MasterPlasma is building a 5bn RUB ($76m) facility in Vladimir, Russia for the manufacture of drug products extracted from human plasma and has signed a $1m agreement with Swedish pharma engineering firm KeyPlants for the design of the plant.
The facility is set to be operational by the end of 2017 and will process up to 600,000 litres of plasma annually.
Masterplasma licensed protein extraction and purification technology from Canada-based ProMetic Life Sciences, but as the process technology for production of some of the coagulating factors is still under development, KeyPlants has to build in a certain flexibility in the design, Tanja Sjödin, Regional Manager of Russia, CIS & Baltics, told this publication.
“What makes the task even more complicated is the fact that MasterPlasma is in parallel constructing the building which will house the future facility, and this brings some limitations in the design efforts,” she said.
“According to ProMetic process the separation of flows - personnel, material, product, waste, ventilation - must be kept up not only between different products derived from plasma, but even between different production steps for each product,” she continued, adding: “What KeyPlants experts actually achieved already in the Conceptual Design study was the development of a principal new facility design – a know-how optimized for the Plasma Protein Purification technology.”
While ProMetic licensed the technology to MasterPlasma, the firm kept open the possibility to sell the products made at the Vladimir facility outside Russia, and thus the plant is being designed only for the use of FDA and EMA certified plasma products, such as Plasminogen – designed to provide replacement therapy for patients who suffer from a congenital lack of the normal plasminogen protein.
“Overall, this project is an perfect example of international business collaboration aimed to bring health to people in the whole world, and our company is very proud to be a part in it,” Sjödin said.
Russia Pharma 2020
MasterPlasma operates as part of the Generium science and Technology Park, and the Vladimir blood plasma facility developed is being developed within the framework of Pharma 2020, the state programme of import substitution aimed at driving Russia’s own drug industry.
“KeyPlants has been on the Russian market for several years performing design studies and GMP reviews for both state owned and private pharmaceutical and biotech companies,” Sjödin told us.
“But by this contract we have achieved a principal new level: this project is supposed to become the flagship of the pharmaceutical industry in Russia.”