Process modeling in the biopharmaceutical industry

Horner, Marc; Joshi, Shitalkumar; Waghmare, Yogesh

doi:10.1016/b978-0-08-100154-7.00014-4

Cited by 5 publications

(4 citation statements)

References 46 publications

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“…In addition, only a few studies have applied modeling approaches with direct application to pharmaceutical products and process design and analysis [ 13 , 27 ]. Most research efforts were industry-driven and directed toward the incorporation of modeling tools into drug development and production practices, with the purpose of enhancing the process by reducing the cost and time to market of the products [ 14 , 26 ].…”

Section: Resultsmentioning

confidence: 99%

“…After the full-text review, 23 sources, including peer-reviewed articles, conference proceedings, book chapters, and articles from public policy professional centers, were included in the narrative review (Table 1). [11] A Validation Model for the Medical Devices Industry Alexander and Clarkson [12] Early-Stage Biotech Companies: Strategies for Survival and Growth Tsai and Erickson [9] Quality by Design for Biopharmaceuticals Rathore and Winkle [13] A Model-Based Systems Approach to Pharmaceutical Product-Process Design and Analysis Gernaey and Gani [14] The Business Benefits of Quality by Design (QbD) Kourti and Davis [15] Design for FDA: A Predictive Model for the FDA's Decision Time for Medical Devices Medina et al [16] Supporting Medical Device Development: A Standard Product Design Process Model Medina et al [17] Regulatory Approval and Compliances for Biotechnology Products Baylor [18] The Biomanufacturing of Biotechnology Products Conner et al [19] Understanding Pharmaceutical Quality by Design Lawrence et al [20] QbD Implementation in Biotechnological Product Development Studies Aksu et al [21] The Proper Role of the FDA for the 21st Century Briggeman et al [22] 2015 in Review: FDA Approval of New Drugs Kinch [23] The Need for FDA Reform: Four Models Thierer and Wilt [24] Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs Van Norman [1] Drugs and Devices: Comparison of European and US Approval Processes Van Norman [10] Food and Drug Administration Drug Approval Process: A History and Overview Williams [4] Health Options Foreclosed: How the FDA Denies Americans the Benefits of Medical Research Williams et al [3] Modeling in the Quality by Design Environment: Regulatory Requirements and Recommendations for Design Space and Control Strategy Appointment Djuris and Djuric [25] Process Modeling in the Biopharmaceutical Industry Horner et al [26] Optimization of Ion Exchange Sigmoidal Gradients Using Hybrid Models: Implementation of Quality by Design in Analytical Method Development Joshi et al [27]…”

Section: Study Selectionmentioning

confidence: 99%

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Investigating the Food and Drug Administration Biotherapeutics Review and Approval Process: Narrative Review

Olivencia¹,

Sasangohar²

2021

JMIR Form Res

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Background The development, review, and approval process of therapeutic biological products in the United States presents two primary challenges: time and cost. Advancing a biotherapeutic from concept to market may take an average of 12 years, with costs exceeding US $1 billion, and the product may still fail the US Food and Drug Administration (FDA) approval process. Despite the FDA’s practices to expedite the approval of new therapies, seeking FDA approval remains a long, costly, and risky process. Objective The objective of this paper is to explore the factors and gaps related to the FDA review and approval process that contribute to process inefficiencies and complexities as well as proposed methods and solutions to address such gaps. This paper also aims to investigate the available modeling efforts for the FDA approval process of therapeutic biological products. Methods A narrative review of literature was conducted to understand the scope of published knowledge about challenges, opportunities, and specific methods to address the factors and gaps related to the review and approval of new drugs, including therapeutic biological products. Relevant peer-reviewed journal articles, conference proceedings, book chapters, official reports from public policy professional centers, and official reports and guidelines from the FDA were reviewed. Results Of the 23 articles identified in this narrative literature review, none modeled the current FDA review and approval process structure to address issues related to the robustness, reliability, and efficiency of its operations from an external point of view. Although several studies summarize the FDA approval process with clarity, in addition to bringing to light the problems and challenges faced by the regulatory agency, only a few attempts have been made to provide solutions for the problems and challenges identified. In addition, although several reform models have been discussed, these models lack the application of scientific methodologies and modeling techniques in understanding FDA as a complex sociotechnical system. Furthermore, tools and methods to assess the efficacy of the models before implementation are largely absent. Conclusions The findings suggest the efficacy of model-based systems engineering approaches for identifying opportunities for significant improvements to the FDA review and approval process. Using this holistic approach will serve several investigative purposes: identify influential sources of variability that cause major delays, including individual, team, and organizational decision making; identify the human-system bottlenecks; identify areas of opportunity for design-driven improvements; study the effect of induced changes in the system; and assess the robustness of the structure of the FDA approval process in terms of enforcement and information symmetry.

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Section: Resultsmentioning

confidence: 99%

Section: Study Selectionmentioning

confidence: 99%

Investigating the Food and Drug Administration Biotherapeutics Review and Approval Process: Narrative Review

Olivencia¹,

Sasangohar²

2021

JMIR Form Res

View full text Add to dashboard Cite

show abstract

“…In addition, only a few studies have applied modeling approaches with direct application to pharmaceutical products and process design and analysis [13,27]. Most research efforts were industry-driven and directed toward the incorporation of modeling tools into drug development and production practices, with the purpose of enhancing the process by reducing the cost and time to market of the products [14,26].…”

Section: Models and Points Of Viewmentioning

confidence: 99%

Investigating the Food and Drug Administration Biotherapeutics Review and Approval Process: Narrative Review (Preprint)

Olivencia¹,

Sasangohar²

2019

Preprint

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BACKGROUND The development, review and approval process of therapeutic biological products in the United States presents two primary challenges: time and cost. Advancing a biotherapeutic from concept to market may take an average of twelve years with costs exceeding one billion dollars. Even after significant time and resources have been invested in a therapy, the product may still fail the U.S. Food and Drug Administration (FDA) approval process. A subset of advocacy groups and experts in drug regulations and policies are demanding a more rapid approval and release of bio-products. Despite the FDA’s practices to expedite the approval of new therapies, seeking FDA approval remains a long, costly, and risky process. OBJECTIVE The objective of this paper is to explore the factors and gaps related to the FDA review and approval process which contribute to process inefficiencies and complexities, as well as proposed methods and solutions to address such gaps. This paper aims to investigate the available modeling efforts for the FDA approval process of therapeutic biological products. METHODS A scoping review of the literature was conducted to understand the scope of published peer-reviewed knowledge about challenges, opportunities, and specific methods to address these factors and gaps related to the review and approval of new drugs, including therapeutic biological products. Relevant peer-reviewed journal articles, conference proceedings, official reports from public policy professional centers, and official reports and guidelines from the FDA were reviewed. RESULTS To the best of our knowledge, none of the articles identified in this scoping literature review have modeled the current FDA review and approval process structure to address issues related to the robustness, reliability, and efficiency of its operations from an external point of view. While several studies summarize the FDA approval process with clarity, in addition to bringing to light the problems and challenges that the regulatory agency is facing, only a few attempts to provide solutions for the problems and challenges identified. In addition, while several reform models were discussed, broadly stated, these models lack the application of scientific methodologies and modeling techniques in understanding FDA as a complex sociotechnical system. Furthermore, tools and methods to assess the models’ efficacy before implementation are largely absent. CONCLUSIONS Findings suggest the efficacy of Model-Based Systems Engineering (MBSE) approaches for identifying opportunities for significant improvements to the FDA review and approval process. Using this holistic approach will serve several investigative purposes: (1) identify influential sources of variability that cause major delays including individual, team, and organizational decision-making, (2) identify the human-system bottlenecks, (3) identify areas of opportunity for design-driven improvements, (4) study the effect of induced changes in the system, and (5) assess the robustness of the structure of the FDA approval process in terms of enforcement and information symmetry.

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“…In this respect, CFD modelling has been identified as a useful engineering tool that can assist in model-based design and process understanding for many industrial applications, particularly in the pharmaceutical industry [6]. Although this industry has conventionally relied on data-driven approaches for process optimization and risk analysis, CFD offers an alternative workflow to minimise the number of experiments required and reduce the risk of failure during scale-up [7]. Traditionally, CFD has been used at a basic level to characterize mixing and energy dissipation efficiency.…”

Section: Introductionmentioning

confidence: 99%

Computational Fluid Dynamics Study of a Pharmaceutical Full-Scale Hydrogenation Reactor

et al. 2022

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The pharmaceutical industry has been quite successful in developing new hydrogenation processes, and the chemistry of hydrogenation is currently well understood. However, it is a complex process to scale and optimize due to its high exothermicity, use of expensive catalysts and solvents, and its mass transfer requirements. Therefore, the aim of this work is to develop a CFD model to be able to describe the mass transfer, hydrodynamics, and mixing with respect to changes in rotational speed for a full-scale pharmaceutical hydrogenation reactor. In the first stage, a simple CFD model is used to predict the development of the surface vortex, and it is validated against literature data. In the second stage, the CFD model is tested on a full-scale configuration equipped with a Rushton turbine and a bottom kicker to study the formation of the surface vortex. Simulation results show the ability to predict the development of the surface vortex. These results are used to estimate the liquid height and mixing time as a function of several rotational speeds, allowing us to propose novel process correlations for this particular configuration. Although modelling the complete hydrogenation process would be challenging, this work is seen as a first step towards developing models that demonstrate the use of CFD at such large reactor scales.

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Process modeling in the biopharmaceutical industry

Cited by 5 publications

References 46 publications

Investigating the Food and Drug Administration Biotherapeutics Review and Approval Process: Narrative Review

Investigating the Food and Drug Administration Biotherapeutics Review and Approval Process: Narrative Review

Investigating the Food and Drug Administration Biotherapeutics Review and Approval Process: Narrative Review (Preprint)

Computational Fluid Dynamics Study of a Pharmaceutical Full-Scale Hydrogenation Reactor

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