Pharmaceutical Product Manufacturing Readiness Levels
- Authors: Pyatigorsky A.M.1, Brkich G.E.2, Beregovykh V.V.2, Pyatigorskaya N.V.2, Zyryanov O.A.2, Kuznetsov A.O.2
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Affiliations:
- Institute of Biomedical Chemistry
- I.M. Sechenov First Moscow State Medical University (Sechenov University)
- Issue: Vol 80, No 2 (2025)
- Pages: 138-145
- Section: PHARMACOLOGY: CURRENT ISSUES
- URL: https://ogarev-online.ru/vramn/article/view/310203
- DOI: https://doi.org/10.15690/vramn18036
- ID: 310203
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Abstract
With a high level of fundamental research, there is a gap between fundamental and applied research, and there is a discrepancy between the proposed research results and possible integration into industrial production cycles. Within the life cycle of a pharmaceutical product, reliable processes are the foundation for the successful operation of the enterprise. The duration of development of pharmaceutical products and projects for their implementation require the involvement of significant resources and are associated with significant risks. Starting from the earliest stages of project implementation, it is advisable to use universal, fairly simple indicators and metrics that do not depend on the type of technology and systems being developed, which allow for an adequate assessment of their current development. The production readiness level is a unified parameter used as a tool for assessing how close the results of the project’s technology readiness are to market expectations. It includes measuring the maturity of the technologies/product being developed and will allow you to quickly assess the “maturity” of the selected portfolio, assess the current and desired future of the project, improve the quality of planning, implementation and sustainability of the project.
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##article.viewOnOriginalSite##About the authors
Alexander M. Pyatigorsky
Institute of Biomedical Chemistry
Email: zurianov2009@gmail.com
ORCID iD: 0000-0001-6671-5832
SPIN-code: 3852-4330
Scopus Author ID: 57203038451
Head of the Research and Production Department of the Research Institute of Biomedical Chemistry Named after V.N. Orekhovich
Russian Federation, MoscowGalina E. Brkich
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Email: zurianov2009@gmail.com
ORCID iD: 0000-0002-3469-9062
SPIN-code: 6677-0344
Scopus Author ID: 15076643000
PhD of Pharmaceutical Sciences, Assistant Professor
Russian Federation, 8 bldg 2, Trubetckaya str., 119048, MoscowValery V. Beregovykh
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Email: zurianov2009@gmail.com
ORCID iD: 0000-0002-0210-4570
SPIN-code: 5940-7554
Scopus Author ID: 57926496800
PhD of Technical Sciences, Professor, Academician of the RAS
Russian Federation, 8 bldg 2, Trubetckaya str., 119048, MoscowNatalia V. Pyatigorskaya
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Email: zurianov2009@gmail.com
ORCID iD: 0000-0003-4901-4625
SPIN-code: 8128-1725
Scopus Author ID: 55640443500
PhD of Pharmaceutical Sciences, Professor, Corresponding Member of the RAS
Russian Federation, 8 bldg 2, Trubetckaya str., 119048, MoscowOleg A. Zyryanov
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Author for correspondence.
Email: zurianov2009@gmail.com
ORCID iD: 0000-0001-9038-8720
SPIN-code: 7658-8201
Scopus Author ID: 57214230137
PhD of Pharmaceutical Sciences
Russian Federation, 8 bldg 2, Trubetckaya str., 119048, MoscowAndrey O. Kuznetsov
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Email: zurianov2009@gmail.com
ORCID iD: 0009-0009-2125-1101
SPIN-code: 9437-1452
Scopus Author ID: 58542955200
Master’s Degree 2nd year Studen
Russian Federation, 8 bldg 2, Trubetckaya str., 119048, MoscowReferences
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