Antibodies

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Quality Policy

BioGenes is certified according to ISO 9001 since 1999.

More than that, the work performed in our labs, especially for industrial customers follows certain GMP standards.

Our quality system employs the following principles:

  • Animals and materials from certified suppliers
  • Quality according to US standards
  • Batch control system
  • Cell line history and cell banking
  • Assay validation according to the ICH guidelines
  • Validated analytical procedures
  • Documentation according to the regulatory guidelines
  • Well-experienced and regularly trained personnel
  • Internal audits routinely and audits by customers

Animal keeping and corresponding works are performed according to the following animal welfare regulations:


  1. German guidelines according to Animal Welfare Act of 12. August 2013 (BGBI.I, No. 36)
  2. European Union guidelines 2010/63/EC of 22.09.2010 and according to the European Agreement of 18.03.1986 for protection of animal trials and other for scientific purposes used vertebrates of 15.11.2007 (BGBI. II No. 37)
  3. NIH/OLAW Animal Welfare Assurance #A5755-01