Publications by authors named "Shweta Mapari"

This work describes Part 2 of multi-dose formulation development of a Human Papillomavirus (HPV) Virus-Like Particle (VLP) based 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).

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Article Synopsis
  • Developing effective multi-dose subunit vaccines is tough due to the destabilizing effects of antimicrobial preservatives on protein antigens.
  • This study focused on Human Papillomavirus (HPV) Virus-Like Particles (VLPs), testing various lower-concentration combinations of preservatives to balance antimicrobial action and antigen stability.
  • Two screening methods, one-factor-at-a-time and statistical design-of-experiments, were employed, ultimately identifying 20 promising multi-dose vaccine formulations for further testing in long-term stability studies.
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Introducing multi-dose formulations of Human Papillomavirus (HPV) vaccines will reduce costs and enable improved global vaccine coverage, especially in low- and middle-income countries. This work describes the development of key analytical methods later utilized for HPV vaccine multi-dose formulation development. First, down-selection of physicochemical methods suitable for multi-dose formulation development of four HPV (6, 11, 16, and 18) Virus-Like Particles (VLPs) adsorbed to an aluminum adjuvant (Alhydrogel®, AH) was performed.

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