Assessment of the impact of manufacturing changes on the physicochemical properties of the recombinant vaccine carrier ExoProtein A.
ADP Ribose Transferases
/ chemistry
Amino Acid Sequence
Animals
Bacterial Toxins
/ chemistry
Chemical Phenomena
Epitopes
/ immunology
Exotoxins
/ chemistry
Humans
Immunogenicity, Vaccine
Mice
Peptides
/ immunology
Protein Processing, Post-Translational
Pseudomonas Infections
/ prevention & control
Pseudomonas Vaccines
/ chemistry
Recombinant Proteins
/ chemistry
Spectrum Analysis
Vaccines, Synthetic
/ chemistry
Virulence Factors
/ chemistry
Pseudomonas aeruginosa Exotoxin A
ExoProtein A
Host cell protein
Malaria
Mass spectrometry
Mixed-mode chromatography
Purification
Vaccine
Vaccine carrier
Journal
Vaccine
ISSN: 1873-2518
Titre abrégé: Vaccine
Pays: Netherlands
ID NLM: 8406899
Informations de publication
Date de publication:
10 09 2019
10 09 2019
Historique:
received:
04
05
2018
revised:
06
09
2018
accepted:
16
09
2018
pubmed:
29
9
2018
medline:
24
7
2020
entrez:
29
9
2018
Statut:
ppublish
Résumé
Efforts to develop a vaccine for the elimination of malaria include the use of carrier proteins to assemble monomeric antigens into nanoparticles to maximize immunogenicity. Recombinant ExoProtein A (EPA) is a detoxified form of Pseudomonas aeruginosa Exotoxin A which has been used as a carrier in the conjugate vaccine field. A pilot-scale process developed for purification of EPA yielded product that consistently approached a preset upper limit for host cell protein (HCP) content per human dose. To minimize the risk of bulk material exceeding the specification, the purification process was redeveloped using mixed-mode chromatography resins. Purified EPA derived from the primary and redeveloped processes were comparable following full biochemical and biophysical characterization. However, using a process specific immunoassay, the HCP content was shown to decrease from a range of 0.14-0.24% w/w of total protein to below the level of detection with the revised process. The improved process reproducibly yields EPA with highly similar quality characteristics as the original process but with an improved profile for the HCP content.
Identifiants
pubmed: 30262247
pii: S0264-410X(18)31297-0
doi: 10.1016/j.vaccine.2018.09.037
pmc: PMC6525083
mid: NIHMS1009959
pii:
doi:
Substances chimiques
Bacterial Toxins
0
Epitopes
0
Exotoxins
0
Peptides
0
Pseudomonas Vaccines
0
Recombinant Proteins
0
Vaccines, Synthetic
0
Virulence Factors
0
ADP Ribose Transferases
EC 2.4.2.-
Types de publication
Journal Article
Research Support, N.I.H., Intramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
5762-5769Subventions
Organisme : Intramural NIH HHS
ID : Z99 AI999999
Pays : United States
Informations de copyright
Published by Elsevier Ltd.
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