R-Pharm Opens a Production Plant with GE Healthcare's Flexfactory™ Manufacturing Platform

22 Sept 2016
Lois Manton-O'Byrne, PhD
Executive Editor

Industry news

R-Pharm Group has opened an innovative biopharmaceutical production plant equipped with GE Healthcare’s FlexFactory™ manufacturing platform in Yaroslavl, Russia. R-Pharm’s FlexFactory will support the mass production of biologics and biosimilars focused on treating autoimmune diseases and cancer, and allowing for increased access to these critical therapies for patients in the region.

Representatives from R-Pharm, including Vasily ignatyev, 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.

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 program. 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 program.”

“Since we started implementing the program, a large number of the major foreign biopharmaceutical companies made the decision to manufacture within Russia, and as a result, the share of pharmaceuticals made locally has gone 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,” said Olga Kolotilova, Head of Department of Development of Pharmaceutical and Medical Industry for Ministry for Industry and Trade, Russian Federation.

R-Pharm selected GE Healthcare’s FlexFactory to address a common biopharmaceutical industry challenge: the need to reduce biologic time-to-market and increase production flexibility, all while remaining in compliance with global regulations and quality standards. The FlexFactory platform enables manufacturers such as R-Pharm to rapidly respond to local healthcare needs by bringing more biological drugs to market at a quick pace. R-Pharm’s FlexFactory is now ready to be validated according to US and Russia FDA and GMP requirements.

Vasilii Ignatiev, CEO, R-Pharm Russia, 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.”

Andrei Demurin, Director of GE Healthcare Life Sciences in Russia, said: “We are proud of the opportunity to offer innovative solutions for the Russian biopharmaceutical industry that are enabling the industry to efficiently respond to the targets described in Pharma-2020. Opening of a manufacturing line in Yaroslavl equipped with GE Healthcare’s FlexFactory technology is a significant step for Russian healthcare. The line capacity is 2,000 L of cell culture per production cycle, and this should make a key contribution to the volume of biopharmaceuticals manufactured locally.”

Links

Tags

Scale-upScale-Up is generally defined as the process of transferring the results of the discovery phases of the drug discovery process, obtained on a laboratory scale, to the pilot plant and finally to production scale. Scale-Up uses reactors and pump systems as well as reagents, standards and buffers. Often Scale-Up is provided as a service by Contract Manufacturing Organizations (CMOs). Bioprocessing / FermentationBioprocessing is the use of biological materials to perform commercial, scientific or medical research processes. Biological materials used include cells, enzymes and organisms. Usually bioprocessing requires a batch or continuous bioreactor such as a fermentor or cell culture system. The advantages of using a reactor include high productivity, easy configuration, adjustable values and automation.BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.Vaccine DevelopmentVaccine development focuses on creating immunizations to protect against infectious diseases. The process involves identifying antigens, developing and testing vaccine efficacy, and ensuring safety through preclinical testing and multiple clinical trial phases. Scientists use various approaches, including weakened or inactivated viruses, protein subunits, or mRNA. Advanced platforms and rapid diagnostic tools aid in vaccine research and testing. Explore vaccine development solutions in our peer-reviewed product directory; compare products, read reviews, and get pricing directly from manufacturers.
R-Pharm Opens a Production Plant with GE Healthcare's Flexfactory™ Manufacturing Platform