Complete analytical package
Efficient labprocess and expert advise
Anabiotec provides a complete package of pharmaceutical testing. For microbiology, analyses are performed internally or in a specialized contract laboratory. Our skilled project managers interpret the results. This leads to an integrated approach combining all analytical testing performed on your molecule or drug product. A complete array of microbiology services for all phases in drug development is available. Some of them are discussed below. At Anabiotec, all tests are developed according to the current edition of the European or United States Pharmacopoeia.
Do your samples need to be analyzed for the presence of microorganisms in general and/or specific pathogenic microorganisms? Your method is validated during the development process. During release of your pharmaceutical product, the microbial purity is evaluated according to the most recent specifications. In stability testing, the amount of microorganisms in your product is monitored. Our project managers suggest actions for preserving the microbial integrity of your new drug.
Anabiotec performs preservative efficacy testing (challenge test) of different formulations for which the antimicrobial efficacy of the product or the preservatives is required. The ability of the product to eliminate or inhibit specific test microorganisms over a period of 28 days is tested. Our aim is to test whether your product is safe to use without risk of contamination for the full product life once the packaging has been opened.
A sterility test is ‘a test that critically assesses whether a sterilized pharmaceutical product is free from contaminating microorganisms’.
The need to provide adequate and reliable sterility test data is an important quality control issue. Sterility testing is a skilled process that must be performed by trained and qualified laboratory personnel. Specific isolators are available to meet the technical demand of sterility testing.
Endotoxin testing (LAL test)
Endotoxins (lipopolysaccharides) are the most common cause of toxic reactions resulting from contamination of drugs with pyrogens. Therefore, endotoxin testing is a key analysis in quality control of products which are administered intravenously or intrathecally.These endotoxins (lipopolysaccharides) from gram-negative bacteria can be detected in very low concentrations (down to 0.4 international units of endotoxin per millilitre by the very sensitive LAL test (Limulus amoebocyte lysate test). In this test, the reaction of the LAL with the endotoxins can be monitored by gel formation, turbidimetric or chromogenic changes.