Bacteriophage Production in Compliance with Regulatory Requirements
Autor: | Gilbert Verbeken, Jean-Paul Pirnay, Daniel De Vos, Maia Merabishvili, Hilde Van Raemdonck |
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Rok vydání: | 2017 |
Předmět: |
0301 basic medicine
biology business.industry media_common.quotation_subject 030106 microbiology biology.organism_classification Compliance (psychology) Bacteriophage 03 medical and health sciences Bacteriophage Therapy Risk analysis (engineering) Human use New product development Production (economics) Quality (business) business media_common |
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 |
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