Improved production process for native outer membrane vesicle vaccine against Neisseria meningitidis.

An improved detergent-free process has been developed to produce vaccine based on native outer membrane vesicles (NOMV) against Neisseria meningitidis serogroup B. Performance was evaluated with the NonaMen vaccine concept, which provides broad coverage based on nine distinct PorA antigens. Scalable...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Bas van de Waterbeemd, Gijsbert Zomer, Patricia Kaaijk, Nicole Ruiterkamp, René H Wijffels, Germie P J M van den Dobbelsteen, Leo A van der Pol
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2013
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/a7aca8616ff141fd93cc85f4a668c728
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:a7aca8616ff141fd93cc85f4a668c728
record_format	dspace
spelling	oai:doaj.org-article:a7aca8616ff141fd93cc85f4a668c7282021-11-18T07:43:25ZImproved production process for native outer membrane vesicle vaccine against Neisseria meningitidis.1932-620310.1371/journal.pone.0065157https://doaj.org/article/a7aca8616ff141fd93cc85f4a668c7282013-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/23741478/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203An improved detergent-free process has been developed to produce vaccine based on native outer membrane vesicles (NOMV) against Neisseria meningitidis serogroup B. Performance was evaluated with the NonaMen vaccine concept, which provides broad coverage based on nine distinct PorA antigens. Scalable aseptic equipment was implemented, replacing undesirable steps like ultracentrifugation, inactivation with phenol, and the use of preservatives. The resulting process is more consistent and gives a higher yield than published reference processes, enabling NOMV production at commercial scale. Product quality met preliminary specifications for 9 consecutive batches, and an ongoing study confirmed real-time stability up to 12 months after production. As the NOMV had low endotoxic activity and induced high bactericidal titres in mice, they are expected to be safe and effective in humans. The production process is not limited to NonaMen and may be applicable for other N. meningitidis serogroups and other gram-negative pathogens. The current results therefore facilitate the late-stage development and clinical evaluation of NOMV vaccines.Bas van de WaterbeemdGijsbert ZomerPatricia KaaijkNicole RuiterkampRené H WijffelsGermie P J M van den DobbelsteenLeo A van der PolPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 8, Iss 5, p e65157 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Bas van de Waterbeemd Gijsbert Zomer Patricia Kaaijk Nicole Ruiterkamp René H Wijffels Germie P J M van den Dobbelsteen Leo A van der Pol Improved production process for native outer membrane vesicle vaccine against Neisseria meningitidis.
description	An improved detergent-free process has been developed to produce vaccine based on native outer membrane vesicles (NOMV) against Neisseria meningitidis serogroup B. Performance was evaluated with the NonaMen vaccine concept, which provides broad coverage based on nine distinct PorA antigens. Scalable aseptic equipment was implemented, replacing undesirable steps like ultracentrifugation, inactivation with phenol, and the use of preservatives. The resulting process is more consistent and gives a higher yield than published reference processes, enabling NOMV production at commercial scale. Product quality met preliminary specifications for 9 consecutive batches, and an ongoing study confirmed real-time stability up to 12 months after production. As the NOMV had low endotoxic activity and induced high bactericidal titres in mice, they are expected to be safe and effective in humans. The production process is not limited to NonaMen and may be applicable for other N. meningitidis serogroups and other gram-negative pathogens. The current results therefore facilitate the late-stage development and clinical evaluation of NOMV vaccines.
format	article
author	Bas van de Waterbeemd Gijsbert Zomer Patricia Kaaijk Nicole Ruiterkamp René H Wijffels Germie P J M van den Dobbelsteen Leo A van der Pol
author_facet	Bas van de Waterbeemd Gijsbert Zomer Patricia Kaaijk Nicole Ruiterkamp René H Wijffels Germie P J M van den Dobbelsteen Leo A van der Pol
author_sort	Bas van de Waterbeemd
title	Improved production process for native outer membrane vesicle vaccine against Neisseria meningitidis.
title_short	Improved production process for native outer membrane vesicle vaccine against Neisseria meningitidis.
title_full	Improved production process for native outer membrane vesicle vaccine against Neisseria meningitidis.
title_fullStr	Improved production process for native outer membrane vesicle vaccine against Neisseria meningitidis.
title_full_unstemmed	Improved production process for native outer membrane vesicle vaccine against Neisseria meningitidis.
title_sort	improved production process for native outer membrane vesicle vaccine against neisseria meningitidis.
publisher	Public Library of Science (PLoS)
publishDate	2013
url	https://doaj.org/article/a7aca8616ff141fd93cc85f4a668c728
work_keys_str_mv	AT basvandewaterbeemd improvedproductionprocessfornativeoutermembranevesiclevaccineagainstneisseriameningitidis AT gijsbertzomer improvedproductionprocessfornativeoutermembranevesiclevaccineagainstneisseriameningitidis AT patriciakaaijk improvedproductionprocessfornativeoutermembranevesiclevaccineagainstneisseriameningitidis AT nicoleruiterkamp improvedproductionprocessfornativeoutermembranevesiclevaccineagainstneisseriameningitidis AT renehwijffels improvedproductionprocessfornativeoutermembranevesiclevaccineagainstneisseriameningitidis AT germiepjmvandendobbelsteen improvedproductionprocessfornativeoutermembranevesiclevaccineagainstneisseriameningitidis AT leoavanderpol improvedproductionprocessfornativeoutermembranevesiclevaccineagainstneisseriameningitidis
_version_	1718423054499971072

Improved production process for native outer membrane vesicle vaccine against Neisseria meningitidis.

Ejemplares similares