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Biological Testing

Determining the absence of endotoxin or pyrogen is compulsory for the quality assessment of sterile dosage forms. Similarly as with pharmaceuticals, the absence of endotoxin is one of the criteria for sterile medical devices. Labor LS offers a wide range of biological purity tests for pharmaceuticals and medical devices. These include, for example, tests for endotoxins, tests for pyrogens and monocyte activation tests (MAT) for the quality control of sterile products. In addition, we determine the biological activity of insulin according to USP <121>.

Our biological testing services further include the AMES test, used for testing for mutagenic properties of substances, and the HET-CAM-Test, for testing for mucosal intolerance of substances or preparations.

Test for Endotoxins (LAL Test)

The Limulus Amebocyte Lysate (LAL) test is the most sensitive and most specifically effective method for the detection of endotoxins.

The Limulus Amebocyte Lysate (LAL) test is the most sensitive and most specifically effective method for the detection of endotoxins. Customers of Labor LS can rely on a broad range of LAL test methods. For instance, we offer our customers a selection of four well-established test methods for product testing: the gel-clot method (method A and B), the kinetic turbidimetric method (method C) and the kinetic chromogenic method (method D). On request, we perform a product-specific matrix validation of the LAL tests for each of the test methods.

Our services in the LAL test include both testing of in-process controls and release tests of pharmaceuticals and medical devices (control unit ANSI/AAMI ST72:2011). The quantitative endotoxin determination by means of our kinetic test methods (methods C and D) gives our customers the most detailed and informative result evaluation.

Furthermore, our “hard spike” analysis offers customers the possibility of testing their products (in particular final products, but also active ingredients as well as raw and packaging materials) for possible product-related endotoxin masking effects. The “hard spike” analysis involves the artificial contamination of an initial test substance or a specimen with endotoxins. Based on the endotoxin value, which is determined from the known contamination value, this method allows to detect product-related endotoxin masking effects. In this way, we can offer our customers the highest level of security in product testing and enable them to rule out potentially false-negative results.

Taking into account a defined product life and storage conditions, the “hard spike” analysis also enables our customers to conduct “hold time” studies, i.e. product life validations, at Labor LS. These studies on the topic of “Low Endotoxin Recovery (LER)” address product safety and define the available analytical time-frame for performing endotoxin tests.

Labor LS looks back on many years of experience also in terms of the qualification of dry heat sterilisers and depyrogenation tunnels. We offer this knowledge as part of our commercially-available test specimens (so-called “challenge vials”) as well as in our customers' individual test specimens contaminated with endotoxins.

New at L+S AG: with the EndoLISA™ test system, Labor LS offers a new possibility for testing for bacteria endotoxins. This ELISA-based test method provides an alternative to the pharmacopoeia methods of the LAL test. Both for product matrices strongly interfering with the LAL test as well as for pharmaceutical formulations, the EndoLISA™ test system offers new possibilities of sample processing. Particularly for the phenomenon of Low Endotoxin Recovery (LER), the EndoLISA™ test design provides new solutions for the product-related masking of endotoxins and for test conditions that enable to rule out potentially false negative results in the context of release analysis. A detailed article on this new test method can be found in our current edition of UpDate (starting on page 5).

Your contact person:

Dr rer nat Enrico Barth 
Graduate Biologist

+49(0)9708/9100-462
enrico.barth@labor-ls.de

Test for Pyrogens

According to Ph Eur 2.6.8 and USP <151>, the pyrogen test is the classic method for testing sterile pharmaceuticals for contamination with pyrogens.

According to Ph Eur 2.6.8 and USP <151>, the pyrogen test is the classic method for testing sterile pharmaceuticals for contamination with pyrogens. In many cases, it has now been replaced by the Limulus Amebocyte Lysate test (LAL test). However, there is a wide variety of products for which the pyrogen test, which cannot yet be safely replaced by any other method, is compulsory and required. This is especially the case where products from blood components need to be examined and where the LAL test does not provide sufficiently meaningful results.

 

For further information and questions, we are happy to answer your questions at +49 (0)9708/9100-280.

Monocyte Activation Test

The monocyte activation test (MAT) was included in the European Pharmacopoeia (Ph Eur) in 2010. It is to detect substances that may have fever-inducing effects on humans.

 

The monocyte activation test (MAT) was included in the European Pharmacopoeia (Ph Eur) in 2010. It is to detect substances that may have fever-inducing effects on humans.

 

Labor LS offers the monocyte activation test as an important complement to the LAL and pyrogen test because it detects not only endotoxins and has a similarly high sensitivity. On this basis, a broader range of preparations can be investigated than with the traditional pyrogen test. However, a product-specific development and validation is a prerequisite for the application of the test.

Your contact person:

Dr rer nat Enrico Barth 
Graduate Biologist

+49(0)9708/9100-462
enrico.barth@labor-ls.de

Test for Abnormal Toxicity/General Safety

To this day, this procedure is an effective method to test for unexpected toxic effects of pharmaceuticals.

To this day, this procedure is an effective method to test for unexpected toxic effects of pharmaceuticals.

 

For further information and questions, we are happy to answer your questions at +49 (0)9708/9100-280.

AMES-Test

The AMES-Test, a bacterial reverse mutation test, is a tool to determine the mutagenic effect of substances, for example in pharmaceutical research or in the risk assessment of chemical substances.

The AMES-Test, a bacterial reverse mutation test, is a tool to determine the mutagenic effect of substances, for example in pharmaceutical research or in the risk assessment of chemical substances. The method is based on bacteria which are no longer able to synthesise essential amino acids. These bacteria are incubated with potential mutagens on a substrate preventing reproduction. If new bacterial colonies occur, it is demonstrated that they have regained the capacity for synthesis.

Labor LS performs AMES-Tests for its customers and also generates all documentation required by the authorities for approval, permission, registration or notification procedures. The tests are conducted according to the requirements of Good Laboratory Practice (GLP).

Your contact person:

Anastasija Schlicht
Graduate Biologist
+49(0)9708/9100-190
anastasija.schlicht@labor-ls.de

HET-CAM-Test

The HET-CAM-Test (hen's egg test on chorioallantoic membrane) is an established alternative to the Draize-test (animal experiment).

The HET-CAM-Test (hen's egg test on chorioallantoic membrane) is an established alternative to the Draize-test (animal experiment).

In Germany the HET-CAM-Test is generally accepted as an official pre-test or screening method for mucous membrane compatibility and may replace the Draize-test in testing highly irritant substances. Labor LS offers the HET-CAM-Test and develops in cooperation with its customers a test design perfectly fitting to their needs.

Your contact person:

Anastasija Schlicht
Graduate Biologist
+49(0)9708/9100-190
anastasija.schlicht@labor-ls.de

Testing for absence of DNases / RNases

We can test your products for absence of DNases or RNases to provide quality assurance for molecular biology materials and reagents, cell culture plastics and media as well as new classes of active pharmaceutical ingredients based on DNA or RNA.

We can test your products for absence of DNases or RNases to provide quality assurance for molecular biology materials (reaction vessels, pipettes, microtiter plates) and reagents, cell culture plastics and media as well as new classes of active pharmaceutical ingredients based on DNA or RNA.

The absence of DNases or RNases in a sample is determined indirectly via qualitative measurement of DNase or RNase activity after addition of DNA or RNA. The samples are evaluated by agarose gel electrophoresis.

 

Your contact person:

Anastasija Schlicht
Graduate Biologist
+49(0)9708/9100-190
anastasija.schlicht@labor-ls.de

Insulin Assay

The USP stipulates qualitative and quantitative biological assays for the determination of the identity and activity of insulin. Insulin products marketed in the United States must, as a rule, comply with these requirements.

The USP stipulates qualitative and quantitative biological assays for the determination of the identity and activity of insulin. Insulin products marketed in the United States must, as a rule, comply with these requirements. The test according to USP <121> was established at Labor LS in 2005 and has been inspected by the FDA.

 

For further information and questions, we are happy to answer your questions at +49 (0)9708/9100-280.

News

LS opts for a future-oriented corporate structure

Press release dated 23 April 2018


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Events

Laborfehler und CAPAs in der Qualitätskontrolle

17./ 18. Oktober 2018, Mannheim (Concept Heidelberg)


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Der GMP Hygienebeauftragte Block 2

17. - 19. Oktober 2018, Leimen (Concept Heidelberg)


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Contact

Labor LS SE & Co. KG

Mangelsfeld 4, 5, 6
97708 Bad Bocklet-
Großenbrach

Fon: +49 (0)9708/9100-0
Fax: +49 (0)9708/9100-36
E-Mail: service@labor-ls.de

Infobox

In our Infobox, we make additional information on our company, our service portfolio and our QM certification available to you in a download. 

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