SCALE-UP AND AUTOMATION
The large volume of reagents needed for the commercialization of molecular-diagnostic GENOMICA’s kits, requires a production process ensuring that large-scale manufacturing is performed according to those high quality standards previously demonstrated during small-scale kit development.
In full production, GENOMICA is able to manufacture individual batches of sufficient size to analyze up to 12,000 samples. This is achieved by means of a validation course that takes place between the stages of development and production of each kit, and which allows to ensure that changes due to significant increases in volumes as well as the use of robotic equipment for the automatic dispensing, do not affect those parameters critical for the kit performance, such as analytical and diagnostic reproducibility initially established during the development phase. This verification process guarantees that the products manufactured by GENOMICA on a large-scale maintain the highest quality standards for commercialization at national and international level.