Bioassay GLP lab testing services

Bioassay GmbH supports high quality development and manufacture of pharmaceuticals, biopharmaceuticals and specialized healthcare products with a range of Good Laboratory Practice (GLP) compliant bioanalytical lab services in Pharmacology and Toxicology.

The Bioassay Analytics Labs possess the expertise and facilities, including High Performance Liquid Chromatography HPLC tools, required to provide a wide range of bioanalytical assays, tests, validation and analysis.

cGLP Testing

It carries out qualified analytics lab services soundly based on GMP & GLP certification, providing a reliable framework for successful projects and routine bioanalysis.

The range of laboratory testing services offered includes standardized bioactivity, safety and toxicity assay formats for chemical and cosmetic products, tests for skin sensitization using Epiderm™ epidermis test method, toxicity and custom-tailored assays for ‘Cosmeceuticals’.

Specific testing regimes covered include:

• OECD 442B Local Lymph Node Assay (LLNA) chemicals
• OECD 442C Direct Peptide Reactivity Assay (DPRA)
• OECD 442D ARE-Nrf2 Luciferase Test Method (KeratinoSens™)
• OECD 442E U937 Cell Line Activation Test (U-SENS™)
• OECD 442E Human Cell Line Activation Test (h-CLAT) Acute toxicity
• OECD 439/431 Skin irritation/corrosion: Reconstructed Human
• OECD 492 Eye irritation: Reconstructed human Cornea-like
• Epiocular™ epithelium (RhCE) test method
• OECD 402 Dermal toxicity chemicals
• OECD 404 Dermal irritation chemicals
• OECD 405 Eye irritation chemicals
• OECD 406 Buehler skin sensitization chemicals
• OECD 423 Oral toxicity.

Additionally, Bioassay Labs can test for proliferation & signal transduction, cytotoxicity and can conduct live cell analysis using flow cytometry or fluorescence activated cell sorting (FACS) procedures.

Bioassay’s analytics laboratories at the Heidelberg Technology Park in southern Germany have more than 1,000 m² of floorspace, accommodating state of the art in-vivo and in-vitro facilities and leading-edge equipment. The labs are subject to regular inspections by regulatory authorities and customer audits, as well as Bioassay’s own internal QA audits. The laboratories’’ standards and qualifications are further confirmed underlined by Bioassay’s participation as a trusted partners various international collaboration studies.

Resources

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