Moscow, Russia
Moscow, Russia

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PubMed | PHARMAPARK LLC and Lomonosov Moscow University of Fine Chemical Technology
Type: Journal Article | Journal: SpringerPlus | Year: 2016

Recombinant monoclonal antibodies (mAbs) against tumor necrosis factor alpha are widely used in the biopharmaceutical therapy of autoimmune diseases. Currently, a large number of drugs based on these antibodies are available. Accordingly, the development of these products for the Russian market is an important goal. The aim of the current study is to describe the development of one such technology. CHO-DG44-derived cell lines producing mAb were developed using two strategies, one based on individual clones and the other based on cell pools. To obtain recombinant cell lines with highly amplified genes of interest, the clones underwent dihydrofolate reductase-mediated gene amplification. Using the best strategy for the selection and amplification of mAb-producing clones, we achieved the production of more than 1g/L in small scale, non-optimized conditions.

Shamonov N.A.,LLC Pharmapark | Zyrianov D.A.,LLC Pharmapark | Selishchev S.V.,LLC Pharmapark | Orlova N.V.,LLC Pharmapark | And 2 more authors.
Russian Journal of Biopharmaceuticals | Year: 2015

In this article we demonstrated a new method for producing monopegylated interferon alpha-2b without N-terminal isoform, possessing a low antiviral activity. The idea of the proposed method: the pegylation process we subjected the precursor of interferon alpha-2b, which is a fusion protein consisting of one molecule SUMOl yeast protein and one molecule of interferon alpha-2b. The pegylated precursor was further proteolysis with specific to the protein SUMOl ULP proteinase. After proteolysis and further purification we received monopegylated interferon al-pha-2b without N-terminal isoform. © 2015, Folium Ltd. All rights reserved.

Shamonov N.A.,LLC Pharmapark | Zyrianov D.A.,LLC Pharmapark | Selishchev S.V.,LLC Pharmapark | Orlova1 N.V.,LLC Pharmapark | Khamitov R.A.,LLC Pharmapark
Russian Journal of Biopharmaceuticals | Year: 2014

In this article we investigated pegylation process of recombinant interferon alfa-2a at the stage of the conjugation reaction. We offered mechanism for increasing the yield of the reaction by using an organic solvent (DMSO) as a component of the reaction buffer. It has been demonstrated that the addition of DMSO to a concentration of 30 % can increase the reaction yield by 40 % without changing the composition of the isoform formulation. To analyze the results of pegylation reaction we used the following analytical techniques: high performance liquid chromatography (ion exchange and gel permeation). © 2014 Folium Ltd. All rights reserved.

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