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No More Rabbit Pyrogen Testing – Replaced by the MAT

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.

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.


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PharmaKorell Trade Show Planning for 2025

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.

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Lunan Pharma Visiting Lörrach

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.

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We wish a joyful Advent and Christmas season

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.

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Welcome to PharmaKorell, Sarah!

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!

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Congratulations to Runge Pharma on the completion of the new, large office and warehouse building

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.

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Our participation at the Festival of Biologics

Wiebke Hallensleben-Steen and Bastian Fleitz have attended the initial presentations at the Festival of Biologics in Basel and are keen to explore potential synergies and discuss collaboration opportunities in one-on-one meetings. We invite you to seize this opportunity for a professional exchange.

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The CPHI in Milan was a great success for us

The CPHI in Milan was a great success for us, with many good discussions and valuable contacts. It truly is a unique opportunity to connect with a wide variety of exhibitors and industry professionals. We’ll definitely be attending the CPHI 2025 in Frankfurt!
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Our schedule for the Festival of Biologics Event in Basel next week is taking shape

We are particularly looking forward to the following presentations:

Oct 15, 2024
14.40 JJP-1212 Precision Medicine Approach
Louis Boon, JJP Biologics
15.20 Expanding the scope of conjugatable drugs for ADCs carrying payloads with novel modes of action
Marc-André Kasper, Tubulis GmbH
15.40 Effective Strategies for Successful Bispecific Antibody Development and Manufacturing
Sherry Gu, WuXi Biologics
16.50 Innovative Approaches in Cell Line Development: Leveraging Technology and Case Studies for Scalable Process Optimization
Alejandro Infante, Lonza
17.10 Protein Engineering
Ruediger Jankowsky, AATec Medical GmbH
17.30 Driving Cell Therapy Success: Acro’s GMP Solutions for Seamless Manufacturing
Anil Kumar, ACRObiosystems
17.30 Enhanced vector technology for improved expression control of bispecific antibodies
Peter O’Callaghan, Lonza Biologics
17.30 Small Molecule Therapeutics targeting Fibroblast Activation Protein in the tumor microenvironment
Andrea Galbiati, Philochem

Oct 16, 2024
10.30 Keynote Panel Discussion, sponsored by Genedata: Beyond the Hype: Next Steps for AI in Biologics R&D
Jana Hersch, Genedata + Uwe Wittenberg, Merck Healthcare KGaA + Luciano Lucas, Leica Microsystems
14.20 From DNA-encoded Chemical Libraries to radioligand diagnostics and therapeutics against cancer
Sebastian Oehler, Philochem
16.50 Early clinical results of an anti-CD89 antagonist for treating IgA-mediated autoimmune and fibrotic diseases
Louis Boon, JJP Biologics
17.10 First-in-class inhibitors of ERAP1 generate novel cancer antigens as targets for MHC-I-directed therapies
Wayne Paes, Grey Wolf Therapeutics

Oct 17, 2024
9.00 Formulation, Fill/Finish & Supply Chain
Senior Representative, Lonza

For meeting requests, please send us a private message or contact Wiebke Hallensleben-Steen or Bastian Fleitz via the event app.

Headquarter Lörrach

PharmaKorell GmbH
Georges-Köhler-Str. 2
79539 Lörrach
Germany

Tel. +49 7621 949860
info@pharmakorell.com

 

  

We support the work of Pharmacists Without Borders Germany e.V.

 

  

We support the foundation outpatient children hospice Munich.

Branch office Munich

PharmaKorell GmbH
Schleißheimer Str. 373
80935 München
Germany

Tel. +49 89 24883410
info@pharmakorell.com

Contact in Switzerland

PharmaKorell GmbH
Lörracherstrasse 60
4125 Riehen/Basel
Switzerland

Tel. +41 79 1396748
info@pharmakorell.com