Application of Microbes in Vaccine Production

2022 ◽  
pp. 573-585
Author(s):  
Arka Bagchi ◽  
Partha Saha ◽  
Arunima Biswas ◽  
Sk Manirul Islam
Keyword(s):  
Vaccine Production

Determination of Specific Activity of Cholera Chemical Vaccine Components using Cell Culture

2020 ◽  
Vol 36 (3) ◽  
pp. 82-89
Author(s):  
O.V. Gromova ◽  
O.S. Durakova ◽  
S.V. Generalov ◽  
L.F. Livanova ◽  
O.A. Volokh
Keyword(s):  
Cell Culture ◽  
Vibrio Cholerae ◽  
Production Control ◽  
Specific Activity ◽  
Methodological Approach ◽  
Toxin Production ◽  
Submerged Cultivation ◽  
Vaccine Production ◽  
Antigenic Activity

Том 36(2020) №3 стр. 82-89; DOI 10.21519/0234-2758-2020-36-3-82-89А.В. Гаева1*, О.В. Громова1, О.С. Дуракова1, С.В. Генералов1, Л.Ф. Ливанова1, О.А. Волох1 Определение специфической активности компонентов холерной химической вакцины с использованием культуры клеток 1ФКУЗ «Российский научно-исследовательский противочумный институт «Микроб»» Федеральной службы по надзору в сфере защиты прав потребителей и благополучия человека, Саратов 410005 *[email protected] Поступила - 2019-11-26; После доработки - 2020-03-16; Принята к публикации - 2020-05-15 Список литературы Описаны методы определения динамики продукции токсинов штаммом Vibrio cholerae 569B при глубинном культивировании в биореакторе и антигенной активности специфической фракции холерогена-анатоксина по анатоксинсвязыванию с использованием клеточных культур. Показана высокая степень соответствия результатов, полученных методами, применяемыми для контроля этапов производства холерной химической вакцины и рассмотренными в данной работе. Отмечено, что применение клеточной линии СНО-К1 наиболее перспективно для замены биомоделей на промежуточных этапах контроля активных компонентов холерной химической вакцины. Разработанный методический подход впервые предлагается использовать на этапах производства холерной бивалентной химической вакцины. культура клеток, Vibrio cholerae, холерная химическая вакцина, контроль производства, холера. Vol 36(2020) N 3 p. 82-89; DOI 10.21519/0234-2758-2020-36-3-82-89A.V. Gaeva1*, O.V. Gromova1, O.S. Durakova1, S.V. Generalov1, L.F. Livanova1, O.A. Volokh1 Determination of Specific Activity of Cholera Chemical Vaccine Components using Cell Culture 1Russian Research Anti-Plague Institute «Microbe» of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, Saratov, 410005 *[email protected] Received - 26.11.2019; Accepted - 15.05.2020 References The methods has been described to determine the dynamics of toxin production by the Vibrio cholerae 569B strain during submerged cultivation in bioreactor and of the antigenic activity of specific choleragen anatoxin fraction by anatoxin binding levels using cell cultures. High degree of consistency was observed between the results obtained via the method under consideration and those obtained via control methods at different stages of cholera chemical vaccine production. It was shown that the CHO-K1 cell line is the most promising substitute for biomodels at the intermediate stages of control of active cholera chemical vaccine components. The developed methodological approach was first proposed for use at the stages of cholera chemical bivalent vaccine manufacturing. cell culture, Vibrio cholerae, cholera chemical vaccine, production control, cholera.

scholarly journals Scaling-up vaccine production: implementation aspects of a biomass growth observer and controller

2008 ◽  
Vol 32 (3) ◽  
pp. 289-299 ◽  
Author(s):  
Zita I. T. A. Soons ◽  
Jan van den IJssel ◽  
Leo A. van der Pol ◽  
Gerrit van Straten ◽  
Anton J. B. van Boxtel
Keyword(s):  
Scaling Up ◽  
Biomass Growth ◽  
Vaccine Production ◽  
Implementation Aspects

A Contamination Control Strategy Gone Wrong

2021 ◽  
Vol 25 (5) ◽  
Author(s):  
Jeanne Moldenhauer
Keyword(s):  
Control Strategy ◽  
Control Strategies ◽  
Pharmaceutical Manufacturing ◽  
Production Facility ◽  
Vaccine Production ◽  
Contamination Control

Warning letters and regulatory inspection observation reports (e.g., FDA 483) often provide useful information for assessing risks in your facility and preparing for upcoming inspections. Starting with the updates to the European Union’s Annex 1 for the Manufacture of Sterile Drugs there has been an increased focus on contamination control strategies in facilities. A contamination control strategy is an integral part of pharmaceutical manufacturing, whether sterile or non-sterile. For this article we are going to look at a series of observations for a vaccine production facility and how we might learn from these observations. Highlighted are some of the contamination control issues. The FDA 483 Report was published in redacted form.

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