Bacteriophage Production in Compliance with Regulatory Requirements

Autor: Gilbert Verbeken, Jean-Paul Pirnay, Daniel De Vos, Maia Merabishvili, Hilde Van Raemdonck
Rok vydání: 2017
Předmět:
Zdroj: Methods in Molecular Biology ISBN: 9781493973941
DOI: 10.1007/978-1-4939-7395-8_18
Popis: In this chapter we review bacteriophage production requirements to help institutions, which wish to manufacture bacteriophage products for human use in compliance with the applicable regulatory expectancies, defining production processes and implementing relevant controls ensuring quality, safety, and efficacy of the final products. The information disclosed in this chapter can also serve as a basis for discussions with competent authorities regarding the development of expedited bacteriophage product development and licensing pathways, including relevant and pragmatic requirements, and allowing for the full exploitation of bacteriophages as natural controllers of bacterial populations.
Databáze: OpenAIRE