Current technology for the industrial manufacture of snake antivenoms

 

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Библиографические подробности
Авторы: León Montero, Guillermo, Vargas Arroyo, Mariángela, Segura Ruiz, Álvaro, Herrera Vega, María, Villalta Arrieta, Mauren, Sánchez Brenes, Andrés, Solano Blanco, Gabriela, Gómez Argüello, Aarón, Sánchez Chaves, Melvin, Estrada Umaña, Ricardo, Gutiérrez, José María
Формат: artículo original
Дата публикации:2018
Описание:Snake antivenoms are formulations of animal immunoglobulins used in the treatment of snakebite envenomation. The general scheme for producing snake antivenoms has undergone few changes since its development more than a century ago; however, technological innovations have been introduced in the manufacturing process. These medicines must comply with identity, purity, safety and efficacy profiles, as requested by the current Good Manufacturing Practices (GMPs) applied to modern biopharmaceutical drugs. Industrial production of snake antivenoms comprises several stages, such as: 1) production of reference venom pools, 2) production of hyperimmune plasma, 3) purification of the antivenom immunoglobulins, 4) formulation of the antivenom, 5) stabilization of the formulation, and 6) quality control of in-process and final products. In this work, a general review of the existing technology used for the industrial manufacture of snake antivenoms is presented.
Страна:Kérwá
Институт:Universidad de Costa Rica
Repositorio:Kérwá
Язык:Inglés
OAI Identifier:oai:kerwa.ucr.ac.cr:10669/103371
Online-ссылка:https://hdl.handle.net/10669/103371
https://doi.org/10.1016/j.toxicon.2018.06.084
Ключевое слово:snake antivenoms
envenomation
industrial biotechnology