Wednesday, 12 May 2010 13:51

“A quantum leap in pyrogen testing” sets a benchmark in advancing animal welfare Featured

A unique patented assay for detecting and quantifying various substances inducing fever (pyrogens), the „PyroDetect System“, simulates human pyrogen-induced fever reactions better than any animal test available on the market. The Europ. Centre for the Validation of Alternative Methods confirmed an easy manageability and the reliability of the assay, which now is introduced into the European Pharmacopoeia in 2010 as an alternative to the rabbit test.

Press release of Biotest AG:

Biotest launches PyroDetect, a revolutionary system for easy and robust testing of a broad range of pyrogens


The PyroDetect System, a unique patented assay for detecting and quantifying various exogenous pyrogens, is based on the Monocyte-Activation Test (MAT) with an Interleukin-1β (IL-1β) response. As it uses human whole blood it simulates human pyrogen-induced fever reactions better than any animal test available on the market. An international validation study coordinated by the European Centre for the Validation of Alternative Methods (ECVAM) found the MAT to be an easy-to-use and reliable test system. As a consequence it was introduced into the European Pharmacopoeia (EP Chapter 2.6.30) in 2010 as an alternative to the rabbit test.

The PyroDetect System covers the same full range of pyrogens as the rabbit test and a much broader spectrum than the Limulus Amebocyte Lysate (LAL) test which detects only endotoxins (lipopolysaccharides in the outer membrane of gram-negative bacteria). In addition to endotoxins the PyroDetect System detects pyrogenic substances from gram-positive bacteria (lipoteichoic acid) as well as pyrogenic particles from molds and yeasts, viruses and even environmental contaminants, such as packaging material. It supports a uniquely broad range of applications in pharmaceuticals, biologicals, medical devices and cell therapeutics.

„The PyroDetect System represents a quantum leap in pyrogen testing and is an outstanding addition to Biotest’s portfolio of innovative test systems for laboratories in the pharmaceutical, medical devices, cosmetics and food industries,” comments Dr Frank Schulze, Executive Vice President Microbiology at Biotest AG. „There are many products that the existing pyrogen tests cannot reliably test. For example, the rabbit test is unsuitable for cytostatic drugs, sedatives, cytokines, antibiotics, chemotherapeutics and proteins, the LAL test for blood, lipids, cell therapeutics and solids. PyroDetect puts an end to these constraints while, at the same time, advancing animal welfare”.

Using the PyroDetect System involves two main steps: incubating the sample in human whole blood and performing the IL-1β ELISA[1]. First the test sample is mixed with the pooled, freeze-stored cryoblood (or, alternatively, fresh blood) and incubated, during which the blood’s monocytes produce IL-1β if the sample contains any pyrogens. For detection the mixture is transferred to a microplate coated with an antibody that specifically binds IL-1β. The subsequent ELISA allows the concentration of the bound IL-1β to be determined. The pyrogen concentration can then be determined using a standard curve.

The PyroDetect System is a human specific, full-fledged substitute for the rabbit test and is ideally suited to complement the LAL test for testing newly approved research products.

Dreieich, 10 May 2010.


Biotest AG, Biotest Mikrobiology
Wernher-von-Braun-Str. 9
D-69214 Eppelheim
www.biotest.de
Dr. Sabine Müller
Tel.: +49 (0) 6221 726 5130
Fax: +49 (0) 6221 726 5139
e-mail: hycon[at]biotest.de

 

 


       Dr. Stefan R.M. Fennrich, Tübingen, who was
decorated with several awards for the
development of the PyroDetect-Assay with the
test-kit.

Photo: Courtesy of Dr. Fennrich.


Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

[1] Editorial note of InVitroJobs: ELISA, Enzyme-linked Immunosorbent Assay, also known as an Enzyme Immunoassay (EIA), is an immunological assay that is based upon an enzymatic colour-reaction.

Please, take notice of our article of Mai 07th 2010: "In-vitro-Pyrogentest schreibt mit Europaweiter Zulassung Geschichte".