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Multi-dose Formulation Development for a Quadrivalent Human Papillomavirus Virus-Like Particle-Based Vaccine: Part II- Real-time and Accelerated Stability Studies (Dataset)
dc.contributor.author | Sharma, Nitya | |
dc.contributor.author | Jerajani, Kaushal | |
dc.contributor.author | Wan, Ying | |
dc.contributor.author | Kumru, Ozan S. | |
dc.contributor.author | Pullagurla, Swathi R. | |
dc.contributor.author | Ogun, Oluwadara | |
dc.contributor.author | Mapari, Shweta | |
dc.contributor.author | Brendle, Sarah | |
dc.contributor.author | Christensen, Neil D. | |
dc.contributor.author | Batwal, Saurabh | |
dc.contributor.author | Mahedvi, Mustafa | |
dc.contributor.author | Rao, Harish | |
dc.contributor.author | Dogar, Vikas | |
dc.contributor.author | Chandrasekharan, Rahul | |
dc.contributor.author | Shaligram, Umesh | |
dc.contributor.author | Volkin, David B. | |
dc.contributor.author | Joshi, Sangeeta B. | |
dc.date.accessioned | 2022-11-21T15:48:09Z | |
dc.date.available | 2022-11-21T15:48:09Z | |
dc.date.issued | 2022-11-21 | |
dc.identifier.citation | This work describes Part 2 of multi-dose formulation development of a Human Papillomavirus (HPV) Virus-Like Particles (VLPs) containing vaccine (see Part 1 in companion paper). Storage stability studies with candidate multi-dose formulations containing individual or combinations of seven different antimicrobial preservatives (APs) were performed with quadrivalent HPV VLP (6, 11, 16, 18) antigens adsorbed to aluminum-salt adjuvant (Alhydrogel®). Real-time (up to two years, 2-8°C) and accelerated (months at 25 and 40°C) stability studies identified eight lead candidates as measured by antigen stability (competitive ELISA employing conformational serotype-specific mAbs), antimicrobial effectiveness (modified European Pharmacopeia assay), total protein content (SDS-PAGE), and AP concentration (RP-UHPLC). The AH-adsorbed HPV18 VLP component was most sensitive to AP-induced destabilization. Optimal quadrivalent antigen storage stability while maintaining antimicrobial effectiveness was observed with 2-phenoxyethanol, benzyl alcohol, chlorobutanol, and 2-phenoxyethanol + benzyl alcohol combination. Interestingly, for single-AP containing multi-dose formulations, this rank-ordering of storage stability did not correlate with previously reported biophysical measurements of AP-induced antigen destabilization. Moreover, other APs (e.g., m-cresol, phenol, parabens) described by others for inclusion in multi-dose HPV VLP formulations showed suboptimal stability. These results suggest that each HPV VLP vaccine candidate (e.g., different serotypes, expression systems, processes, adjuvants) will require customized multi-dose formulation development. | en_US |
dc.identifier.uri | http://hdl.handle.net/1808/33673 | |
dc.description | This is the dataset for the article Multi-dose Formulation Development for a Quadrivalent Human Papillomavirus Virus-Like Particle-Based Vaccine: Part II- Real-time and Accelerated Stability Studies, published in 2022 in the Journal of Pharmaceutical Sciences (Elsevier). | en_US |
dc.description.abstract | This work describes Part 2 of multi-dose formulation development of a Human Papillomavirus (HPV) Virus-Like Particles (VLPs) containing vaccine (see Part 1 in companion paper). Storage stability studies with candidate multi-dose formulations containing individual or combinations of seven different antimicrobial preservatives (APs) were performed with quadrivalent HPV VLP (6, 11, 16, 18) antigens adsorbed to aluminum-salt adjuvant (Alhydrogel®). Real-time (up to two years, 2-8°C) and accelerated (months at 25 and 40°C) stability studies identified eight lead candidates as measured by antigen stability (competitive ELISA employing conformational serotype-specific mAbs), antimicrobial effectiveness (modified European Pharmacopeia assay), total protein content (SDS-PAGE), and AP concentration (RP-UHPLC). The AH-adsorbed HPV18 VLP component was most sensitive to AP-induced destabilization. Optimal quadrivalent antigen storage stability while maintaining antimicrobial effectiveness was observed with 2-phenoxyethanol, benzyl alcohol, chlorobutanol, and 2-phenoxyethanol + benzyl alcohol combination. Interestingly, for single-AP containing multi-dose formulations, this rank-ordering of storage stability did not correlate with previously reported biophysical measurements of AP-induced antigen destabilization. Moreover, other APs (e.g., m-cresol, phenol, parabens) described by others for inclusion in multi-dose HPV VLP formulations showed suboptimal stability. These results suggest that each HPV VLP vaccine candidate (e.g., different serotypes, expression systems, processes, adjuvants) will require customized multi-dose formulation development. | en_US |
dc.publisher | Elsevier | en_US |
dc.subject | Vaccine | en_US |
dc.subject | Human Papillomavirus | en_US |
dc.subject | Virus-Like Particles | en_US |
dc.subject | Multi-dose | en_US |
dc.subject | Formulations | en_US |
dc.subject | Preservatives | en_US |
dc.subject | Stability | en_US |
dc.title | Multi-dose Formulation Development for a Quadrivalent Human Papillomavirus Virus-Like Particle-Based Vaccine: Part II- Real-time and Accelerated Stability Studies (Dataset) | en_US |
dc.type | Dataset | en_US |
kusw.kuauthor | Sharma, Nitya | |
kusw.kuauthor | Jerijani, Kaushal | |
kusw.kudepartment | Pharmaceutical Chemistry | en_US |
dc.identifier.doi | https://doi.org/10.17161/1808.33673 | |
dc.identifier.orcid | https://orcid.org/0000-0002-2714-5352 | en_US |
dc.rights.accessrights | openAccess | en_US |