Good Manufacturing Practices (GMP) manufacturing of advanced therapy medicinal products: A novel tailored model for optimizing performance and estimating costs

Mohamed Abou-El-Enein, Andy Römhild, Daniel Kaiser, Carola Beier, Gerhard Bauer, Hans Dieter Volk, Petra Reinke

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

Background aims. Advanced therapy medicinal products (ATMP) have gained considerable attention in academia due to their therapeutic potential. Good Manufacturing Practice (GMP) principles ensure the quality and sterility of manufacturing these products. We developed a model for estimating the manufacturing costs of cell therapy products and optimizing the performance of academic GMP-facilities. Methods. The 'Clean-Room Technology Assessment Technique' (CTAT) was tested prospectively in the GMP facility of BCRT, Berlin, Germany, then retrospectively in the GMP facility of the University of California-Davis, California, USA. CTAT is a two-level model: level one identifies operational (core) processes and measures their fixed costs; level two identifies production (supporting) processes and measures their variable costs. The model comprises several tools to measure and optimize performance of these processes. Manufacturing costs were itemized using adjusted micro-costing system. Results. CTAT identified GMP activities with strong correlation to the manufacturing process of cell-based products. Building best practice standards allowed for performance improvement and elimination of human errors. The model also demonstrated the unidirectional dependencies that may exist among the core GMP activities. When compared to traditional business models, the CTAT assessment resulted in a more accurate allocation of annual expenses. The estimated expenses were used to set a fee structure for both GMP facilities. A mathematical equation was also developed to provide the final product cost. Conclusions. CTAT can be a useful tool in estimating accurate costs for the ATMPs manufactured in an optimized GMP process. These estimates are useful when analyzing the cost-effectiveness of these novel interventions.

Original languageEnglish (US)
Pages (from-to)362-383
Number of pages22
JournalCytotherapy
Volume15
Issue number3
DOIs
StatePublished - Mar 2013

Fingerprint

Controlled Environment
Biomedical Technology Assessment
Costs and Cost Analysis
Process Assessment (Health Care)
Therapeutics
Fees and Charges
Berlin
Cell- and Tissue-Based Therapy
Practice Guidelines
Infertility
Cost-Benefit Analysis
Germany
Manufacturing and Industrial Facilities

Keywords

  • Advanced therapy medicinal products
  • Clean-room technology
  • Good manufacturing practices
  • Micro-costing
  • Performance optimization

ASJC Scopus subject areas

  • Immunology
  • Immunology and Allergy
  • Molecular Medicine

Cite this

Good Manufacturing Practices (GMP) manufacturing of advanced therapy medicinal products : A novel tailored model for optimizing performance and estimating costs. / Abou-El-Enein, Mohamed; Römhild, Andy; Kaiser, Daniel; Beier, Carola; Bauer, Gerhard; Volk, Hans Dieter; Reinke, Petra.

In: Cytotherapy, Vol. 15, No. 3, 03.2013, p. 362-383.

Research output: Contribution to journalArticle

Abou-El-Enein, Mohamed ; Römhild, Andy ; Kaiser, Daniel ; Beier, Carola ; Bauer, Gerhard ; Volk, Hans Dieter ; Reinke, Petra. / Good Manufacturing Practices (GMP) manufacturing of advanced therapy medicinal products : A novel tailored model for optimizing performance and estimating costs. In: Cytotherapy. 2013 ; Vol. 15, No. 3. pp. 362-383.
@article{7d71e626f0744fdda43e5ed29c914e4d,
title = "Good Manufacturing Practices (GMP) manufacturing of advanced therapy medicinal products: A novel tailored model for optimizing performance and estimating costs",
abstract = "Background aims. Advanced therapy medicinal products (ATMP) have gained considerable attention in academia due to their therapeutic potential. Good Manufacturing Practice (GMP) principles ensure the quality and sterility of manufacturing these products. We developed a model for estimating the manufacturing costs of cell therapy products and optimizing the performance of academic GMP-facilities. Methods. The 'Clean-Room Technology Assessment Technique' (CTAT) was tested prospectively in the GMP facility of BCRT, Berlin, Germany, then retrospectively in the GMP facility of the University of California-Davis, California, USA. CTAT is a two-level model: level one identifies operational (core) processes and measures their fixed costs; level two identifies production (supporting) processes and measures their variable costs. The model comprises several tools to measure and optimize performance of these processes. Manufacturing costs were itemized using adjusted micro-costing system. Results. CTAT identified GMP activities with strong correlation to the manufacturing process of cell-based products. Building best practice standards allowed for performance improvement and elimination of human errors. The model also demonstrated the unidirectional dependencies that may exist among the core GMP activities. When compared to traditional business models, the CTAT assessment resulted in a more accurate allocation of annual expenses. The estimated expenses were used to set a fee structure for both GMP facilities. A mathematical equation was also developed to provide the final product cost. Conclusions. CTAT can be a useful tool in estimating accurate costs for the ATMPs manufactured in an optimized GMP process. These estimates are useful when analyzing the cost-effectiveness of these novel interventions.",
keywords = "Advanced therapy medicinal products, Clean-room technology, Good manufacturing practices, Micro-costing, Performance optimization",
author = "Mohamed Abou-El-Enein and Andy R{\"o}mhild and Daniel Kaiser and Carola Beier and Gerhard Bauer and Volk, {Hans Dieter} and Petra Reinke",
year = "2013",
month = "3",
doi = "10.1016/j.jcyt.2012.09.006",
language = "English (US)",
volume = "15",
pages = "362--383",
journal = "Cytotherapy",
issn = "1465-3249",
publisher = "Informa Healthcare",
number = "3",

}

TY - JOUR

T1 - Good Manufacturing Practices (GMP) manufacturing of advanced therapy medicinal products

T2 - A novel tailored model for optimizing performance and estimating costs

AU - Abou-El-Enein, Mohamed

AU - Römhild, Andy

AU - Kaiser, Daniel

AU - Beier, Carola

AU - Bauer, Gerhard

AU - Volk, Hans Dieter

AU - Reinke, Petra

PY - 2013/3

Y1 - 2013/3

N2 - Background aims. Advanced therapy medicinal products (ATMP) have gained considerable attention in academia due to their therapeutic potential. Good Manufacturing Practice (GMP) principles ensure the quality and sterility of manufacturing these products. We developed a model for estimating the manufacturing costs of cell therapy products and optimizing the performance of academic GMP-facilities. Methods. The 'Clean-Room Technology Assessment Technique' (CTAT) was tested prospectively in the GMP facility of BCRT, Berlin, Germany, then retrospectively in the GMP facility of the University of California-Davis, California, USA. CTAT is a two-level model: level one identifies operational (core) processes and measures their fixed costs; level two identifies production (supporting) processes and measures their variable costs. The model comprises several tools to measure and optimize performance of these processes. Manufacturing costs were itemized using adjusted micro-costing system. Results. CTAT identified GMP activities with strong correlation to the manufacturing process of cell-based products. Building best practice standards allowed for performance improvement and elimination of human errors. The model also demonstrated the unidirectional dependencies that may exist among the core GMP activities. When compared to traditional business models, the CTAT assessment resulted in a more accurate allocation of annual expenses. The estimated expenses were used to set a fee structure for both GMP facilities. A mathematical equation was also developed to provide the final product cost. Conclusions. CTAT can be a useful tool in estimating accurate costs for the ATMPs manufactured in an optimized GMP process. These estimates are useful when analyzing the cost-effectiveness of these novel interventions.

AB - Background aims. Advanced therapy medicinal products (ATMP) have gained considerable attention in academia due to their therapeutic potential. Good Manufacturing Practice (GMP) principles ensure the quality and sterility of manufacturing these products. We developed a model for estimating the manufacturing costs of cell therapy products and optimizing the performance of academic GMP-facilities. Methods. The 'Clean-Room Technology Assessment Technique' (CTAT) was tested prospectively in the GMP facility of BCRT, Berlin, Germany, then retrospectively in the GMP facility of the University of California-Davis, California, USA. CTAT is a two-level model: level one identifies operational (core) processes and measures their fixed costs; level two identifies production (supporting) processes and measures their variable costs. The model comprises several tools to measure and optimize performance of these processes. Manufacturing costs were itemized using adjusted micro-costing system. Results. CTAT identified GMP activities with strong correlation to the manufacturing process of cell-based products. Building best practice standards allowed for performance improvement and elimination of human errors. The model also demonstrated the unidirectional dependencies that may exist among the core GMP activities. When compared to traditional business models, the CTAT assessment resulted in a more accurate allocation of annual expenses. The estimated expenses were used to set a fee structure for both GMP facilities. A mathematical equation was also developed to provide the final product cost. Conclusions. CTAT can be a useful tool in estimating accurate costs for the ATMPs manufactured in an optimized GMP process. These estimates are useful when analyzing the cost-effectiveness of these novel interventions.

KW - Advanced therapy medicinal products

KW - Clean-room technology

KW - Good manufacturing practices

KW - Micro-costing

KW - Performance optimization

UR - http://www.scopus.com/inward/record.url?scp=84875476872&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84875476872&partnerID=8YFLogxK

U2 - 10.1016/j.jcyt.2012.09.006

DO - 10.1016/j.jcyt.2012.09.006

M3 - Article

C2 - 23579061

AN - SCOPUS:84875476872

VL - 15

SP - 362

EP - 383

JO - Cytotherapy

JF - Cytotherapy

SN - 1465-3249

IS - 3

ER -