International Approaches to Regulation of Medicinal Products Containing Viable Human Cells
Melnikova, E. V., Goryaev, A. A., Savkina, M. V., Merkulova, O. V., Chaplenko, A. A., Rachinskaya, O. A., Semenova, I. S., Trusov, G. A., Merkulov, V. A.
Published in Biopreparaty (28.09.2018)
Published in Biopreparaty (28.09.2018)
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Genome-Editing and Biomedical Cell Products: Current State, Safety and Efficacy
Goryaev, A. A., Savkina, M. V., Mefed, K. M., Bondarev, V. P., Merkulov, V. A., Tarasov, V. V.
Published in Biopreparaty (28.09.2018)
Published in Biopreparaty (28.09.2018)
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Microbial Quality of Dehydrated Media Used in the Sterility Testing of Immunobiological Medicinal Products
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Methodological Approaches to Validation of Therapeutic Recombinant Proteins Production Based on the Quality by Design Concept
Stratonova, N. V., Lisov, A. S., Morozov, A. N., Tyupa, D. V., Khamitov, R. A.
Published in Biopreparaty (28.09.2018)
Published in Biopreparaty (28.09.2018)
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Approaches to Pharmaceutical Analysis of Modern Peptide and Oligonucleotide Products as Illustrated by a Small Interfering RNA-Based Novel Therapeutic for the Treatment of Bronchial Asthma
Krasnykh, L. M., Smirnov, V. V., Ramenskaya, G. V., Vasilenko, G. F., Shilovsky, I. P., Haitov, M. R.
Published in Biopreparaty (28.09.2018)
Published in Biopreparaty (28.09.2018)
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Recommendations for Expounding Evaluation of Biological (Specific) Activity of Biotechnological Products in Product Specification Files
Golovinskaya, O. V., Lysikova, S. L., Lebedeva, Yu. N., Alpatova, N. A., Movsesyants, A. A., Merkulov, V. A.
Published in Biopreparaty (28.09.2018)
Published in Biopreparaty (28.09.2018)
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Porcine Trypsin in the Manufacture of Biological Medicinal Products. Risks and Safety Requirements
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Trypsin. Properties and Use in the Production of Biological Medicinal Products
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Characterization of the Candidate Reference Material of Timothy Pollen Allergen Extract in Terms of Protein Profile and Specific Allergenic Components
Tcymbarevich, I. V., Efimova, I. S., Kalinin, S. P., Zubkov, A. V., Mazurina, S. A., Mikhailova, N. A., Zubkova, N. V.
Published in Biopreparaty (22.06.2018)
Published in Biopreparaty (22.06.2018)
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BCG Tuberculosis Vaccine: Immunological and Clinical Efficacy in Children Born to HIV-Infected Women
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Analysis of Batch to Batch Consistency of a Locally Produced Influenza Vaccine for the 2017–2018 Influenza Season
Demidova, P. V., Mefed, K. M., Davydov, D. S., Sarkisyan, K. A., Movsesyants, A. A., Merkulov, V. A.
Published in Biopreparaty (22.06.2018)
Published in Biopreparaty (22.06.2018)
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Molecular-Biological Methods of Quality Control of Biological Active Substances Produced by Recombinant DNA Technology
Mytsa, E. D., Chertova, N. V., Elbert, E. V., Sukhno, A. S., Volkova, R. A., Merkulov, V. A.
Published in Biopreparaty (22.06.2018)
Published in Biopreparaty (22.06.2018)
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Carbohydrate-Based Adjuvants for Vaccine Production
Kurashova, S. S., Dzagurova, T. K., Ishmukhametov, A. A., Egorova, M. S., Balovneva, M. V., Sotskova, S. E., Tkachenko, E. A.
Published in Biopreparaty (22.06.2018)
Published in Biopreparaty (22.06.2018)
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Development and Validation of a Procedure for Subvisible Particles Determination in Water for Injections by the Coulter Principle (Electrical Sensing Zone Method)
Voropaev, A. A., Fadeikina, O. V., Ermolaeva, T. N., Davydov, D. S., Volkova, R. A., Shvedov, D. V.
Published in Biopreparaty (22.06.2018)
Published in Biopreparaty (22.06.2018)
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Analysis of Efficacy and Safety of Tick-Borne Encephalitis Vaccines
Kozlova, T. Yu, Khantimirova, L. M., Rukavishnikov, A. V., Shevtsov, V. A.
Published in Biopreparaty (26.03.2018)
Published in Biopreparaty (26.03.2018)
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Use of Flow Cytometry for Quality Evaluation of Biomedical Cell Products
Trusov, G. A., Chaplenko, A. A., Semenova, I. S., Melnikova, E. V., Olefir, Yu. V.
Published in Biopreparaty (26.03.2018)
Published in Biopreparaty (26.03.2018)
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Evaluation of Immunobiological Properties of Bordetella pertussis Vaccine Strains
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Sterility Testing of Immonobiological Medicinal Products in Russia. Historical Background and Current Requirements
Sukhanova, S. M., Berdnikova, Z. E., Zakharov, N. E., Merkulov, V. A.
Published in Biopreparaty (26.03.2018)
Published in Biopreparaty (26.03.2018)
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