Research and Development

The Department’s activities are focused on the method of producing proteins used for the treatment of socially significant diseases: oncological, autoimmune diseases, etc.

About the Division

The idea of creating affordable, high quality drugs united people with biological, pharmaceutical, medical, biotechnological, and engineering education, having work experience in state research institutes and private pharmaceutical companies in Russia and abroad. The R&D Department of Mabscale, LLC includes two research groups working in Togliatti and Moscow.

The Company’s R&D team has brought together people who were among the first in Russia to obtain strains producing recombinant proteins based on CHO suspension lines more than 10 years ago.

About the Company
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Drug is at clinical trials stage
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Drug is at preclinical trials stage
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Drugs under development

Main R&D areas

Creating proprietary expression vectors and cell platforms for obtaining producer lines

The molecular biology group of the R&D Department creates proprietary expression systems to obtain highly productive clones.

Development of methods for producing recombinant proteins in mammalian cells

The R&D Department’s team has accumulated a lot of information about nutrient media and supplements available in the market, the modes of their use, their impact on the quality parameters of the target protein, and has an extensive experience in using the same. Based on the data obtained, they have developed rational approaches to the choice of cell cultivation conditions and reduced the time for the method optimization.

The division knows how to significantly increase the target protein yield and to adjust the glycosylation profile and isoforms; they have mastered and successfully used modern effective approaches to protein purification from related and unrelated impurities with minimal losses.

Scaling and transfer of developed methods into production

Transferring a laboratory method into production is one of the most critical moments in the life cycle of drugs requiring not only highly qualified staff, but also special equipment. In close cooperation with production divisions, the R&D Department carries out the method transfer and participates in the development of pilot series. 

Development of analytical techniques and regulatory documents

The R&D Department tasks include: development of quality control methods for manufactured medicines, their validation and transfer to the control and analytical laboratory, preparation of regulatory documents. The department has a wide range of methods at its disposal: HPLC, capillary electrophoresis, IFA and cell tests, which allows for strict control of manufactured products in accordance with modern pharmacopoeia requirements.

Bioanalytics

As part of preclinical and clinical trials of biotechnological drugs, the R&D Department performs the following functions:

Measurement of active ingredient concentration in blood serum samples, calculation of pharmacokinetic parameters.

Detection of antibodies to drugs, evaluation of their neutralizing ability in functional cellular test systems.

Assessment of the allergenic ability of drugs.

Development and validation of methods for measuring concentration of the active ingredient in blood serum and detection of antibodies to drugs.

Pipeline