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.
- 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 17025 and audited by pharmaceutical clients for GxP regulations.