Modular Design And Construction Of Biopharmaceutical Plants: Key Considerations

As the pharmaceutical market expands to new formats, manufacturers must manage multiple complex product pipelines faster than ever. But higher demand is straining capacity at biopharma companies. Therefore, innovative solutions are required to deliver and operate agile, flexible and integrated factories to seamlessly support new models from development to commercialization.

For greenfield plants using traditional methods, the timeline for a biopharmaceutical manufacturing plant from project initiation to completion of certification is typically 3 to 5 years.

Modular construction can reduce construction periods by 20%–50% and significantly reduce costs, but it requires a matching design philosophy. This design philosophy is actually a key enabler of the modular approach and subsequent standardization, with benefits not only in the design phase but also in the fabrication, construction, qualification and operation steps. It supports all construction methods, enabling biopharmaceutical companies to choose the method suitable for a specific location and region.

“Modularity” can mean different things to different individuals in the industry, depending on their background, expertise and perspective. In terms of plant design, the term “modular design block” is used for “pre-engineered” or “pre-engineered” solutions. This approach demonstrates that new plant designs need not be unique, but can use and leverage a set of pre-designed components. The further downstream the supply chain for standardized modules and components, the wider the benefits for the industry as a whole.

Can this approach be applied in the context of rapid development of new formats for biologics? Is a modular approach suitable where the production process is less mature and the schema is essentially more products? The answer is yes.

The strategic imperative for the new model of biopharmaceutical manufacturing is to deliver products through late-stage clinical development and quickly build up capacity to meet demand once a product is approved. This means that the initial plant will be followed by more plants, either of the same process size or a larger process size. Biopharmaceutical process equipment is highly modular, with very similar footprints in terms of space, utilities and operability. This applies to the modular approach regardless of the manufacturer. Modules can be pre-engineered at multiple levels, from work cells for individual process steps to entire buildings.

Part 1 How To Apply Modular Design?

Modular design uses a different sequencing than traditional design methods and has similarities to agile project planning vs. waterfall planning. There are three main steps: scoping and flow, shaping blocks, layout and testing.

Having pre-designed and grid-assembled modules does not preclude any of the three construction methods of traditional stick, modular hybrid or fully modular (box-in-box). However, repeatable design elements drive standardization of parts, a natural fit for modular manufacturing. This provides the ability to manufacture and test most of the plant’s constructs off-site, while providing biopharmaceutical companies and construction teams the flexibility to choose a hybrid approach based on local conditions and preferences.

Part 2 Modular Design And Capacity: Product Portfolio Management Strategies

Modular design helps address the challenges faced by biomanufacturers by accelerating capacity ramp-up, and it also creates an opportunity to significantly improve product portfolio management strategies. This is especially important in the current market, as companies have seen increased competition, products with lower patient populations, and product portfolios with multiple treatment types.

One thing the industry knows for sure is that they need to be able to respond flexibly to changes in demand. Strategic realignment, addition or repurposing of modular capacity enables quick response to change. Looking at the single product example, the answer to demand forecast volatility is to apply modular logic to the portfolio’s forecasted aggregate demand curve.

Part 3 Digital Enablers: Linking Modular Design And Modular Construction

Modular design must be tightly integrated with modular construction, ‘linking’ the various stakeholders into a strong value chain, offering plant owners maximum flexibility while standardizing means and methods. Digitization of products and processes is highlighted as a key enabler for taking construction to the next level.

One hurdle is the availability of consistent data that is well structured and available to all project stakeholders throughout the project lifecycle. The recent rapid acceleration of companies’ digital transformation has created opportunities to leverage how technology can connect and accelerate modular design and modular construction.

Building Information Modeling (BIM) has become mainstream for many companies in architecture, engineering, and construction, but many still don’t use it on all projects. As a result, many owners, designers, contractors, and plant managers lack insight into the design and construction decisions made by project stakeholders.

Current industry pressures create a strong strategic advantage for those companies that can initiate projects before process specifications are finalized, accommodate design and requirements changes throughout project delivery, and more. BIM and related digital enablers are about creating dynamic, data-driven digital transformations represented by connected workflows for modular design and construction.

The benefits of achieving this level of digital transformation include outcome-based design decisions supported by dynamic “what-if” options for future factory expansion and contraction. Furthermore, since BIM and related digitalization enablers are based on logical relationships between modules and blocks rather than pre-determined solutions, the modular framework remains site-agnostic, allowing standard plant designs to be localized across different locations and jurisdictions. change.

Aligning the biopharmaceutical industry around a modular plant design and construction framework will allow for rapid and agile responses to dynamic technical and regulatory environments. Additionally, facilitating the creation, maintenance and use of modular design libraries – by all project stakeholders at all scales and levels of standardization – enables substantial reuse of plant elements between projects and ensures greater cost certainty and faster execution schedule.

Part 4 Summary

By adopting a modular design approach to a biopharmaceutical manufacturing plant, design solutions can be quickly iterated and evaluated for multiple relevant scenarios to aid decision making and accelerate project justification and initiation.

After the rapid design phase, repeatability leads to additional speed and cost advantages through procurement, off-site manufacturing and factory acceptance testing, simplified on-site assembly and assembly, and qualification and operation. This can take months or even years out of facility timelines and reduces schedule, cost and regulatory approval risk. This can culminate in a phased investment approach with significant benefits for financial and business risk mitigation.