Welcome to the Frankfurt Foundation Quality of Medicines

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Every day, medicinal products make a decisive contribution to prevent diseases – especially serious ones – or alleviating ailments, extending the life expectancy of patients and improving their quality of life. In addition to our high expectations of the efficacy and safety of medicines, the pharmaceutical quality of the products is also particularly important with regard to patient care.

The Frankfurt Foundation Quality of Medicines (FFQM) is committed to promoting research activities that are designated to optimally assure the quality of medicinal products in Germany and Europe or, if necessary, further improving them, especially if they are manufactured outside the country. Main concern is the development of advanced processes, the implementation of innovative technologies and their standardization as well as a critical verification of quality assurance concepts.

Download the FFQM flyer here (PDF-File, ~200kB)

Recent news

June 21, 2024 · Funding Projekts

Project funding for the development of a method for quality assurance of biopharmaceuticals using undirected protein profiling

The detection and characterization of unknown and/or unexpected impurities is a key element in most of the FFQM-funded projects so far. The aim of the current project is to develop such methods for biopharmaceuticals. The developed procedures should allow a simultaneous determination of the active pharmaceutical ingredient of these protein containing medicinal products as well as their possible degradation products and impurities. Moreover, potential counterfeits of these preparations should also be detected. In contrast to most of the conventional analytical procedures used for quality control of biopharmaceuticals, methods should be developed in this project for non-directional protein profiling.

Supervisor of the project is Professor Monika Pischetsrieder, University of Erlangen-Nuremberg, Department of Chemistry and Pharmacy, Chair of Food Chemistry. Her research team has already gained extensive experience in corresponding analytical issues on the food sector. Current research interest is now to extent this expertise to the field of medicinal products by testing how far suitable methods can be transferred and/or adapted to the field of biopharmaceuticals.

This research project is of great practical pharmaceutical relevance, as the detection and identification of degradation products or impurities should help to optimize quality control of the corresponding protein drugs

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April 25, 2024 · Funding Projekts

Follow-up publication to the FFQM funded project "Detection of unexpected impurities in finished medicinal products."

The working group of Prof. Oliver Scherf-Clavel, Ludwig Maximilian University of Munich, has published a further study on impurities in Lorsatan tablets. The results were recently published in the Journal of Pharmaceutical and Biomedical Analysis: Backer et al „Targeted and untargeted screening for impurities in losartan tablets marketed in Germany by means of liquid chromatography/high resolution mass spectrometry“, https://doi.org/10.1016/j.jpba.2024.116160.

In the present study, the LC-MS/HRMS approach described by Backer et al. for the analysis of known and unknown losartan potassium impurities (https://doi.org/10.1016/j.jpba.2023.115955) was applied to an even more complex system in a larger screening context. The present study included 35 losartan drug products and fixed dose combination products purchased in German pharmacies in 2018 and 2022. The film-coated tablets were analyzed using four LC-MS/HRMS method variants. Differences in the impurity profiles of medicines from 2018 and 2022 were observed.

This study demonstrates that broad screening approaches such as this are applicable to the analysis of pharmaceuticals and can contribute to an important improvement in the quality assurance of medicinal products.

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April 17, 2024 · Prices and Awards

Pearls of Bioequivalence Award 2024 goes to Prof. James Polli

We congratulate Professor James E. Polli, Department of Pharmaceutical Sciences, University of Maryland, School of Pharmacy, who is this year’s winner of the Pearls of Bioequivalence Award. The prize is awarded jointly by the Frankfurt Foundation Quality of Medicines (FFQM) and the European Federation for Pharmaceutical Sciences (EUFEPS). The award goes to the publication of Prof. Polli:

“Lack of an Effect of Polysorbate 80 on Intestinal Drug Permeability“, Pharmaceutical Research (2022) 39:1881–1890 https://doi.org/10.1007/s11095-022-03312-zis

This prize was awarded at the Global Bioequivalence Harmonization Initiative (GBHI) conference on April 16 in Rockville/MD by the Chairman of the foundation’s Board, Professor Henning Blume.

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April 11, 2024 · News

“Medicinal products with pH-dependent solubility - A problem for BA/BE assessment?” FFQM enables Open Access to this ICH M13A commentary.

We are pleased that, following the conference report on the EUFEPS Open Forum on the ICH M13A Draft Guideline (https://doi.org/10.1016/j.ejps.2024.106741), a commentary on the draft guideline „Medicinal products with pH-dependent solubility – A problem for BA/BE assessment? has now also been published in the European Journal of Pharmaceutical Sciences. The FFQM has sponsored open access to the article in order to provide free access to all scientists interested in optimizing drug quality.
The publication can be accessed at
https://doi.org/10.1016/j.ejps.2024.106756

Translated with DeepL.com (free version)

March 17, 2024 · Prices and Awards

Hans-Günter-Schäfer Award 2024

„I hope you will take this award as motivation for your future research as a scientist“. With these words, the Chairman of the Frankfurt Foundation congratulates this year’s winner of the Hans Günter Schäfer Science Award, Ms. Yomna Nassar (Freie Universität Berlin). The prize, endowed with 1,000 euros, is sponsored by the Frankfurt Foundation Quality of Medicines (FFQM).

The award was presented on 15 March on the occasion of the PKPD expert meeting in Isny, which is organized by the Association for Applied Human Pharmacology (AGAH). The past president of the AGAH, Dr. Andreas Kovar, and this year’s chairman of the meeting, Dr. Alexander Staab, present the prize to Yomna Nassar after her summary of the main results of the award-winning publication.

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March 10, 2024 · News

Open Forum on ICH draft Bioequivalence Guideline: Conference Report published

We are happy to announce that the Conference Report of the EUFEPS Open Forum on the ICH draft M13A guideline (Bioequivalence) has been published and the Frankfurt Foundation Quality of Medicines could support this by funding its open access publication.

The paper can be downloaded via: https://doi.org/10.1016/j.ejps.2024.106741

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