Publication

GMP manufacturing of Vvax001, a therapeutic anti-HPV vaccine based on recombinant viral particles

Jorritsma-Smit, A., van Zanten, C. J., Schoemaker, J., Meulenberg, J. J. M., Touw, D. J., Kosterink, J. G. W., Nijman, H. W., Daemen, T. & Allersma, D. P., 15-Feb-2020, In : European Journal of Pharmaceutical Sciences. 143, 8 p., 105096.

Research output: Contribution to journalArticleAcademicpeer-review

APA

Jorritsma-Smit, A., van Zanten, C. J., Schoemaker, J., Meulenberg, J. J. M., Touw, D. J., Kosterink, J. G. W., Nijman, H. W., Daemen, T., & Allersma, D. P. (2020). GMP manufacturing of Vvax001, a therapeutic anti-HPV vaccine based on recombinant viral particles. European Journal of Pharmaceutical Sciences, 143, [105096]. https://doi.org/10.1016/j.ejps.2019.105096

Author

Jorritsma-Smit, Annelies ; van Zanten, Coba J ; Schoemaker, Jolande ; Meulenberg, Janneke J M ; Touw, Daan J ; Kosterink, Jos G W ; Nijman, Hans W ; Daemen, Toos ; Allersma, Derk P. / GMP manufacturing of Vvax001, a therapeutic anti-HPV vaccine based on recombinant viral particles. In: European Journal of Pharmaceutical Sciences. 2020 ; Vol. 143.

Harvard

Jorritsma-Smit, A, van Zanten, CJ, Schoemaker, J, Meulenberg, JJM, Touw, DJ, Kosterink, JGW, Nijman, HW, Daemen, T & Allersma, DP 2020, 'GMP manufacturing of Vvax001, a therapeutic anti-HPV vaccine based on recombinant viral particles', European Journal of Pharmaceutical Sciences, vol. 143, 105096. https://doi.org/10.1016/j.ejps.2019.105096

Standard

GMP manufacturing of Vvax001, a therapeutic anti-HPV vaccine based on recombinant viral particles. / Jorritsma-Smit, Annelies; van Zanten, Coba J; Schoemaker, Jolande; Meulenberg, Janneke J M; Touw, Daan J; Kosterink, Jos G W; Nijman, Hans W; Daemen, Toos; Allersma, Derk P.

In: European Journal of Pharmaceutical Sciences, Vol. 143, 105096, 15.02.2020.

Research output: Contribution to journalArticleAcademicpeer-review

Vancouver

Jorritsma-Smit A, van Zanten CJ, Schoemaker J, Meulenberg JJM, Touw DJ, Kosterink JGW et al. GMP manufacturing of Vvax001, a therapeutic anti-HPV vaccine based on recombinant viral particles. European Journal of Pharmaceutical Sciences. 2020 Feb 15;143. 105096. https://doi.org/10.1016/j.ejps.2019.105096


BibTeX

@article{407cb89843fc48718544fcd448e4e608,
title = "GMP manufacturing of Vvax001, a therapeutic anti-HPV vaccine based on recombinant viral particles",
abstract = "Therapeutic vaccination is being explored as a treatment strategy for the treatment of patients with primary or metastatic tumours. We developed a vaccine targeted to Human papillomavirus (HPV)-induced tumours based on recombinant Semliki Forest virus (rSFV) encoding a fusion protein of the E6 and E7 proteins of HPV type 16. To enable a phase I clinical trial with this vaccine, Vvax001, a Good Manufacturing Practice (GMP)-compliant manufacturing process was set up and clinical material was produced. Upstream production of the clinical material resulted in viral titers from 2.4 × 107 to 1.3 × 109 infectious particles/ mL in the harvest. The total volume of 6.0 liter crude virus was purified in 13 consecutive downstream purification runs. The mean titer after purification was 4.0 × 108 infectious particles/ mL and the mean recovery was 19%. Finally, clinical material was filled at a target concentration of 1.25 × 108 infectious particles/mL. Release testing included tests for viral titer and virus identity, biological activity, sterility, bacterial endotoxins, adventitious viruses and absence of replication competent virus. The product complied with all specifications and was released for use as an investigational medicinal product. This is the first GMP production process developed for a SFV-based therapeutic vaccine. The vaccine, Vvax001 is targeted to HPV and has shown promising results in preclinical studies. The GMP-produced Vvax001 material met the quality criteria and was of sufficient quantity to enable assessment of its immunogenicity, safety and efficacy in a clinical setting.",
keywords = "GMP, ATMP, Semliki Forest Virus, recombinant viral particles, vaccine, Human Papilloma Virus, SEMLIKI-FOREST-VIRUS, HUMAN-PAPILLOMAVIRUS, FUSION PROTEIN, IMMUNIZATION, INFECTION, EFFICACY, CANCERS, CELLS, MODEL, E6",
author = "Annelies Jorritsma-Smit and {van Zanten}, {Coba J} and Jolande Schoemaker and Meulenberg, {Janneke J M} and Touw, {Daan J} and Kosterink, {Jos G W} and Nijman, {Hans W} and Toos Daemen and Allersma, {Derk P}",
note = "Copyright {\textcopyright} 2019. Published by Elsevier B.V.",
year = "2020",
month = feb,
day = "15",
doi = "10.1016/j.ejps.2019.105096",
language = "English",
volume = "143",
journal = "European Journal of Pharmaceutical Sciences",
issn = "0928-0987",
publisher = "ELSEVIER SCIENCE BV",

}

RIS

TY - JOUR

T1 - GMP manufacturing of Vvax001, a therapeutic anti-HPV vaccine based on recombinant viral particles

AU - Jorritsma-Smit, Annelies

AU - van Zanten, Coba J

AU - Schoemaker, Jolande

AU - Meulenberg, Janneke J M

AU - Touw, Daan J

AU - Kosterink, Jos G W

AU - Nijman, Hans W

AU - Daemen, Toos

AU - Allersma, Derk P

N1 - Copyright © 2019. Published by Elsevier B.V.

PY - 2020/2/15

Y1 - 2020/2/15

N2 - Therapeutic vaccination is being explored as a treatment strategy for the treatment of patients with primary or metastatic tumours. We developed a vaccine targeted to Human papillomavirus (HPV)-induced tumours based on recombinant Semliki Forest virus (rSFV) encoding a fusion protein of the E6 and E7 proteins of HPV type 16. To enable a phase I clinical trial with this vaccine, Vvax001, a Good Manufacturing Practice (GMP)-compliant manufacturing process was set up and clinical material was produced. Upstream production of the clinical material resulted in viral titers from 2.4 × 107 to 1.3 × 109 infectious particles/ mL in the harvest. The total volume of 6.0 liter crude virus was purified in 13 consecutive downstream purification runs. The mean titer after purification was 4.0 × 108 infectious particles/ mL and the mean recovery was 19%. Finally, clinical material was filled at a target concentration of 1.25 × 108 infectious particles/mL. Release testing included tests for viral titer and virus identity, biological activity, sterility, bacterial endotoxins, adventitious viruses and absence of replication competent virus. The product complied with all specifications and was released for use as an investigational medicinal product. This is the first GMP production process developed for a SFV-based therapeutic vaccine. The vaccine, Vvax001 is targeted to HPV and has shown promising results in preclinical studies. The GMP-produced Vvax001 material met the quality criteria and was of sufficient quantity to enable assessment of its immunogenicity, safety and efficacy in a clinical setting.

AB - Therapeutic vaccination is being explored as a treatment strategy for the treatment of patients with primary or metastatic tumours. We developed a vaccine targeted to Human papillomavirus (HPV)-induced tumours based on recombinant Semliki Forest virus (rSFV) encoding a fusion protein of the E6 and E7 proteins of HPV type 16. To enable a phase I clinical trial with this vaccine, Vvax001, a Good Manufacturing Practice (GMP)-compliant manufacturing process was set up and clinical material was produced. Upstream production of the clinical material resulted in viral titers from 2.4 × 107 to 1.3 × 109 infectious particles/ mL in the harvest. The total volume of 6.0 liter crude virus was purified in 13 consecutive downstream purification runs. The mean titer after purification was 4.0 × 108 infectious particles/ mL and the mean recovery was 19%. Finally, clinical material was filled at a target concentration of 1.25 × 108 infectious particles/mL. Release testing included tests for viral titer and virus identity, biological activity, sterility, bacterial endotoxins, adventitious viruses and absence of replication competent virus. The product complied with all specifications and was released for use as an investigational medicinal product. This is the first GMP production process developed for a SFV-based therapeutic vaccine. The vaccine, Vvax001 is targeted to HPV and has shown promising results in preclinical studies. The GMP-produced Vvax001 material met the quality criteria and was of sufficient quantity to enable assessment of its immunogenicity, safety and efficacy in a clinical setting.

KW - GMP

KW - ATMP

KW - Semliki Forest Virus

KW - recombinant viral particles

KW - vaccine

KW - Human Papilloma Virus

KW - SEMLIKI-FOREST-VIRUS

KW - HUMAN-PAPILLOMAVIRUS

KW - FUSION PROTEIN

KW - IMMUNIZATION

KW - INFECTION

KW - EFFICACY

KW - CANCERS

KW - CELLS

KW - MODEL

KW - E6

U2 - 10.1016/j.ejps.2019.105096

DO - 10.1016/j.ejps.2019.105096

M3 - Article

C2 - 31669389

VL - 143

JO - European Journal of Pharmaceutical Sciences

JF - European Journal of Pharmaceutical Sciences

SN - 0928-0987

M1 - 105096

ER -

ID: 100909713