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Biological Safety Testing

The biotechnology-derived products (biologicals) successfully make their way into the diagnosis, prevention and treatment of disease. However, there may be potential safety concerns that arise from their manufacturing processes and from the complex structural and biological characteristics of these products. Such products therefore require thorough biological safety testing which allows adequate assessment of safety before clinical investigation.

Vaccines and cell lines/cell banks used to produce these biologicals for example must be tested to ensure that they are free of adventitious agents (e.g. viruses or bacteria). A detailed characterization of the used cells and gene constructs is an essential part of the development process for biotechnology-derived products.

This requires:

  • testing for identity and integrity of the recombinant genes used to generate the product,
  • as well as testing for genetic stability of recombinant cell banks and production strains.

Eurofins Genomics is certified according to ISO 9001 and ISO 17025 and audited by pharmaceutical clients for GxP regulations.

Biotechnology - We serve all flavors

Whatever you call biotechnology, we deliver genomics services and tailored solutions to you!

The purpose of biotechnology is making use of living systems and organisms to develop or make useful products, or "any technological application that uses biological systems, living organisms or derivatives thereof, to make or modify products or processes for specific use" (UN Convention on Biological Diversity, Art. 2).

In particular, the following biotechnology fields can be defined according to a color code:

  • Red Biotechnology - drug development, diagnostics, biopharmaceuticals, antibodies, cell based systems, bioprocessing, genetic variation, (pre-)clinical studies. See also our Pharma & Diagnostics section.
  • White Biotechnology - enzyme, plant and microorganism based production of , pharmaceuticals, food ingredients such as vitamines or amino acids, bio-materials, biofuel and biomass, (fine) chemicals and enzymes for biodegradation
  • Green biotechnology - new plant and animal varieties for agriculture and bioproduction, biofertilizers and biopesticides, in vitro cultivation
  • Grey biotechnology - related to the environment, biodiversity measurement and maintenance, population genetics, microorganisms and plants for disposal and degradation of polluting substances
  • Blue biotechnology - use marine organisms (algae, fish etc.) and resources to create products and applications in food, health, treatment, cosmetics

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