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 multiple, complex product pipelines – while handling the extraordinary demand that often strains their ability to provide capacity. As these unprecedented trends converge, innovative solutions are needed to accelerate the delivery and operation of flexible facilities that seamlessly support these modalities throughout their lifecycles. Modular design applies to all these modalities and is supremely suited to the scenario modeling and decision-making needed at the early stages of facility investment planning.
Using modular construction has been seen as a way to cut schedule by 20-50% and lower costs. But it requires a design philosophy to match. The modular design approach is a key enabler that drives the ability to take maximum advantage of modular construction and other standardizations that naturally follow.
But can this approach be applied to the fast-moving environment of new modalities in biologics? And does a modular approach work where manufacturing processes are less mature, and the modalities are inherently more multi-product?
BioPhorum thinks the answer is ‘Yes’ and has published Accelerating multi-product biopharmaceutical manufacturing facility project lifecycle through modular design.
It gives you an overview of the key concepts of modular design and contains a detailed worked example of the methodology applied to a multi-product, late-stage, clinical/early commercial viral vector facility. This shows how you can design a facility by looking at the required activities, and then identifying the repeatable elements that can be sized and designed as individual modules, before being combined into a full facility design.
A natural flow of benefits
Other benefits around risk reduction and cost efficiencies naturally flow from this approach, which increase further as modular elements are repeated in future facilities. To help you build the business case for using a modular approach, the paper also summarizes the relative benefits of an initial modular design treatment for a facility, and the benefits of working from a library of existing design blocks.
Aligning industry around a modular facility design and construction framework will facilitate a quick, agile response to a dynamic technology and regulatory space. Also, promoting the creation, maintenance, and use of libraries for modular designs at all scales and levels of standardization enables the significant reuse of facility elements across projects and ensures greater cost certainty and more rapid execution timelines.
Modular capacity to manage uncertainty
Taking the concept one stage further to modularize capacity is something that this approach can be applied to. With significant benefits to capital planning and shorter lead times between decision and operation for capacity blocks, there is more agility in the supply response to unpredictable product and portfolio demands.
The paper follows BioPhorum’s Modular and mobile: Improving the biomanufacturing facility lifecycle using a standardized, modular design and construction approach, where the benefits of a modular design approach were outlined using the example of a commercial-scale monoclonal antibody facility.