Khlopin Radium Institute Finishes Major Upgrades to Medical Isotope Facility
On 7 December, the International Science and Technology Center’s (ISTC) project II-151, “Upgrade of diagnostic radiopharmaceuticals facility in compliance with GMP standards”, was successfully completed. As a result of the 700,000$ investment, the Khlopin Radium Institute, located in St-Petersburg, now complies with many of the Good Manufacturing Practices (GMP) international requirements regarding radiopharmaceutical production.
The upgrades in infrastructure, equipment, quality control, and personnel qualification will allow an increase in the quality of the medical isotopes and radiopharmaceuticals used in a whole range of clinics and hospitals in Russia. “In the last 20 years, over 1 million diagnostics have been carried out using the Radium Institute’s production of isotopes. And ISTC financial support guarantees we have the capacity to continue providing high quality radioisotopes for early detection of various diseases and health problems”, asserts Leonid Solin, II-151 Project Manager and Deputy Director of Research and Production of the Isotope Division.
Apart from isotopes for diagnostics, the Institute will now be able to extend its production to therapeutic radiopharmaceuticals to treat tumors and hyperthyroidism for example. These new capabilities will increase commercial potential of the Institute as well as diversify its sources of revenue.
ISTC has funded 3 consecutive projects on nuclear medicine worth 1,700,000$ and has been an important contributor to the Khlopin Radium Institute’s R&D program with a total 77 projects funded for a value surpassing $14 million. ISTC Executive Director, Adriaan van der Meer, stated: “We are very proud of these projects because they contribute to improving public health in Russia, while keeping the Khlopin Radium Institute facilities at a state-of-the-art technological level and thus more competitive on the market.”
Good Manufacturing Practice or "GMP" is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Russian government aims to impose GMP standards to all pharmaceutical companies by 1 January 2014.