Bioassay GmbH

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Bioassay GmbH?

Overview

Bioassay GmbH is an independent contract laboratory, specializing in the development, validation and routine performance of bioanalytical assays in the area of Pharmacology and Toxicology.We carry out qualified analytical services on the sound basis of our FDA GMP & GLP certification, which provides an excellent framework for successful projects and routine bioanalysis. Key global players as well as start-up companies in the pharmaceutical and chemical industries trust in the experience and dedication of our bioanalytical experts.

Standards & Methodologies

In-vivo and Cell based assays, Development, Validation & Routine analysis of potency assays, FACS based multiplex analyses, Validation of bioassays based on ICH guidelines

Qualifications, Certifications, Accreditations & Licenses

GMP: Erythropoietin Potency Determination (Pharm. Eur. 1316), GCSF Potency Determination (Pharm. Eur. 2216), GH Potency determination (Validated to ICH Guidelines), Endotoxin Testing (Pharm. Eur. 2.6.14) GLP: Category 2 (Toxicology)

Industries Served

  • Biologics
  • Pharmaceutical

Testing Types

  • Flow Cytometry
  • Immunoassays
  • In-Vitro
  • Quality Control
  • Sensitization

Publications

Bioassay GmbH has not posted any publications.

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