Certification of a pharmacopoeial reference standard for potency testing of recombinant interferon α-2b
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, the quality of interferons should be assessed usi...
Main Authors: | L. A. Gaiderova, Yu. N. Lebedeva, T. N. Lobanova, E. K. Lipatova, R. A. Volkova, O. V. Fadeikina |
---|---|
Format: | Article |
Language: | Russian |
Published: |
Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2024-03-01
|
Series: | Биопрепараты: Профилактика, диагностика, лечение |
Subjects: | |
Online Access: | https://www.biopreparations.ru/jour/article/view/550 |
Similar Items
-
Development and certification of a pharmacopoeial reference standard for primary structure identification of purified recombinant interferon beta-1b by peptide mapping
by: E. O. Goloshchapova, et al.
Published: (2022-04-01) -
Human anti-D immunoglobulin preparations: potency standardisation milestones
by: N. S. Vildanova, et al.
Published: (2022-10-01) -
Development, certification, and use of a pharmacopoeial standard for the content of immunoglobulin A in human immunoglobulins for parenteral administration
by: A. V. Nechaev, et al.
Published: (2023-10-01) -
Requirements for the information on reference standards submitted in the dossier for biologicals
by: R. A. Volkova, et al.
Published: (2024-03-01) -
DEVELOPMENT AND CHARACTERIZATION OF POLYCLONAL ANTIBODY OF RECOMBINANT HUMAN INTERFERON Α2B IN NEW ZEALAND WHITE RABBIT
by: Heny Rachmawati, et al.
Published: (2014-07-01)