Zobrazeno 1 - 10
of 163
pro vyhledávání: '"R A, Volkova"'
Autor:
L. A. Gaiderova, Yu. N. Lebedeva, T. N. Lobanova, E. K. Lipatova, R. A. Volkova, O. V. Fadeikina
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 24, Iss 1, Pp 21-31 (2024)
SCIENTIFIC RELEVANCE. Potency testing of recombinant interferons requires a reference standard. The availability of International Standards (ISs) that are commonly used to assess the quality of recombinant interferons is currently limited. Therefore,
Externí odkaz:
https://doaj.org/article/7f5cd8ab5a9b417ea6f74e8f58dd1222
Autor:
R. A. Volkova, O. V. Fadeikina, O. B. Ustinnikova, K. A. Sarkisyan, A. A. Movsesyants, V. A. Merkulov, V. V. Kosenko
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 24, Iss 1, Pp 7-20 (2024)
SCIENTIFIC RELEVANCE. The use of appropriately certified reference standards (RSs) is a necessary element of analytical procedure standardisation that ensures comparability of results across different laboratories assessing the quality of medicines,
Externí odkaz:
https://doaj.org/article/5144791c99b742c4bb2c374d35148a77
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 23, Iss 3-1, Pp 463-473 (2023)
Scientific relevance. The absence of blood-borne viruses in human plasma-derived medicinal products must be ensured by the control of raw materials and the manufacturing process.Aim. This study aimed to analyse system suitability criteria for analyti
Externí odkaz:
https://doaj.org/article/8e2e50628cb845c79fabc72b28ea5ec2
Autor:
A. V. Nechaev, E. Yu. Kudasheva, E. L. Postnova, R. A. Volkova, O. V. Fadeikina, I. V. Borisevich, A. A. Movsesyants
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 23, Iss 3-1, Pp 443-451 (2023)
Scientific relevance. The immunoglobulin A (IgA) impurity content in parenteral human immunoglobulins should be determined in accordance with the State Pharmacopoeia of the Russian Federation by kinetic nephelometry, radial immunodiffusion, or enzyme
Externí odkaz:
https://doaj.org/article/a2bc34d96ed248e7b7e62345dad71964
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 23, Iss 3-1, Pp 452-462 (2023)
Scientific relevance. GOST ISO/IEC 17025-2019 requires testing laboratories to evaluate the measurement uncertainty of their results. Estimating the uncertainty of analytical methods intended for biologicals is a challenging task that requires time,
Externí odkaz:
https://doaj.org/article/e81470a0a0374fca9ab6adaf54d157a7
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 22, Iss 2, Pp 218-225 (2022)
Reference standards for structure identification of recombinant therapeutic proteins are essential for quality assessment of recombinant protein-based biotechnological medicinal products. The development and certification of such reference standards
Externí odkaz:
https://doaj.org/article/63eaf08d48364d17b65b75efe5152f6a
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 22, Iss 1, Pp 49-59 (2022)
Assessment of prekallikrein content is essential for safety control of human immunoglobulin and albumin products. The inherent variability of human prekallikrein reagents and chromogenic substrates indicates the need for standardisation of the chromo
Externí odkaz:
https://doaj.org/article/37fe758fc7e4446e887bcdb59c0eb4c7
Autor:
E. O. Goloshchapova, O. B. Rounova, A. S. Minero, O. V. Fadeikina, R. A. Volkova, M. B. Degterev, S. A. Taran, R. R. Shukurov, O. B. Ustinnikova
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 22, Iss 1, Pp 23-37 (2022)
Medicines based on recombinant human interferons (rhIFNs) beta-1a and beta-1b are used as first-line treatment of multiple sclerosis. Meanwhile, rhIFN beta-1a and beta-1b have structural differences associated with the eukaryotic or prokaryotic expre
Externí odkaz:
https://doaj.org/article/e581ec390f4d49fa85d1caf3eb2d062f
Autor:
A. V. Muhacheva, O. A. Barkhaleva, O. V. Shapovalova, N. P. Neugodova, A. Yu. Butirskiy, A. A. Movsesyants, R. A. Volkova, K. A. Sarkisyan
Publikováno v:
Эпидемиология и вакцинопрофилактика, Vol 20, Iss 5, Pp 115-122 (2021)
Relevance. The presence of pyrogenic impurities in finished dosage forms of concentrated cultural anti-rabies vaccines produced in the Russian Federation is determined using pyrogenicity tests on rabbits (in vivo). In accordance with the decision of
Externí odkaz:
https://doaj.org/article/4a33e3440b514398a8fb20aef4b9ef4d
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 21, Iss 3, Pp 193-199 (2021)
Phenol is used as a preservative in a number of biological products. Methods that are used for quantitative determination of phenol differ a lot. Current requirements for accredited laboratories include continuous internal quality control. Reference
Externí odkaz:
https://doaj.org/article/50603ebf3b7a4e009ac141ae2df2a03d