Residual DNA Testing
Eurofins GeneScan has over 10 years of experience in residual host cell DNA testing offering services from assay development to routine testing in a GMP compliant environment, if required. As a world-leading laboratory for Genetically Modified Organism (GMO) testing for the food and agricultural industries, Eurofins GeneScan has profound knowledge of trace amount DNA extraction from a wide variety of matrices and has set standards in the development of PCR assays and routine testing in the GMO field.
Residual host cell DNA can be present in all products of the food, feed, chemical and biopharmaceutical industry purified from various host cell systems. Residual host cell DNA testing of these products is relevant in the context of scientific risk assessment and approval. Eurofins GeneScan is your partner of choice for the detection and quantification of residual host cell DNA in your product for quality assurance or DNA clearance studies in the production process.
Your Contact for all Inquiries Concerning Residual DNA Testing
Philipp Hauri
Analytical Service Manager Residual DNA Testing
Eurofins GeneScan GmbH
Tel.: +49 (0) 761 5038 131
E-Mail: DNA@eurofins.de
Petra Richl
Laboratory Manager Residual DNA Testing / GMP
Eurofins GeneScan GmbH
Tel.: +49 (0) 761 5038 100
E-Mail: DNA@eurofins.de
Our Parameters for Residual DNA Testing
Our purpose is to assure our clients the safety and success of their products by providing services of outstanding technical quality and regulatory rigor. We offer our customers a range of routine services for testing of residual host cell DNA, also in a GMP compliant environment. Additionally we develop innovative and reliable solutions to meet the specific analytical demands of our customers and the authorities.
- Extraction of trace amounts of DNA by specific sample preparation methods
- Quantification of total DNA content by PicoGreen™
- Residual DNA testing for the food, feed and chemical industry
- Corynebacterium glutamicum- Bacillus subtilis- E. coli- Antibiotic resistance genes- Additional host organisms or targets on request
- Residual DNA testing for the biopharmaceutical industry
- CHO- E. coli- Pichia pastoris (available soon)
- Method Development of residual DNA assays
Do you need any further information about residual DNA testing? Please contact us.
Guidelines and Regulations Important for Residual DNA Testing
Food and feed
Residual host cell DNA impurities in food and feed can occur in processing aids and additives produced by genetically modified microorganisms (GMMs). In the EU, an authorisation procedure for food enzymes, additives and flavours comes into force on September 11 2011 (Regulation (EC) No 1331/2008 and 234/2011). The producer has to hand in an application to the EFSA in the following 24 months. This includes GMM produced substances, such as vitamins, amino acids and enzymes.
In the USA, every substance to be sold in food has to obtain a ‘Generally recognized as safe’ (GRAS) notice from the FDA before market release.
For the approval by the EFSA or the FDA, a risk assessment is mandatory. For substances derived from GMMs it includes testing for the presence of producer strain organisms and residual recombinant DNA. If residual recombinant DNA is present in the final product, the likelihood of gene transfer and the potential risk of the recombinant DNA have to be assessed.
Biopharmaceuticals
A growing number of pharmaceutical substances are produced in biological host cell systems (bacteria, yeast and eucaryotic cell lines). These so called biopharmaceuticals are potentially contaminated by residual host cell DNA.
The WHO and regulatory authorities in the US (FDA) and EU (EMA) have recognized the potential dangers of residual host cell DNA in biopharmaceutical products. The acceptable amount of residual host cell DNA impurities depends on the source and route of administration. Specified by WHO guidelines is 10 ng residual host cell DNA per parenterally administered dose. While the EMA follows these considerations, the FDA requires levels down to 100 pg residual host cell DNA or less per parenterally administered dose, if the products are derived from continuous cells with tumorigenic or other characteristics giving rise to special concerns.
Relevant Products
... and many others - just don't hesitate to ask!
Cutting-edge Laboratory Equipment for Residual DNA Testing
Our facilities are equipped with separated DNA extraction and pre- and post-PCR areas, following a strict one-way workflow and dedicated equipment for each level to guarantee the most reliable results to our customers.
Sample extraction and purification
- Equipment for low to high throughput sample preparation and DNA extraction, including
- Liquid Handling Workstations- Automated DNA extraction and purification system
Analytical devices
- More than 10 real-time PCR devices and a number of standard thermocyclers including:
- ABI 7500 Standard and Fast with 21 CFR Part 11 Software- ABI Prism 7900HT- Agilent Mx3000P/Mx3005P
Our Most Important Methods for Residual DNA Testing
- Qualitative (real-time) PCR
Qualitative testing for the presence of residual host organism and recombinant DNA. - Quantitative real-time PCR (qPCR)
Quantitative real-time PCR allows the quantification of specific residual host cell DNA sequences in the sample. It is a fast and sensitive method with a limit of quantification (LOQ) in the sub-picogram range. - Quantification of total DNA content by PicoGreen™
The PicoGreen™ assay allows the quantification of the total DNA content by detection of a fluorescent dye unspecifically binding to double-strand DNA in the sample.