Global Regulatory Landscape

Matsuda, Yoshihiro

doi:10.1208/s12249-018-1230-x

Cited by 8 publications

(3 citation statements)

References 10 publications

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“…Matsuda has summarised the global regulatory landscape as it relates to CM and includes a table comparing the specialised CM teams, their purpose, how to contact them and what activities they have underway to support CM [ 26 ].…”

Section: Regulatory Aspects Of CMmentioning

confidence: 99%

Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms

Wahlich¹

2021

Pharmaceutics

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Continuous manufacturing (CM) is defined as a process in which the input material(s) are continuously fed into and transformed, and the processed output materials are continuously removed from the system. CM can be considered as matching the FDA’s so-called ‘Desired State’ of pharmaceutical manufacturing in the twenty-first century as discussed in their 2004 publication on ‘Innovation and Continuous Improvement in Pharmaceutical Manufacturing’. Yet, focused attention on CM did not really start until 2014, and the first product manufactured by CM was only approved in 2015. This review describes some of the benefits and challenges of introducing a CM process with a particular focus on small molecule solid oral dosage forms. The review is a useful introduction for individuals wishing to learn more about CM.

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Section: Regulatory Aspects Of CMmentioning

confidence: 99%

Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms

Wahlich¹

2021

Pharmaceutics

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“…The ability to tailor the API physical properties has the potential to add a layer of robustness to drug product manufacturing processes. This benefits both conventional batch and advanced continuous manufacturing approaches, the latter of which is an emerging technology priority recognized and promoted by regulatory agencies, − and has driven industrial, academic, and regulatory research investments …”

Section: Introductionmentioning

confidence: 99%

Recent Advances in Co-processed APIs and Proposals for Enabling Commercialization of These Transformative Technologies

et al. 2020

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Optimized physical properties (e.g., bulk, surface/interfacial, and mechanical properties) of active pharmaceutical ingredients (APIs) are key to the successful integration of drug substance and drug product manufacturing, robust drug product manufacturing operations, and ultimately to attaining consistent drug product critical quality attributes. However, an appreciable number of APIs have physical properties that cannot be managed via routes such as form selection, adjustments to the crystallization process parameters, or milling. Approaches to control physical properties in innovative ways offer the possibility of providing additional and unique opportunities to control API physical properties for both batch and continuous drug product manufacturing, ultimately resulting in simplified and more robust pharmaceutical manufacturing processes. Specifically, diverse opportunities to significantly enhance API physical properties are created if allowances are made for generating co-processed APIs by introducing nonactive components (e.g., excipients, additives, carriers) during drug substance manufacturing. The addition of a nonactive coformer during drug substance manufacturing is currently an accepted approach for cocrystals, and it would be beneficial if a similar allowance could be made for other nonactive components with the ability to modify the physical properties of the API. In many cases, co-processed APIs could enable continuous direct compression for small molecules, and longer term, this approach could be leveraged to simplify continuous end-to-end drug substance to drug product manufacturing processes for both small and large molecules. As with any novel technology, the regulatory expectations for co-processed APIs are not yet clearly defined, and this creates challenges for commercial implementation of these technologies by the pharmaceutical industry. The intent of this paper is to highlight the opportunities and growing interest in realizing the benefits of co-processed APIs, exemplified by a body of academic research and industrial examples. This work will highlight reasons why co-processed APIs would best be considered as drug substances from a regulatory perspective and emphasize the areas where regulatory strategies need to be established to allow for commercialization of innovative approaches in this area.

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“…The potential benefits of continuous manufacturing are ease of scale-up, flexibility in demand change, and the capability of reducing the number of operators [5]. Ongoing discussions on the regulatory aspects such as control strategy [6,7] are consolidating the way to implement this new technology, which promises to make some of the units or even the entire process continuous [8]. However, the progress in continuous manufacturing requires coping with the increased complexity in the process design.…”

Section: Introductionmentioning

confidence: 99%

Superstructure-based process synthesis and economic assessment under uncertainty for solid drug product manufacturing

et al. 2020

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This paper presents a new method for process synthesis and economic assessment for solid drug product manufacturing, considering continuous manufacturing as a prominent process alternative. Of the three phases of drug development, phase II was targeted where the dosage form, formulation, and processing technology are determined. For a comprehensive alternative generation, a superstructure was developed that covered 9452 options for the unit level, which was combined with two options on the formulation strategy. The generated alternative was assessed by a net present value calculation model, which was adapted for dynamic cash flow consideration in the drug lifecycle. The model can incorporate uncertainty in the drug development and manufacturing in the result, and can perform global sensitivity analysis by Monte Carlo simulation. The method was demonstrated in a case study where two different scenarios regarding the price of the active pharmaceutical ingredient and the demand for the product were assumed. The results showed that when the demand and price are both low, the labor-related costs are dominant, and in the opposite case, the material-related costs become relevant. We also introduce the prototype version of the software "SoliDecision," by which the presented method was implemented for industrial application.

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Global Regulatory Landscape

Cited by 8 publications

References 10 publications

Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms

Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms

Recent Advances in Co-processed APIs and Proposals for Enabling Commercialization of These Transformative Technologies

Superstructure-based process synthesis and economic assessment under uncertainty for solid drug product manufacturing

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