title: Implementation of QbD for the development of a vaccine candidate.
abstract: This case study provides an example of how Quality by Design (QbD) principles were applied to accelerate process development to manufacture a vaccine candidate at commercial scale. By leveraging an existing manufacturing platform process, a risk assessment was used to differentiate process parameters that could be defined using a combination of scientific and historical manufacturing knowledge from those that merited additional process characterization by experimentation. Select parameters, and their interactions, were evaluated by a Design of Experiment (DoE) series. This systematic approach required less time and fewer resources and resulted in the definition of a reliable and robust manufacturing process that meets regulatory requirements.
authors.affiliation: Merck Research Laboratories, Merck & Co., Inc, West Point, PA, United States. Electronic address: jennifer.haas@merck.com.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Haas
authors.affiliation: Merck Research Laboratories, Merck & Co., Inc, West Point, PA, United States.
authors.forename: Andrew
authors.initials: A
authors.lastname: Franklin
authors.affiliation: Merck Research Laboratories, Merck & Co., Inc, West Point, PA, United States.
authors.forename: Matthew
authors.initials: M
authors.lastname: Houser
authors.affiliation: Merck Manufacturing Division, Merck & Co., Inc, West Point, PA, United States.
authors.forename: David
authors.initials: D
authors.lastname: Maraldo
authors.affiliation: Merck Research Laboratories, Merck & Co., Inc, West Point, PA, United States.
authors.forename: Mark
authors.initials: M
authors.lastname: Mikola
authors.affiliation: Merck Research Laboratories, Merck & Co., Inc, West Point, PA, United States.
authors.forename: Roberto
authors.initials: R
authors.lastname: Ortiz
authors.affiliation: Merck Research Laboratories, Merck & Co., Inc, West Point, PA, United States.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Sullivan
authors.affiliation: Merck Manufacturing Division, Merck & Co., Inc, West Point, PA, United States.
authors.forename: José M
authors.initials: JM
authors.lastname: Otero
mesh_terms: D005285:Fermentation; D011786:Quality Control; D012107:Research Design; D018570:Risk Assessment; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards*; D014612:Vaccines / Q000592:standards*
chemical_list: D014612:Vaccines
keywords: FMEA; Process development; Quality by Design; Vaccines