Since the beginning of February, Konrad has been strengthening our team in Lörrach as a Senior Consultant and Qualified Person.

Following his PhD in Biology from the University of Hohenheim in Stuttgart, Konrad has continuously expanded his expertise in pharmaceutical production and safety.

Konrad brings extensive experience from over five years at Catalent Pharma Solutions, starting with the primary responsibility for the review and release of master manufacturing instructions from both technical and GMP perspectives. He initially took on project leadership for genetic engineering work and later served as the officer for biological safety. After moving to the Quality Assurance department, he provided QP support in the certification of clinical trial materials. Most recently, as a Qualified Person, he managed comprehensive projects related to clinical studies before joining us.

The PharmaKorell team is excited to have Konrad on board and looks forward to a successful collaboration.

We are pleased to announce that PharmaKorell will be present at CPHI in Shanghai from 24 to 26 June 2025. Our managing directors, Frank Wienen and Ulrich Korell, will personally be there, offering you the opportunity to speak directly with key decision-makers.

Take advantage of this opportunity to learn more about successful EU import processes, GMP certifications, and QP declarations.

We are already starting our preparations for the trip. Immediately after CPHI, we will be conducting GMP audits and other in-person engagements in China. Please contact us via email at info@pharmakorell.com to schedule an appointment.

We look forward to assisting you with your entry into the EU!

In our interview with Dr Benedikt Ball, Senior Consultant and Qualified Person at PharmaKorell in Munich, you’ll discover how we combine the flexibility of a medium-sized company with the comprehensive employer benefits of a large corporation.

Our team in Munich is involved in exciting projects with leading pharmaceutical companies and innovative start-ups. As a growing company, we regularly have open positions for qualified employees. Feel free to send us your resume if you can envision becoming part of our team.

How many employees are currently working in the Munich office and what are the spatial arrangements there? 

The Munich office has two smaller offices and one larger office, a large meeting room, and a kitchen with a lounge area. Currently, four colleagues work in the Munich office. A fifth colleague, whom we selected together, will start in April. We can comfortably accommodate up to 10 team members in our offices in Munich.

Could you explain how PharmaKorell, compared to large corporations, designs work-life balance and what specific measures are taken to flexibly support employees’ needs? 

The working hours at PharmaKorell correspond to the usual office hours. The start and end of working hours are determined by the employees themselves, taking into account customer availability. This allows everyone to consider, for example, the traffic situation in a big city when commuting. With this flexible arrangement, each of us can also make the best use of public transport connections. Remote working is also possible, so commuting times can be completely eliminated on some days. A weekly hour quota is agreed upon for part-time staff. Each consultant sets their own working hours. No more than the contractual working hours are expected per day. If more time is needed for a client on a particular day, the overtime can be flexibly compensated in the following days without the need for approval.

How is working on global projects at PharmaKorell structured, and what development opportunities does this provide? 

Our clients at PharmaKorell are very diverse. Our management ensures that staff participate in both national and international client projects. In most cases, experts in manufacturing and quality control are needed, so at least two colleagues work together. For larger tasks, such as setting up a QM system, additional experts are involved. Particularly in the handling of development projects, good knowledge and broad experience as a QP are highly desirable. Yet, each project has its own individual questions, so even long-serving QPs continuously encounter new challenges and expand their horizons.

What influence does the Munich location have on the working methods and projects at PharmaKorell, and what specific advantages does this offer for QPs? 

Numerous pharmaceutical companies are located in and around Munich. This provides very interesting project opportunities for the colleagues from the Munich office. I myself will be working for three companies in the vicinity in 2025. The proximity allows us to attend appointments on short notice. And for QP activities, it may still be necessary to perform the certification of batches on the company premises.

How does the direct collaboration with the founder of PharmaKorell affect the company culture and decision-making processes, and what advantages does this offer specifically for Qualified Persons (QPs)? 

Given the size of PharmaKorell, there are basically no protracted decision-making processes across multiple hierarchical levels. Immediate questions can be discussed with one of the two managing directors either by phone, Teams, or during their regular monthly visits on site and usually decided then and there. All arguments are heard and taken into consideration in the decision-making process. I always find these discussions very appreciative and on equal footing. As mentioned before, even for long-serving QPs, new issues continually arise, where an exchange of thoughts is very helpful.

Today, we introduce you to Monika Kaur Wagner, who has recently joined us as the Deputy Head of Quality Assurance. Monika brings extensive experience in the pharmaceutical industry and will also take on the role of Head of Quality Assurance and Deputy Head of Production starting April 2025. In this post, we explore her professional background and her objectives at PharmaKorell.

What is your current position at PharmaKorell, and what are the next steps in your career? 

Until March 2025, I am the Deputy Head of Quality Assurance and work as a consultant. From April 2025, I will take over as the Head of Quality Assurance and additionally become the Deputy Head of Production.

At which PharmaKorell location do you work? 

My workplace is located in Lörrach, a charming town at the foot of the Black Forest and directly on the border with Switzerland. However, in my role as Head of Quality Assurance and Manufacturing, I am responsible for both locations – Lörrach and Munich.

What piece of advice have you received during your career that has particularly stayed with you? 

One of the life-changing pieces of advice I received was from Hermann Hesse: “One must attempt the impossible in order to achieve the possible.” This thought motivates me daily to find creative solutions and explore new paths in my work.

What are the highlights of your career so far that have particularly shaped you? 

I have had the privilege of working in various company sizes, from medium-sized businesses like Losan Pharma to global corporations like Pfizer. These experiences have given me a broad perspective on the industry. I have been active in diverse roles, from specialised expert positions to leadership roles with extensive employee responsibility. My activities have spanned multiple departments, including quality assurance, production, and validation. This has helped me develop a deep understanding of the entire product lifecycle in the pharmaceutical industry.

Which aspects of your role at PharmaKorell are you particularly looking forward to? 

I am looking forward to the exciting and challenging, and above all, responsible role as initially Deputy Head of Quality Assurance and from April as Head of Quality Assurance and Deputy Head of Production. I am also excited to work with my new colleagues and get to know them better.

Until a few years ago, the rabbit pyrogen test was a common method to assess the pyrogenic (fever-inducing) effects of pharmaceuticals and medical devices. This test involved injecting rabbits with a sample of the medication to observe whether a fever developed, indicating the presence of pyrogenic substances. However, this test was associated with ethical concerns as it caused pain to the animals and compromised their welfare.

Since the 2000s, the pyrogen test is increasingly being replaced by the Monocyte Activation Test (MAT). The MAT is an animal-free method that relies on human monocytes, which are a type of white blood cell. These cells react to pyrogenic substances by releasing specific inflammatory markers that can be detected using modern testing methods.

The MAT offers several advantages:

• Animal-free: It does not require animals, representing an ethical improvement.
• Safety: Since human cells are used, the test is closer to the actual human body’s response than the rabbit test.
• Reliability: The MAT has proven to be at least as reliable as the traditional rabbit test in identifying pyrogenic substances.

The introduction of the MAT and similar animal-free methods marks a significant advancement in medical research and the development of pharmaceuticals as it respects animal welfare while maintaining the biological safety standards for drugs and medical products.

The European Pharmacopoeia Replaces the Pyrogen Test with the MAT

As part of ongoing efforts to reduce animal testing and improve ethical standards in medical research, the European Pharmacopoeia has taken a significant step: the traditional rabbit pyrogen test will be replaced by the Monocyte Activation Test (MAT) from July 2025. From this date, Monograph 5.1.13 “Pyrogenicity” together with Monograph 2.6.30 “Monocyte Activation Test” in the European Pharmacopoeia will mandate the use of the MAT for pyrogen testing. The Monocyte Activation Test (MAT) can detect both endotoxins and non-endotoxin pyrogens in vitro and must be validated for each specific product.

Manufacturers of pharmaceuticals and medical devices must now prepare to adopt the MAT as the standard method for determining pyrogenicity, which is a crucial contribution to reducing animal testing and promoting alternative testing methods.

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Dr Wanninger is a licensed pharmacist and has worked for over 25 years in state pharmaceutical supervision as a GMP, GDP, and GCP inspector, and most recently for 16 years as the Head of the Inspectorate at the Government of Upper Bavaria. She has extensive experience in regulatory affairs related to pharmaceutical and medical device law, as well as in conducting third-country inspections on behalf of the EMA.

She was a member of several expert groups within the ZLG (Central Authority of the  Laender for Health Protection) and contributed to international procedures of the European Commission. Additionally, Dr Wanninger has participated in several pharmaceutical projects with gtz/giz and PTB in Asia and Africa.

Since February 2023, Dr Wanninger has been working as a Senior Consultant and Lead Auditor at PharmaKorell.

As a globally operating consultancy and certification firm, we continuously monitor pharmaceutical innovations and trends worldwide and enjoy networking within our industry. Next year, we will be participating in the following international events, among others:

Making Pharmaceuticals in Coventry: 29th – 30th April 2025
Swiss Biotech Day in Basel: 5th – 6th May 2025
CPHI China in Shanghai: 24th – 26th June 2025
MabDesign in Lyon: 22nd – 23rd September 2025
Festival of Biologics in Basel: 30th September – 2nd October 2025
CPHI in Frankfurt: 28th – 30th October 2025

What’s on your trade show agenda for 2025? We are always open to further suggestions. We look forward to possibly meeting you at one or more of these events.

We were delighted to host Lunan Pharma in Lörrach. Lunan Pharma is establishing a presence in the EU and submitting authorisation applications for generic medicines. PharmaKorell is advising Lunan on their move to Europe and is pleased that Lunan Pharma has chosen the PharmaKorell address in Lörrach for their EU subsidiary. We congratulate the new company, Lunan Pharma Europe GmbH, on its registration in the commercial register and wish it continued success.

We wish all our business partners a joyful Advent and Christmas season and good fortune and health for 2025. Our team will be taking a break from 24 Dec to 1 Jan. In case of emergencies, we can be reached at the agreed contact details.

Sarah Baier has been enriching our team since this month as the Team Assistant & IT Officer. With extensive experience from her tenure at a leading global company in the industry, where she was involved in the management of humanoid robots and participated in international IT projects, Sarah brings valuable expertise to us. Her motto is: “When the wind of change blows, some build walls, while others build windmills.” We look forward to a successful collaboration!

Congratulations to Runge Pharma on the completion of the new, large office and warehouse building in Lörrach, right next to our office. The photo was taken from the window of the PharmaKorell building.

With over 30 years of experience, Runge Pharma is one of the leading specialists in the procurement of international pharmaceuticals, reference products, and pharmacy-standard goods.

For the past four years, we have been supporting Runge Pharma with GMP projects and quality assurance. We value this trusted partnership and look forward to continued successful collaboration.