Production – is the most important stage of the company's operations. For over 10 years we have been developing quality control systems, introducing innovative approaches and improving the efficiency of our work.
Currently, we operate a complete cycle of molecular and biological research solutions production. The company's manufacturing arm includes the following departments:
- new product development and validation
- high-performance oligosynthesis
- bulk manufacturing and reaction batch aliquoting
- finished reagent kit consolidation and packaging
- finished product quality control
The company's production facilities are located at the “SLAVA”, technological cluster, a specialized infrastructure project of the Department of Entrepreneurship and Innovative Development of the city of Moscow.
The company's manufacturing processes are in accordance with international GMP standards and the requirements of the ISO9001 international standard for quality control systems. The ISO9001 control system is subject to annual compliance audits by one of the largest European certifying bodies, TÜV SÜD Management Service GmbH. Manufacturing of reagent kits for forensic research is carried out in compliance with the IOS18385 international standard for the management of the risk of product contamination with human DNA.
At all stages of the manufacturing process, the principles of unidirectional flow of materials and products, incoming control of component and raw material contamination, management and mitigation of genetic material in the manufacturing environment are in place.
Preparation of all components and aliquoting of solutions are carried out in clean rooms of ISO7 class using automated processes and minimum direct participation of the operator in the manufacturing process. The clean room complex operation and particle level control is provided by a specialized air cleaning and conditioning complex using HEPA filtration systems.
Quality control of manufactured products is carried out by our own testing laboratory equipped with a full range of necessary analytical equipment. All products developed and manufactured at our facilities are part of the quality control systems of such international blind testing programs as GEDNAP (German DNA Profiling ) and ISAG comparison tests (International Society for Animal Genetics)