A ceremonial opening of a new line for production of medicinal proteins took place at R-Pharm finished dosage form production facility in Yaroslavl. The following persons participated in the ceremony: Alexey Repik, Chairman of Board of Director of R-Pharm group; Vasily Ignatiev, Director General of R-Pharm; Sergey Tsyb, Deputy Minister of Industry and Trade of the Russian Federation; Olga Kolotilova, Director of Pharm and Medical Industry Development Department of Ministry of Industry and Trade; Elena Maksimkina, Director of Drug Provision and Medical Products Control Department of Ministry of Health; Vladislav Shestakov, Director General of the State Institute of Drugs and Good Practices, and Andrey Demurin, Director of GE Healthcare Life Sciences Division in Russia/CIS. The event took place within the All-Russian GMP Conference I in Yaroslavl.
Commitment to reducing operating and treatment costs calls for enhancement of drug manufacturing methods. Biopharmaceutical companies around the world are looking for new ways to increase manufacturing flexibility at the same time keeping to international quality standards. To that end, R-Pharm made a decision to equip the medicinal protein manufacturing line in Yaroslavl with FlexFactory integrated platform designed by GE Healthcare Life Sciences division. R-Pharm total investments into the project make over 1,5 bln roubles.
The platform based on application of innovative, so-called, single-use technologies allows producing considerable amounts of MAbs (monoclonal bodies) and other biotechnological products. As opposed to the standard solutions, single-use technologies help to considerably save costs and time. At every stage of production (cultivation, purification, chromatography) single-use components are applied. They are utilized immediately after their use and are replaced by new ones and this helps to avoid labor consuming and expensive purification process. Application of single-use technologies provides flexibility in modification of production processes and a prompt rebuild of a line for production of new products if required. A unified automation system allows to control the whole workflow and adjust single processes. That helps to simplify equipment installation and assembly and its implementation on site. Besides, single-use technologies allow to exclude contamination of produced products and to reduce costs for purification of the processing line after production of a new batch of products.
FlexFactory makes it possible to promptly place the equipment into operation: in average it takes about 12 months to go through all the stages from project engineering to full certification and start-up of the line. This is much less than required for building a conventional line. As for Yaroslavl plant the assembly of the innovative equipment was initiated in spring 2015 and by October the equipment was already approved for operation. This made it possible to proceed with experimental production and to get the first industrial batch of products for preclinical studies in early 2016.
Launch of a new line of biopharmaceuticals is an important step to batch production of biopharmaceuticals including innovative products and biosimilars with high export potential. The production line is validated according to GMP requirements.
According to Sergey Tsyb, Deputy Minister of Industry and Trade of the Russian Federation, “domestic companies make extensive use of support tools within the national Pharma-2020 program. R-Pharm, one of the largest investors in the region, is the participant of this program. Opening of production platforms like FlexFactory indicates that we have chosen the right objectives and targets and that is why companies help us to reach the goals that we have set in Pharma-2020 program”.
“Promising outlook for the protein production technology introduced in Yaroslavl is due to the possibility to use biological products for the treatment of a variety of diseases. Moreover, it is due to such kind of drugs that modern medicine has managed to find solutions to many medical problems that could not be solved in the recent past. Among the challenges are those related to the treatment of oncological, cardiovascular, immunological and other socially significant diseases”, stated Alexey Repik, Chairman of Board of Directors of R-Pharm group, during the opening ceremony.
“We are glad to announce the opening of an innovative line for manufacturing of high-potent drugs developed for the treatment of autoimmune and oncological diseases. There is an increasing demand for advanced treatment modes and that proves the need to develop and enhance diagnostics and treatment”, noted Vasily Ignatiev, Director General of R-Pharm group.
Andrey Demurin, Director of GE Healthcare Life Sciences in Russia/CIS, said: “We are proud of the opportunity to offer innovative solutions to the key issues that the Russian pharm industry faces within the state Pharma-2020 program. The opening of a new production line in Yaroslavl based on GE Healthcare FlexFactory technology is an important event for the domestic healthcare. Capacity of the line is 2000 liters per year. This means that the Russian patients will be provided by high quality medicinal drugs available in sufficiency”.
FlexFactory is a fully integratable optimized biotechnological platform that allows manufacturers to quickly and easily set up an automated biopharmaceutical production. The line provides for a fast start-up of production of the main biological products such as antibodies and vaccines starting with cell culture cultivation and finishing with production of a bulk dosage form. FlexFactory equipment is based on single-use technologies, and that helps to considerably save time, decrease capital and industrial expenses as compared to the standard equipment made of stainless steel. The line includes processing equipment and all required components for automation and control of a full cycle production of biopharmaceuticals. Platform scaling feature helps to considerably reduce time required to change or develop a new production line. The platform can be redesigned according to a customer’s request in order to meet the targets of a new or existing industrial facility. The experts of GE Healthcare Life Sciences give personnel trainings and provide consulting and service backup at all stages of equipment buildup and operation.