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1
Multi-dose Formulation Development for a Quadrivalent Human..:
Sharma, Nitya
;
Jerajani, Kaushal
;
Wan, Ying
...
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 antimicro.... , 2022
Link:
http://hdl.handle.net/1808/33673
RT Journal T1
Multi-dose Formulation Development for a Quadrivalent Human Papillomavirus Virus-Like Particle-Based Vaccine: Part II- Real-time and Accelerated Stability Studies (Dataset)
UL https://suche.suub.uni-bremen.de/peid=base-ftunivkansas:oai:kuscholarworks.ku.edu:1808_33673&Exemplar=1&LAN=DE A1 Sharma, Nitya A1 Jerajani, Kaushal A1 Wan, Ying A1 Kumru, Ozan S A1 Pullagurla, Swathi R A1 Ogun, Oluwadara A1 Mapari, Shweta A1 Brendle, Sarah A1 Christensen, Neil D A1 Batwal, Saurabh A1 Mahedvi, Mustafa A1 Rao, Harish A1 Dogar, Vikas A1 Chandrasekharan, Rahul A1 Shaligram, Umesh A1 Volkin, David B A1 Joshi, Sangeeta B PB Elsevier YR 2022 K1 Vaccine K1 Human Papillomavirus K1 Virus-Like Particles K1 Multi-dose K1 Formulations K1 Preservatives K1 Stability JF 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 antimicro... LK http://hdl.handle.net/1808/33673 DO http://hdl.handle.net/1808/33673 SF ELIB - SuUB Bremen
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