Quality of RNA and viral vectors used in clinical trials is subject to strict regulation. Plasmids that are needed for production of these complex molecules are also on authorities’ radar. German-based biotech PlasmidFactory, delivers the right solution with its High Quality Grade plasmids.
For decades, artificially constructed plasmids have been used as vectors in genetic engineering to clone, amplify or express particular genes. A wide variety of plasmids are commercially available for such uses but not all of them are suitable for a clinical trial with humans.
The EMA (European Medicine Agency) has set up strict guidelines forcing clinical trials to use the highest quality standards. For example, Viral vectors or RNA need to be produced under GMP (Good Manufacturing Practices), a very strict guideline for laboratories. While plasmids don’t need a GMP authorization in these cases, they still need to be High Quality Grade. This quality standard requires highly purified DNA and a strong documentation on the production process.