Abstract
Recent clinical progress in the field of phage therapy has led to an increased demand for pharmaceutical grade bacteriophages, manufactured under Good Manufacturing Practices (GMP) conditions and approved by regulatory agencies. However, even if the development of a common standardized process for phage production seems rational, there are no guidelines to pave to way for manufacturing. This chapter reviews phage therapy through the lens of modern medicinal guidelines. It lists manufacturing strategies that can be used for phage production. Finally, it stands quality controls that can be applied to release phage-based drug products in compliance with the latest regulatory requirements.
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Glossary
- ANSM
-
Agence National de Sécurité des Médicaments et des produits de santé. French drug regulation agency
- CFR
-
Code federal regulations in the USA
- CFU
-
Colony-forming unit
- CRO
-
Contract research organization
- DLS
-
Dynamic light scattering
- DP
-
Drug product, i.e., the final product used in clinical trials or for commercialization
- DS
-
A component of a drug product, such as a phage type in a cocktail
- EMA (previously EMEA)
-
European Medicine Agency
- EOP
-
Efficiency of plating
- EudraLex
-
The body of European Union legislation in the pharmaceutical sector compiled in Volume 1 and Volume 5 of the publication “The rules governing medicinal products in the European Union”
- FDA
-
Food and Drug Administration
- GLP
-
Good Laboratory Practices
- GMO
-
Genetically modified organism
- GMP or cGMP
-
Good manufacturing practices with “c” standing for current, i.e., the latest updated version
- GRAS
-
Generally recognized as safe is a FDA product status (sections 201 and 409 of the Federal Food, Drug, and Cosmetic Act) for food substances or additives, which is delivered according to their safety data package
- HCP
-
Host cell proteins
- ICH
-
International conference on harmonization, leading to international guidelines or procedures, for instance, in the field of technical requirements for registration of pharmaceuticals for human use
- IMPD
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The investigational medicinal product dossier is the basis for approval of clinical trials by the competent authorities, such as regulatory agency(ies) end ethics committee(s) in the EU
- IND
-
In the USA, the investigational new drug dossier is the basis for approval of clinical trials, emergency use (in a situation that does not allow time for submission of an IND in accordance with 21CFR) or treatment (for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions, while the final clinical work and the data review take place) by FDA
- IEX
-
Ion exchange
- IU or EU
-
International unit or enzyme (endotoxin) unit
- MHRA
-
The Medicines and Healthcare Products Regulatory Agency of the United Kingdom
- MCS
-
Master bacteria cell stock
- MPB
-
Master phage bank
- NGS
-
Next-generation DNA/RNA sequencing
- NIAID
-
National Institute of Allergy and Infectious Diseases
- NIH
-
National Institutes of Health
- PCR
-
Polymerase chain reaction
- PFU
-
Plaque-forming unit
- QA
-
Quality assurance is a systematic process to ensure that QC tests are properly performed
- QC
-
Quality control is set of tests to ensure that quality (conformity) of a product is respected. When a drug product belongs to a pharmacopeia, this set of tests and procedures is already precisely described
- RE
-
Restriction enzyme
- RFLP
-
Restriction fragment length polymorphism
- RAPD
-
Random amplified polymorphic DNA
- SEC
-
Size exclusion chromatography
- TEM
-
Transmission electronic microscopy
- UF
-
Ultrafiltration is the filtration of a fluid in order to get rid of the particles that it could contain in suspension
- WHO
-
World Health Organization
- WCS
-
Working bacteria cell stock
- WPB
-
Working phage bank
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Regulski, K., Champion-Arnaud, P., Gabard, J. (2018). Bacteriophage Manufacturing: From Early Twentieth-Century Processes to Current GMP. In: Harper, D., Abedon, S., Burrowes, B., McConville, M. (eds) Bacteriophages. Springer, Cham. https://doi.org/10.1007/978-3-319-40598-8_25-1
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DOI: https://doi.org/10.1007/978-3-319-40598-8_25-1
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