On Serdix Capacities
First Batches of antiretroviral agent Tivikay (dolutegravir) manufactured by ViiV Healthcare have been issued by Pharmaceutical manufacturing site of Serdix in New Moscow.
It is of note, that a memo on launch of project was signed on May 25, 2016 within the framework of an annual forum, organized by Department of science, industrial policy and entrepreneurship under the Government of Moscow in the presence of Moscow mayor Sergey Sobyanin.
At the initial stage of implementation of the project of transfer of international technologies to the core production lines of Serdix a work on transformation and harmonization of analytical methods was performed, equipment was installed, and personnel training was performed. It is of note, that an agreement between Serdix and ViiV Healthcare involves transfer to Russia of full cycle production of Tivikay and partial technology transfer to the Russian counterpart.
At initial stage the site manufactured several batches of product without active substance (placebo). The first batch of the product with the active substance was aimed at parallel analysis of Serdix and ViiV Healthcare, in Russia and UK. Equivalence of the drug manufactured in Russia to internationally manufactured products at ViiV Healthcare has been confirmed.