Identification and optimization of critical process parameters for the production of NOMV vaccine against Neisseria meningitidis

Highlights ► We optimized detergent-free OMV extraction for vaccine production. ► Two critical process parameters were identified (harvest point and extraction pH). ► They changed OMV yield (8-fold) and bacterial lysis (35-fold). ► Setpoints were optimized and functional properties of the vaccine we...

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Bibliographic Details
Published in:Vaccine 2012-05, Vol.30 (24), p.3683-3690
Main Authors: van de Waterbeemd, Bas, Streefland, Mathieu, van Keulen, Lonneke, van den IJssel, Jan, de Haan, Alex, Eppink, Michel H, van der Pol, Leo A
Format: Article
Language:English
Subjects:
Allergy and Immunology
b meningococcal vaccine
Biotechnology - methods
Chelating agents
Chemical Fractionation
Detergents
disease
Edetic acid
Edetic Acid - chemistry
EDTA (chelating agent)
EDTA extraction
escherichia-coli
Exosomes - immunology
Harvest
Humans
immune response
Immunogenicity
Lipopolysaccharides
Membrane vesicles
Meningococcal Infections - prevention & control
Meningococcal Vaccines - immunology
Meningococcal Vaccines - isolation & purification
Neisseria meningitidis
Neisseria meningitidis, Serogroup B - immunology
OMV production
Optimization
Outer membranes
outer-membrane vesicles
pH effects
protein
QbD (Quality by Design)
release
serogroup-b
serotypes
serum bactericidal activity
strains
Technology, Pharmaceutical - methods
Toxicity
Vaccines
Vesicles
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Summary:Highlights ► We optimized detergent-free OMV extraction for vaccine production. ► Two critical process parameters were identified (harvest point and extraction pH). ► They changed OMV yield (8-fold) and bacterial lysis (35-fold). ► Setpoints were optimized and functional properties of the vaccine were confirmed. ► The OMV extraction is robust if harvest and pH are controlled accurately.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2012.03.028