R-Pharm to produce biological drugs using GE Healthcare's FlexFactory

The share of pharmaceuticals made locally in Russia has risen from 4% in 2009 to 35% in 2015

From the left: Maksimkina Elena, Director of the Department for Pharmacological Support and Regulation of the Circulation of Medical Supplies, Ministry of Healthcare, Russia; Vladislav Shestakov, Head of State Institute of Pharmaceuticals and Satisfactory Practices, Ministry of Industry and Trade of Russia; Vasily Ignatiev, CEO, R-Pharm, Russia and Avdeev Maxim, Deputy Chairman of the Government, Yaroslavl region

R-Pharm Group has opened a biopharmaceutical production plant equipped with GE Healthcare’s FlexFactory manufacturing platform in Yaroslavl, Russia.

The plant will produce biologics and biosimilars for treating autoimmune diseases and cancer and increase access to these therapies for patients in the region.

It will have a line capacity of 2,000 L of cell culture for each production cycle.

Representatives from R-Pharm, including Vasily Ignatiev, CEO, R-Pharm Russia and Andrei Demurin, Head of GE Healthcare’s Life Sciences division in Russia, were joined by representatives of Russian Ministries of Public Health and Industry and Trade, Federal Service for Surveillance in Healthcare, as well as by the regional government in Yaroslavl to officially open the facility.

Opening of a new biopharma production platform, such as R-Pharm’s FlexFactory, shows that we have the right targets and milestones in place

Sergey Tsyb, Deputy Minister of Industry and Trade of the Russian Federation, said modern technologies have an important role to play for Russian biopharmaceutical companies developing new products within the national Pharma-2020 programme.

'Opening of a new biopharma production platform, such as R-Pharm’s FlexFactory, shows that we have the right targets and milestones in place, and that companies are helping us to reach the objectives that we have set in the programme,' he said.

According to Olga Kolotilova, Head of Department of Development of Pharmaceutical and Medical Industry for Ministry for Industry and Trade, Russian Federation, since the implementation of the programme, a number of foreign biopharmaceutical companies are now manufacturing in Russia, and as a result, the share of pharmaceuticals made locally has risen from 4% in 2009 to 35% in 2015.

'I’m certain that opening of the new production platform by R-Pharm will be a further catalyst for continued growth,' she said.

R-Pharm said GE Healthcare’s FlexFactory will allow the firm to reduce biologic time-to-market and increase production flexibility, while remaining in compliance with global regulations and quality standards.

GE FlexFactory installed within R-Pharm’s newly opened biopharmaceutical production plant

The FlexFactory is now ready to be validated according to US and Russia FDA and GMP requirements.

Ignatiev said: 'We are pleased to announce the opening of our FlexFactory that will be used to produce biopharmaceuticals for treatment of autoimmune and oncological diseases.

'There is an increasing need for new treatment methods which is highlighting the necessity to develop new biopharmaceuticals and improve diagnostics and treatment.'

Demurin added: 'The opening of a manufacturing line in Yaroslavl equipped with GE Healthcare’s FlexFactory technology is a significant step for Russian healthcare.'

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