| Chapter title |
Bacteriophage Production in Compliance with Regulatory Requirements
|
|---|---|
| Chapter number | 18 |
| Book title |
Bacteriophage Therapy
|
| Published in |
Methods in molecular biology, November 2017
|
| DOI | 10.1007/978-1-4939-7395-8_18 |
| Pubmed ID | |
| Book ISBNs |
978-1-4939-7394-1, 978-1-4939-7395-8
|
| Authors |
Jean-Paul Pirnay, Maia Merabishvili, Hilde Van Raemdonck, Daniel De Vos, Gilbert Verbeken, Pirnay, Jean-Paul, Merabishvili, Maia, Van Raemdonck, Hilde, De Vos, Daniel, Verbeken, Gilbert, Raemdonck, Hilde, Vos, Daniel |
| Abstract |
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. |
X Demographics
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| France | 1 | 50% |
| Unknown | 1 | 50% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Science communicators (journalists, bloggers, editors) | 1 | 50% |
| Members of the public | 1 | 50% |
Mendeley readers
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 53 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Bachelor | 9 | 17% |
| Student > Ph. D. Student | 8 | 15% |
| Researcher | 5 | 9% |
| Student > Master | 5 | 9% |
| Other | 4 | 8% |
| Other | 7 | 13% |
| Unknown | 15 | 28% |
| Readers by discipline | Count | As % |
|---|---|---|
| Agricultural and Biological Sciences | 7 | 13% |
| Biochemistry, Genetics and Molecular Biology | 7 | 13% |
| Pharmacology, Toxicology and Pharmaceutical Science | 6 | 11% |
| Engineering | 4 | 8% |
| Medicine and Dentistry | 4 | 8% |
| Other | 7 | 13% |
| Unknown | 18 | 34% |