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Scale-up for bulk production of vaccine against meningococcal disease.

Abstract：

:At the Netherlands Vaccine Institute (NVI) a vaccine against Neisseria meningitidis serogroup B organisms based on different porA subtypes contained in outer membrane vesicles (OMVs) is in advanced stage of development and will be evaluated in clinical trial studies in the near future. In order to meet the expected demand for product, the current biopharmaceutical production process is being scaled-up. This study describes the scale-up approach for the upstream process and the resulting bioreactor design and operation strategy leading towards a feasible solution for bulk production of a vaccine against meningococcal disease. The technically realized 1.2 m(3) bioreactor, equipped with a turbine impeller for gas dispersion, was complemented with an upward pumping impeller and a rotary plate foam breaker to contain foam inside the bioreactor. Aeration and ventilation in the culture broth were controlled by increasing the stirrer speed and gas flow rate simultaneously at increasing oxygen demand. The scale-up was successful and comparable growth curves and nutrient consumption profiles were reached on 0.06 and 1.2 m(3).

journal_name

Vaccine

journal_title

Vaccine

authors

Baart GJ,de Jong G,Philippi M,van't Riet K,van der Pol LA,Beuvery EC,Tramper J,Martens DE

doi

10.1016/j.vaccine.2007.06.008

subject

Has Abstract

pub_date

2007-08-21 00:00:00

pages

6399-408

issue

34

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(07)00680-9

journal_volume

25

pub_type

杂志文章

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