We are immensely pleased to contribute to the advancement of innovative biotech medicines, which often require ultra-low-temperature storage at -80°C, by taking on the crucial task of temperature-appropriate storage.

Upon customer request, we have installed multiple ultra-low-temperature freezers in our storage facility within four weeks. These have been qualified and commissioned in accordance with stringent pharmaceutical standards. A backup freezer is available in case of unexpected disruptions. Additionally, the storage facility is secured with an alarm system and an emergency power supply.

It’s important to us to be able to respond flexibly to individual client requirements while simultaneously having the capacity to handle complex projects in a timely manner. At PharmaKorell, we offer the best of both worlds—a multidisciplinary team that brings the competencies of a larger organisation but retains the adaptability and attention to detail expected from smaller companies.

Following the successful completion of auditor training, which comprised an external course and participation in ten GMP audits, we are pleased to announce the promotion of Dr. Matthias Barth to the role of Lead Auditor and Senior Consultant.

Originating from the field of geology, he earned his Doctor of Philosophy (Ph.D.) from the esteemed Harvard University.

Upon completing his studies in the USA, Dr. Barth initially worked in analytics before transitioning into the realm of medical technology (ISO 13485).

Since 2019, Matthias has been a consultant at PharmaKorell GmbH, specialising in quality assurance, quality control, and warehousing/logistics. His promotion underscores his unwavering commitment and professional expertise.

We began the day with a journey to the impressive Vitra Campus in Weil am Rhein. Over a communal breakfast, we fortified ourselves before embarking on a guided tour through the world-class architecture of the campus. Among other things, we had the opportunity to visit the current exhibition, “Garden Futures”, at the Vitra Design Museum and to take a stroll through the garden designed by Piet Oudolf.

Subsequently, we made our way to the Löwen Restaurant in Eimeldingen, where we had time to reflect upon and share our morning experiences.

In the afternoon, at the suggestion of one of our colleagues who volunteers there, we visited the Technical Relief Agency in Lörrach.

We are grateful for a well-spent day amongst colleagues.

As part of #QuestionOfTheMonth, we asked Dr. Rudolph Francke about the most interesting project he has worked on so far as a Senior Consultant and Qualified Person at PharmaKorell. Here is his answer.

“Working at PharmaKorell in the field of pharmaceutical quality management is multifaceted and therefore always very interesting. The collegial environment, consisting of experts from various disciplines, also has a positive impact. This means that colleagues can be efficiently consulted for difficult problems.

The focus of most client projects are the regulatory guidelines and laws dictated by the legislature. For me, a particular client project, which involved a large proportion of professional consultation in addition to ensuring regulatory compliance, was so far the project that I enjoyed the most. This project involved creating a so-called CEP (Certificate of Suitability of Monographs of the European Pharmacopoeia) for a peptide and submitting it to the European Directorate for the Quality of Medicines (EDQM).

The granting of a CEP certifies to the manufacturer that the active substance is sufficiently controlled by the monograph of the Ph. Eur. For the application of a CEP, among other things, the complete validated analytical test methods as well as the complete synthesis path must be submitted.

Assisting the client in compiling the necessary documents for a successful CEP application, ensuring regulatory and technical completeness and accuracy, was a diverse project. The efforts were rewarded when the CEP submission to the EDQM was successfully completed without any objections.”