modular and mobile

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Using modular construction to reduce time to market and lower costs 

It can typically take three to five years using traditional methods for a greenfield biopharmaceutical production facility to move from project inception to the completion of qualification. Being able to move faster would reduce time to market and improve business cases by reducing the time from financial outlay to income generation. As the biopharmaceutical market expands into new modalities, manufacturers must move faster than ever to manage...

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Accelerating multi-product biopharmaceutical manufacturing facility project lifecycle through modular design

This paper uses a standardized, modular design and construction approach the benefits of a modular design approach to a multi-product viral vector (VV) facility at late-clinical/early-commercial scale, showing how significant speed benefits can be gained at each stage of facility design, procurement, construction, qualification and operation.

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Modular and mobile: Improving the biomanufacturing facility lifecycle using a standardized, modular design and construction approach

Traditionally, biopharmaceutical facilities can take up to three to five years from design through qualification before they are ready for full operation. Such facilities are often product dedicated, requiring significant and costly modification to accommodate additional products once the original product lifecycle has ended. This inherent inflexibility has become a major concern for the industry, especially given the increasing pressure to reduce costs and quicken the speed to market. To address these concerns this paper proposes a standardized design approach around an example facility solution for 2,000L-scale mAb application. The example facility focuses on demonstrating how a modular design approach may be realized using various construction methods – including traditional stick-built, prefabricated and skid assemblies, as well as modular cleanrooms or complete modular building units – without requiring major reconfiguration. At the core of this investigation is the intent to align the biopharmaceutical industry around a common understanding and approach to the design and construction of manufacturing facilities that makes the capital project process more predictable by, reducing schedule durations, improving project cost certainty, increasing facility design repeatability and ensuring greater regulatory compliance.

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Biomanufacturing technology roadmap: 1. Executive summary

Current trends in the biopharmaceutical industry, continued market growth, new product groups, cost pressures and the trend towards localized manufacturing exert unprecedented pressure on biomanufacturers to innovate biomanufacturing platforms. To accelerate the industry’s journey, a technology roadmapping process has been established to determine common biomanufacturer needs and to share them openly with supply partners, academics, regulators and government agencies so that directions can be aligned and collaboration enabled. The first edition biomanufacturing technology roadmap, published in 2017 is an initial step, setting a broad vision for the future of biomanufacturing and designed to catalyze industry action. This executive summary brings together the conclusion and recommendations of each part of the roadmap, overview, process technologies, automated facility, modular and mobile, in-line monitoring and real-time release, knowledge management, supply partner management and details the overarching next steps for the industry and this collaboration.

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Biomanufacturing technology roadmap: 5. Modular and mobile

This chapter of the first edition biomanufacturing technology roadmap published in 2017, describes the vision, scope and benefits that could be gained in the biopharmaceutical manufacturing industry from the development and use of a modular and mobile approach to facility design and creating. To help the industry achieve this future state it describes the scenarios considered, the future needs, challenges and potential solutions as well as the linkages and dependencies on other parts of the roadmap. It considers the contribution that disruptive and emerging technologies can play and regulatory considerations before finalizing with conclusions and recommendations.

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