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Production of a high purity, C-tagged hepatitis B surface antigen fusion protein VLP vaccine for malaria expressed in Pichia pastoris under cGMP conditions.
Mukhopadhyay, Ekta; Brod, Florian; Angell-Manning, Philip; Green, Nicola; Tarrant, Richard D; Detmers, Frank J; Bolam, Emma J; Baleanu, Ioana N; Hobson, Mark; Whale, Gary; Morris, Susan J; Ashfield, Rebecca; Gilbert, Sarah C; Jin, Jing; Draper, Simon J; Moyle, Sarah P; Berrie, Eleanor L; Hill, Adrian V S.
Afiliación
  • Mukhopadhyay E; Clinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Brod F; The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Angell-Manning P; Clinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Green N; Clinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Tarrant RD; Clinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Detmers FJ; Thermo Fisher Scientific, Leiden, The Netherlands.
  • Bolam EJ; Clinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Baleanu IN; Clinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Hobson M; Clinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Whale G; Clinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Morris SJ; The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Ashfield R; The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Gilbert SC; The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Jin J; The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Draper SJ; The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Moyle SP; Clinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Berrie EL; Clinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Hill AVS; The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Biotechnol Bioeng ; 119(10): 2784-2793, 2022 10.
Article en En | MEDLINE | ID: mdl-35822551
ABSTRACT
Virus-like particles (VLPs) induce strong humoral and cellular responses and have formed the basis of some currently licensed vaccines. Here, we present the method used for the production of R21, a VLP-based anti-sporozoite malaria vaccine, under current Clinical Good Manufacturing Practice regulations (cGMP). Previous preclinical studies in BALB/c mice showed that R21 produced almost complete protection against sporozoite challenge with transgenic Plasmodium berghei parasites. Here, we have modified the preclinical production process to enable the production of sufficient quantities of highly pure, clinical-grade material for use in human clinical trials. The R21 construct was re-engineered to include a C-tag to allow affinity-based separation from the major contaminant alcohol oxidase 1 (AOX 1, ~74 kDa). To our knowledge, this is the first use of C-tag technology to purify a VLP vaccine candidate for use in human clinical trials. The R21 vaccine has shown high-level efficacy in an African Phase IIb trial, and multiple clinical trials are underway to assess the safety and efficacy of the vaccine. Our findings support the future use of C-tag platform technologies to enable cGMP-compliant biomanufacturing of high purity yeast-expressed VLP-based vaccines for early phase clinical trials when clinical grade material is required in smaller quantities in a quick time frame.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacunas Virales / Vacunas contra la Malaria / Saccharomycetales / Vacunas de Partículas Similares a Virus / Malaria Límite: Animals / Humans Idioma: En Revista: Biotechnol Bioeng Año: 2022 Tipo del documento: Article País de afiliación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacunas Virales / Vacunas contra la Malaria / Saccharomycetales / Vacunas de Partículas Similares a Virus / Malaria Límite: Animals / Humans Idioma: En Revista: Biotechnol Bioeng Año: 2022 Tipo del documento: Article País de afiliación: Reino Unido