Key quality control parameters for products being food, feed, pharmaceutics and cosmetics normally belong to small or very small amounts of contaminations. These are for example small amounts of DNA (around 100pg) that may be included in a biologically-derived drug substance.
Thus, an analytical method should be sensitive, robust, reliable and accurate. Quantitative Polymerase Chain Reaction (qPCR) is the analytical methodology with the lowest risk for performance failure for residual cellular DNA according to a new report (Andrade C. et al., 2018, A model of analysis in analytical methodology for biopharmaceutical quality control, PDA J. Pharm. Sci. Technol.) Using Hazard Analysis and Critical Control Points(HACCP) as an alternative approach to assessing the performance risks associated with quality control methods the authors were able to classify the steps in the analytical procedures according to their impact on method performance.
Imitating this for other contaminations that are able to threaten consumers, Tentamus laboratories are able to offer the best solutions for nearly every parameter and every matrix. Based upon the expertise of the different laboratories, the group is handing the projects to the lab with the best performance for the product. Analytical platforms are available that meet the highest technical standard. Analytics can be conducted using qPCR, ICP-OES, FTIR-Spektroskopie, LC-MS/MS, ELISA, Mesoscale, ELISpot and much more. And everytime a new project is starting, a risk analysis is conducted together with the client to identify the most suitable and most sensitive, robust, reliable and accurate methodology for their special need.
MicroMol is the expert lab for the aforementioned residual DNA, Bacteriophage contaminations, Biocompatibility and immunological projects based upon ELISpot or ELISA. Immunological projects with higher throughput are in good hands at VELA Labs in Vienna. Microbiological contaminations can be detected within 24 hours at BAV Institut in Offenburg. Genetically modified organisms are the core competence of Lifeprint in Illertissen. bilacon is looking after composition and value-determining ingredients of products, QSI in Bremen is competence center for food fraud.
Our 40 laboratories are your partners in routine and special projects discussing the methodology that is most purposeful with you, assisting in implementation, validation and routine measurements with sensitive, robust, reliable and accurate analytics.