Agile and Responsive Modular Design in Biopharmaceutical Manufacturing

As a recent BioPhorum report on modular design in biopharmaceutical manufacturing points out, one of the drawbacks of establishing a new production facility—particularly for a brand new product — is the time it takes to go from design to operation. Typically, that’s a period measured in years, rather than months. It’s also a costly exercise; the longer it takes to start production, the longer it takes to bring a product to market. And that can hit an organisation right where it hurts.

Because of this, the report says, there’s now a growing movement towards modular design and construction, a process in which a facility is built from pre-fabricated, repeatable modules that are then transported to a site and assembled. Compared to a customised design, repeatable modules are cheaper to build and offer significant potential for flexibility in both the final layout—to meet specific site footprints — and also any future need for expansion. With modular construction, additional capacity can be added or repurposed rapidly — and that’s an important consideration, for the size of any plant is usually determined by the level of forecast demand. If that is undercooked, the facility will quickly reach capacity.

BioPhorm highlights the importance of standardisation in any modular design. Just as it’s critical for an organisation to limit the number of customisations made to an ERP system when implementing it across the entire business, so it’s important to standardise key design elements to ensure they are repeatable; for that’s where the cost and time savings lie.

But the key component in any modular construction is data. BIM has revolutionised the way architecture, engineering and construction companies work, but it can only deliver benefits across the entire value chain if data held in the models is accurate and accessible. For a project to proceed through to completion with as few hiccups as possible, it is essential to give project managers in the field access to BIM data so they can make informed, rather than gut decisions. Decisions taken in isolation cause conflicts and delays, which could ultimately place the entire project at risk.

Poorly managed data can also lead to delays and additional costs throughout the process, so it’s important the data is well-structured and can be used by workers throughout the construction lifecycle. The report mentions how, by federating data into Common Data Environments (CDE), a business can ensure that accurate information and the most up-to-date versions of plans can be accessed immediately, from anywhere.

The benefits of getting the digital component of modular design right are both simple and attainable. Using digital design from the outset and ensuring the data remains available to the operations team once production has commenced, enables an organisation to plan for scenarios that require strategic flexing, repurposing and expansion. In addition, producing a design around a modular approach allows for greater standardisation and therefore reduced cost. For example, if equipment or buildings are designed specifically for a certain location, the whole process needs to be repeated if the business requires another production facility. If the design revolves around modules, they can simply be repurposed for use in any location.

One of the biggest benefits of combining digital construction and modular design is that project owners can easily gain insight into the impact potential changes to the design or requirements will have on the project cost and schedule and, perhaps more importantly, on the overall value chain.

Establishing a modular facility design and construction framework means the organisation will retain the agility it needs to respond to changes in technology, regulations and sudden changes in demand—it’s not so long ago that the biopharmaceutical industry had to deal with the demand for new vaccines to counter an unexpected global pandemic. With a digitised, modular approach, an event like this would still cause plenty of headaches, but the solutions would be far easier to come by and far cheaper to implement.

For more details on the BioPhorum report entitled “Accelerating multi-product biopharmaceutical manufacturing facility project lifecycle through modular design”, download the report now.

Josh Lobel

Business Development Executive, Autodesk