The creation of a modern pharmaceutical infrastructure, including the construction of high-tech industrial complexes, is the most important direction of development for GEROPHARM.
Russian production: technology, competence, expertise
JSC GEROPHARM-Bio is a modern biotechnological production site, the first Russian industrial producer of recombinant human insulin, produced on a full-cycle basis from API to finished dosage forms. The company is included into group of companies GEROPHARM, it is located in the Serpukhov district of the Moscow region.
Today, the plant GEROPHARM-Bio is a flexible technology platform which allows to produce various recombinant proteins, to implement the full cycle of production of socially significant drugs. Through utilization of its own unique technology, the company produces short-acting insulin under the brand name Rinsulin® R (the solution) and intermediate acting Rinsulin® NPH (suspension)
You can tour a production complex GEROPHARM-Bio by watching our virtual tour:
The company gives preference to complicated science-intensive technology that requires professional knowledge and expertise. Today the plant produces sterile drugs: lyophilized forms and solutions or suspensions in vials, cartridges and syringe pens. The technology for the production of these drugs is patented by GEROPHARM and is a complex multistep process.
Compliance with international standards
A key strategic aspect for the country as a whole and for the company in particular is independence from foreign suppliers of raw materials: GEROPHARM produces both the substance (active ingredient) and the finished dosage forms. Three independent certified European laboratories – Proteome Factory AG, Berlin, Prolytic GmbH Frankfurt am Main, Labor L S AG, have tested and highly appreciated the quality of the substance of recombinant insulin and have confirmed its meeting requirements of British and American Pharmacopoeias.
To achieve high product quality GEROPHARM introduces advanced technology and the latest control methods. Most of the operations at the plant are performed by the automated production systems, which are absolutely unique for Russia. The company installed equipment from the companies-world leaders: Stilmas, Olsa, Groninger, Seidenader, Bausch+Ströbel, Uhlmann, Pester. Throughout the production cycle, there are more than 1000 points of quality control.
In 2014, the company successfully passed the inspection by the State service of Ukraine on medicinal products and received the Certificate of conformity of production to requirements of Good Manufacturing Practice (GMP).
In order to continuously maintain the GMP standards, the company has implemented an ongoing training program for the staff. The team consists of highly experienced experts who spearheaded the development of insulin and of young professionals, for whom the company has developed a system of mentoring, internships and training. Currently GEROPHARM is implementing a project to build another production facility in the pharmaceutical cluster of St. Petersburg.