Bioassay GLP Cosmetic Assay Services

Heidelberg-based independent contract analytics laboratory Bioassay GmbH specializes in pharmacological and toxicological bioanalytical lab services based on GLP Good Laboratory Practice guidelines to provide a platform for GMP certification and production.

These services include a comprehensive suite of assays that are relevant to cosmetic, cosmeceutical and chemical products.

Standardized GLP Certified Cosmetic and Chemical Safety Assays

Bioassay’s portfolio of standardized GLP-certified safety assay formats for chemical and cosmetic products includes the most important tests required in three crucial areas:

• Skin sensitization: A panel of assays including OECD 442B Local Lymph Node Assay (LLNA) chemicals, OECD 442C Direct Peptide Reactivity Assay (DPRA) and Amino Acid Derivative Reactivity Assay (ADRA), OECD 442D ARE-Nrf2 Luciferase Test Method (KeratinoSens™), and OECD 442E U937 Cell Line Activation Test (U-SENS™) and Human Cell Line Activation Test (h-CLAT).
• Acute toxicity: Toxicity assays including OECD 439/431 Skin irritation/corrosion: Reconstructed Human Epidermis Test Method (Epiderm™), OECD 492 Eye irritation: Reconstructed human Cornea-like Epithelium (RhCE) test method (Epiocular™), OECD 402 Dermal toxicity chemicals, OECD 404 Dermal irritation chemicals, OECD 405 Eye irritation chemicals, OECD 406 Buehler skin sensitization chemicals, and OECD 423 Oral toxicity.
• Custom made assays: Often standard assays do not entirely align with specific product properties and more specific tests are required. Bioassay can design customized assays tailored to individual Cosmeceutical products in the areas of bioactivity, Proliferation & Signal Transduction, cytotoxicity and FACS-based Assays.

GLP Lab Facilities

Bioassay’s GLP-certified analytics laboratory is located at the Heidelberg Technology Park in southern Germany. The laboratory has more than 1,000 m² of floorspace, accommodating state of the art in-vivo and in-vitro facilities and leading-edge equipment.

Regular upgrading of staff qualifications and testing systems are both for the validity of processes. For this reason, Bioassay places particular emphasis on in-house and external training of its employees.

Quality must be verifiable and therefore Bioassay bioanalytical laboratories undergo regular inspections by regulatory authorities and customer audits, in addition to the company’s own QA audits.

Resources

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