene of the city, hospitals and physicians of Frankfurt.
- Development of the subject of immunology, especially serum research towards the theoretical branch.
In 1901, a fourth department was added. A department for cancer research could be created with the help of a state contribution and funds from private foundations.
Paul Ehrlich devoted himself to research with his heart and soul. Thus, it was invaluable in his view that Franziska Speyer created a foundation that could be used to build a research institute, the "Chemotherapeutisches Forschungsinstitut Georg-Speyer-Haus".
She inherited the funds for financing the institute from her husband, the banker Georg Speyer, who died of cancer at the age of 67. It was her brother-in-law, Professor Ludwig Darmstaedter, who encouraged her to create this foundation. The new institute was build directly next to the Royal Institute.
The veterinary department was created in 1911. Its official functions were to carry out the state tests of swine erysipelas antisera, fowl cholera anti-sera and swine erysipelas adsorbate vaccines. This kind of compulsory testing was extended more and more during the years that followed.
It was not until 1917, two years after the death of Paul Ehrlich, that Wilhelm Kolle was appointed director of both institutes. In 1921, he had a "middle section" built which was designed to connect the Royal Institute and the Georg-Speyer-Haus.
The two institutes, too were very largely affected by the Hitler Regime. In 1935, e.g. all Jewish employees had to be given notice to leave their jobs, including Wilhelm Caspari, the head of the cancer research department. At the beginning of World War II, the scientific work then stopped entirely, since many of the remaining employees were drafted for military service.
Meanwhile after the death of Wilhelm Kolle, in 1935, Richard Otto had been appointed director. He had all writings by Paul Ehrlich removed from the library of the institute in an attempt to eradicate the name of his first director.
In 1944 the institute was hit by a bomb and badly damaged, so that the necessary testing work could no longer be carried out in Frankfurt. The institute was partly moved to Marburg. The name was changed to "Staatliches Institut für Experimentelle Therapie" (State Institute for Experimental Therapy).
In 1947, Günther K. Schwerin, a grandson of Paul Ehrlich, was granted approval by the military administration and the competent government bodies for giving the institute the name of its first director: "Paul-Ehrlich-Institut - Staatliche Anstalt für Experimentelle Therapie" (State Institution for Experimental Therapy) for the first time in history.
In 1949, Richard Prigge became the successor of Richard Otto and managed the reconstruction of the institute and construction of the extensions for the newly developed poliomyelitis vaccines. When he retired in 1962, Günther Heymann for the first time became acting director of the two institutes. Four years later, the nobel prize winner Niels Kaj Jerne was appointed director of the institute. However, he left Frankfurt soon afterwards to become the director of the Institue of Immunology at Basle. Thus, a new acting director was appointed, Günther Heymann.
During this period, with the "Law Establishing a Senior Federal Authority for Sera and Vaccines", the Paul-Ehrlich-Institut became an independent senior federal authority. Up to that point, the PEI had been a Hessian authority which had taken over the testing of vaccines for the länder as a service. From that point onward, the official marketing authorisation and batch testing of (immuno)biological medicines such as vaccines and sera to be marketed in Germany ranked among the duties of the PEI as senior federal authority.
In 1974, Hans Dieter Brede was appointed President of the Paul-Ehrlich-Institut. In 1986, Mr. Brede retired from this task, after reaching the legal retirement age. While he was still in office, the construction of a new, larger and extremely modern institute was started at Langen, between Frankfurt and Darmstadt.
Prof. Reinhard Kurth became Mr. Brede’s successor. The completion of the new building complex occurred during the first year of Prof. Kurth’s period in office. In 1987 a part of the staff moved from Frankfurt to Langen. However, the official move could only take place two years later.
The opening ceremony of the PEI took place in May 1990. This was an important event, not only for the institute but also for the city of Langen, where internationally recognised scientists met, in order to celebrate the move with a symposium.
At that time, the PEI had five specialised divisions: Division 5 ‚Allergology and Immunopharmacology’ was founded in 1981. Since the early 90s, this division has been called just Allergology. The duties of the institute had grown, but also its good reputation as an institute with competent staff and experts who guarantee the safety of the medicinal products for which they were responsible. In 1992, a sixth division was added: The division of ’Medical Biotechnology’. With the foundation of this division, the institute adjusted itself to the expected growing number of recombinant medicines, to developments in gene therapy, and the research required and important for these areas, e.g. in an attempt to find safe vectors for gene therapy.
It was only four years later that the PEI faced a new, responsible challenge. After the experience gained from the AIDS blood scandal, it was clear that blood and blood derivatives, just as other biologicals, required to be subjected to a more intensive examination and control than this would have been possible at the Bundesgesundheitsamt (Federal Health Office). The experimental testing of products during their marketing authorisation procedure and batch testing are original tasks of the Paul-Ehrlich-Institut. In addition, the institute enjoys an excellent international reputation regarding the quality and relevance of its evaluations. The responsibility for blood and blood derivatives was transferred by law from the former Federal Health Office to the Paul-Ehrlich-Institut.
Since 1995, this responsibility has been in the hands of the Division of “Haematology and Transfusion Medicine” especially created for this purpose. Batch testing was introduced for these products step by step. As of 1st January 1996, all blood derivates are subject to compulsory offcial batch testing.
In June 1996, the institute celebrated its one-hundredth anniversary, which was remembered in September with a scientific conference and other festivities.
In November 1999, Prof. Reinhard Kurth left the PEI, after acting as the head of the Robert Koch Institut at Berlin and the PEI simultaneaously, in order to devote himself fully to the task of director of the Robert Koch Institut from then on. Prof. Johannes Löwer was appointed acting director of the PEI. Up until then, he was the deputy director of the president.
In July 2000 the Paul-Ehrlich-Institut was assessed by the Wissenschaftsrat (scientific advisory body of the German federal government). The Wissenschaftsrat emphasised that the institute had not only clearly improved its image in the past years but also held an outstanding position in its area of responsibilities at a national and international level. According to the view of the Wissenschaftsrat, experimental research at the Paul-Ehrlich-Institut contributed to its convincing competence.
In November 2000, a testing laboratory at the PEI (PEI-IVD) was accredited by the 'Zentralstelle der Länder für Gesundheitsschutz bei den Arzneimitteln und Medizinprodukten' (ZLG) (Central Authority of the Länder (German states) for Health Protection Regarding Medicinal Products and Medical Devices) in accordance with the standard DIN EN 17025 and Directive 98/79/EC. PEI-IVD is an independent professional body that operates on a market oriented bases and collaborates with what is known as ‘Notified Bodies’. These ‘Notified Bodies’ carry out the certification of IVD which, after the coming into force of the so-called IVD-directive (Directive 98/79/EC) will replace the former marketing authorisation. The ‘Notified Bodies’ have the scientific and technical testing performed by testing laboratories such as PEI-IVD. The parameters for testing are laid down in the IVD Directive.
On 7th June 2001, Prof. Johannes Löwer was appointed president of the Paul-Ehrlich-Institut. Johannes Löwer is known in national and international bodies as a competent contact. His expertise is sought after especially in questions concerning viral safety and Transmissible Spongiform Encephalopathies (BSE, CJD, vCJD).
With the appointment of Prof. Dr. Klaus Cichutek as vice President of the institute, filling the vacancies at the management level of the Paul-Ehrlich-Institut could be completed on 31st October 2001. This date also marked the end of the transitional period without regular management of the Paul-Ehrlich-Institut.
In late 2001, the first few laboratories in the ninth and last building complex of the PEI could be initiated. This last building complex was build as an add-on. This last building offers very modern laboratories which, among other things, are required for the work in the fields of AIDS research, xenotransplantation, TSE research, and the safety af blood derivatives.
On 22nd October 2001, the experienced and internationally recognised accreditation body DACH (Deutsche Akkreditierungsstelle Chemie (German Accreditation Body, Chemistry) GmbH) performed an audit at the Paul-Ehrlich-Institut. During this audit, it first evaluated eight methods of the PEI, and then found the Quality System to be compliant with the standards. After receiving the accreditation certificate from DACH in January 2002, the PEI for the first time had an external confirmation of its competence as a test laboratory. Ever since then, the PEI has been entitled to insert the DACH logo in its test reports.
In 2003, the PEI received a first extension of its accreditation in accordance with DIN EN ISO/IEC 17025.
As of 7th December 2003, the Paul-Ehrlich-Institut (PEI) started a new era in the field of testing
"in vitro diagnostic medical devices" (IVD; these tests include e.g. the determination of pathogens such as HIV and Hepatitis viruses). As from this day, the PEI finally stopped being a national licensing authority for IVD, since testing these products must now be exclusively in compliance with the IVD Directive (98/79/EC) which applies throughout the EU. For more than 25 years, the marketing authorisation and official batch control of particular in vitro diagnostic medical devices ranked among the legal duties of the Paul-Ehrlich-Institut in accordance with the Gernan Medicinal Products Act.
During this period, the Paul-Ehrlich-Institut became established as a leading institute in the field at an international level. With the establishment of a free-market oriented test laboratory for iin vitro diagnostic medical devices (PEI-IVD) the PEI succeeded in making its competence available for the evaluation of these important products in future, too. PEI-IVD was accredited by the 'Zentralstelle der Länder für Gesundheitsschutz bei den Arzneimitteln und Medizinprodukten' (ZLG) (Central Authority of the ‘Länder’ (German states) for Health Protection Regarding Medicinal Products and Medical Devices) in accordance with the standard DIN EN 17025 and Directive 98/79/EC as early as the year 2000.
The 14th March 2004 marks the 150 anniversary of Paul Ehrlich, the institute’s first director after whom it was named. On this occasion, the PEI, together with the Paul-Ehrlich Society, the Georg-Speyer House at Frankfurt/Main, the Section of Medicine of the Johann-Wolfgang-Goethe University of Frankfurt/Main and the Paul-Ehrlich Foundation held symposium entitled 'Combating Pathogens and Cancer' to which we were able to invite various internationally recognised scientists as speakers.
The twelfth amendment of the German Medicinal Products Act (Arzneimittelgesetz AMG) on 6 August 2004 conferred the responsibility for gene transfer medicinal products, somatic cell therapies, and xenogenic cell therapies on the Paul-Ehrlich-Institut. In addition, changes have been made regarding clinical studies on medicinal products within the area of responsibility of the Paul-Ehrlich-Institut. Submission of such studies alone is no longer sufficient. They require approval by the PEI.
In June 2005, the Paul-Ehrlich-Institut was appointed the co-operation centre for the quality assurance of blood products and in vitro diagnostic medicinal products by the World Health Organisation (WHO). This appointment is valid for a period of four years. Duties of Paul-Ehrlich-Institut shall include supporting WHO training and conferences relating to blood products and in vitro diagnostic medicinal products, organising, performing laboratory studies and standardisations and assisting in the preparation of guidelines and recommendations.
After reaching the statutory retirement age on 30 November 2009, Prof. Löwer left the Paul-Ehrlich-Institut. Prof. Klaus Cichutek took over the management of the institute as the new president as per 1 December 2009.