Cargando…

Pilot scale production of the vaccine adjuvant Proteoliposome derived Cochleates (AFCo1) from Neisseria meningitidis serogroup B

The use of new adjuvants in vaccine formulations is a subject of current research. Only few parenteral adjuvants have been licensed. We have developed a mucosal and parenteral adjuvant known as AFCo1 (Adjuvant Finlay Cochleate 1, derived from proteoliposomes of N. meningitidis B) using a dialysis pr...

Descripción completa

Detalles Bibliográficos
Autores principales: Zayas, Caridad, González, Domingo, Acevedo, Reinaldo, del Campo, Judith, Lastre, Miriam, González, Elizabeth, Romeu, Belkis, Cuello, Maribel, Balboa, Julio, Cabrera, Osmir, Guilherme, Luisa, Pérez, Oliver
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3582446/
https://www.ncbi.nlm.nih.gov/pubmed/23458578
http://dx.doi.org/10.1186/1471-2172-14-S1-S4
_version_ 1782260564256358400
author Zayas, Caridad
González, Domingo
Acevedo, Reinaldo
del Campo, Judith
Lastre, Miriam
González, Elizabeth
Romeu, Belkis
Cuello, Maribel
Balboa, Julio
Cabrera, Osmir
Guilherme, Luisa
Pérez, Oliver
author_facet Zayas, Caridad
González, Domingo
Acevedo, Reinaldo
del Campo, Judith
Lastre, Miriam
González, Elizabeth
Romeu, Belkis
Cuello, Maribel
Balboa, Julio
Cabrera, Osmir
Guilherme, Luisa
Pérez, Oliver
author_sort Zayas, Caridad
collection PubMed
description The use of new adjuvants in vaccine formulations is a subject of current research. Only few parenteral adjuvants have been licensed. We have developed a mucosal and parenteral adjuvant known as AFCo1 (Adjuvant Finlay Cochleate 1, derived from proteoliposomes of N. meningitidis B) using a dialysis procedure to produce them on lab scale. The immunogenicity of the AFCo1 produced by dialysis has been already evaluated, but it was necessary to demonstrate the feasibility of a larger-scale manufacturing process. Therefore, we used a crossflow diafiltration system (CFS) that allows easy scale up to obtain large batches in an aseptic environment. The aim of this work was to produce AFCo1 on pilot scale, while conserving the adjuvant properties. The proteoliposomes (raw material) were resuspended in a buffer containing sodium deoxycholate and were transformed into AFCo1 under the action of a calcium forming buffer. The detergent was removed from the protein solution by diafiltration to a constant volume. In this CFS, we used a hollow fiber cartridge from Amicon (polysulfona cartridge of 10 kDa porosity, 1mm channel diameter of fiber and 0.45 m(2) area of filtration), allowing production of a batch of up to 20 L. AFCo1 were successfully produced by tangential filtration to pilot scale. The batch passed preliminary stability tests. Nasal immunization of BALB/c mice, induced specific saliva IgA and serum IgG. The induction of Th1 responses were demonstrated by the induction of IgG2a, IFNγ and not IL-5. The adjuvant action over Neisseria (self) antigens and with co-administered (heterologous) antigens such as ovalbumin and a synthetic peptide from haemolytic Streptococcus B was also demonstrated.
format Online
Article
Text
id pubmed-3582446
institution National Center for Biotechnology Information
language English
publishDate 2013
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-35824462013-03-08 Pilot scale production of the vaccine adjuvant Proteoliposome derived Cochleates (AFCo1) from Neisseria meningitidis serogroup B Zayas, Caridad González, Domingo Acevedo, Reinaldo del Campo, Judith Lastre, Miriam González, Elizabeth Romeu, Belkis Cuello, Maribel Balboa, Julio Cabrera, Osmir Guilherme, Luisa Pérez, Oliver BMC Immunol Proceedings The use of new adjuvants in vaccine formulations is a subject of current research. Only few parenteral adjuvants have been licensed. We have developed a mucosal and parenteral adjuvant known as AFCo1 (Adjuvant Finlay Cochleate 1, derived from proteoliposomes of N. meningitidis B) using a dialysis procedure to produce them on lab scale. The immunogenicity of the AFCo1 produced by dialysis has been already evaluated, but it was necessary to demonstrate the feasibility of a larger-scale manufacturing process. Therefore, we used a crossflow diafiltration system (CFS) that allows easy scale up to obtain large batches in an aseptic environment. The aim of this work was to produce AFCo1 on pilot scale, while conserving the adjuvant properties. The proteoliposomes (raw material) were resuspended in a buffer containing sodium deoxycholate and were transformed into AFCo1 under the action of a calcium forming buffer. The detergent was removed from the protein solution by diafiltration to a constant volume. In this CFS, we used a hollow fiber cartridge from Amicon (polysulfona cartridge of 10 kDa porosity, 1mm channel diameter of fiber and 0.45 m(2) area of filtration), allowing production of a batch of up to 20 L. AFCo1 were successfully produced by tangential filtration to pilot scale. The batch passed preliminary stability tests. Nasal immunization of BALB/c mice, induced specific saliva IgA and serum IgG. The induction of Th1 responses were demonstrated by the induction of IgG2a, IFNγ and not IL-5. The adjuvant action over Neisseria (self) antigens and with co-administered (heterologous) antigens such as ovalbumin and a synthetic peptide from haemolytic Streptococcus B was also demonstrated. BioMed Central 2013-02-25 /pmc/articles/PMC3582446/ /pubmed/23458578 http://dx.doi.org/10.1186/1471-2172-14-S1-S4 Text en Copyright ©2013 Zayas et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Proceedings
Zayas, Caridad
González, Domingo
Acevedo, Reinaldo
del Campo, Judith
Lastre, Miriam
González, Elizabeth
Romeu, Belkis
Cuello, Maribel
Balboa, Julio
Cabrera, Osmir
Guilherme, Luisa
Pérez, Oliver
Pilot scale production of the vaccine adjuvant Proteoliposome derived Cochleates (AFCo1) from Neisseria meningitidis serogroup B
title Pilot scale production of the vaccine adjuvant Proteoliposome derived Cochleates (AFCo1) from Neisseria meningitidis serogroup B
title_full Pilot scale production of the vaccine adjuvant Proteoliposome derived Cochleates (AFCo1) from Neisseria meningitidis serogroup B
title_fullStr Pilot scale production of the vaccine adjuvant Proteoliposome derived Cochleates (AFCo1) from Neisseria meningitidis serogroup B
title_full_unstemmed Pilot scale production of the vaccine adjuvant Proteoliposome derived Cochleates (AFCo1) from Neisseria meningitidis serogroup B
title_short Pilot scale production of the vaccine adjuvant Proteoliposome derived Cochleates (AFCo1) from Neisseria meningitidis serogroup B
title_sort pilot scale production of the vaccine adjuvant proteoliposome derived cochleates (afco1) from neisseria meningitidis serogroup b
topic Proceedings
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3582446/
https://www.ncbi.nlm.nih.gov/pubmed/23458578
http://dx.doi.org/10.1186/1471-2172-14-S1-S4
work_keys_str_mv AT zayascaridad pilotscaleproductionofthevaccineadjuvantproteoliposomederivedcochleatesafco1fromneisseriameningitidisserogroupb
AT gonzalezdomingo pilotscaleproductionofthevaccineadjuvantproteoliposomederivedcochleatesafco1fromneisseriameningitidisserogroupb
AT acevedoreinaldo pilotscaleproductionofthevaccineadjuvantproteoliposomederivedcochleatesafco1fromneisseriameningitidisserogroupb
AT delcampojudith pilotscaleproductionofthevaccineadjuvantproteoliposomederivedcochleatesafco1fromneisseriameningitidisserogroupb
AT lastremiriam pilotscaleproductionofthevaccineadjuvantproteoliposomederivedcochleatesafco1fromneisseriameningitidisserogroupb
AT gonzalezelizabeth pilotscaleproductionofthevaccineadjuvantproteoliposomederivedcochleatesafco1fromneisseriameningitidisserogroupb
AT romeubelkis pilotscaleproductionofthevaccineadjuvantproteoliposomederivedcochleatesafco1fromneisseriameningitidisserogroupb
AT cuellomaribel pilotscaleproductionofthevaccineadjuvantproteoliposomederivedcochleatesafco1fromneisseriameningitidisserogroupb
AT balboajulio pilotscaleproductionofthevaccineadjuvantproteoliposomederivedcochleatesafco1fromneisseriameningitidisserogroupb
AT cabreraosmir pilotscaleproductionofthevaccineadjuvantproteoliposomederivedcochleatesafco1fromneisseriameningitidisserogroupb
AT guilhermeluisa pilotscaleproductionofthevaccineadjuvantproteoliposomederivedcochleatesafco1fromneisseriameningitidisserogroupb
AT perezoliver pilotscaleproductionofthevaccineadjuvantproteoliposomederivedcochleatesafco1fromneisseriameningitidisserogroupb