INDUSTRIALIZED CONSTRUCTION IN LIFE SCIENCES

Achieving greater predictability, improved design processes, faster time to market, and reduced capital risk.

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Industrialized construction: how it impacts life sciences manufacturing

The life sciences industry needs a better way to design and build manufacturing facilities and Industrialized Construction (IC) is that better way. Industrialized Construction is generally understood to be the application of manufacturing strategies to the built environment, but it’s much more than that. IC is a holistic approach to the built environment that leverages systemization, digitalization, digital fabrication, and automation to drive continuous improvement in design, fabrication, and construction activities. IC represents a significant advancement in the way technology is changing the industry and stands to benefit the life sciences field in many ways, including greater predictability, improved design processes, faster time to market, and reduced capital risk.

Current projections indicate that the majority of buildings will be constructed using at least some aspects of IC by 2035. This shift is advantageous to the changing nature of life sciences, where industry variability and complexity are increasing at nearly the same rate as market demands and cost pressures. To benefit from this change it is imperative that the life sciences industry leverage IC solutions to connect systems, people, and data to achieve repeatability, predictability, and scalability across all capital projects. Particular emphasis must be placed on solutions that reduce time to market, improve design processes, increase predictability, and achieve greater conformance and compliance such as the IC-informed standardized facility approach outlined in the BioPhorum whitepaper, “Improving the biomanufacturing facility lifecycle using a standardized, modular design and construction approach”.

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Introduction The life sciences industry has seen rapid growth and transformation in the last decade. As a result, the heart of life sciences today rests in the progression of biological sciences. These advancements, including biologics and precision medicine, are converging with automation and artificial intelligence to address some of the world’s most complex health issues, such as food insecurity, climate change, and pandemics.

Manufacturing plays a significant role in the advancement of life sciences with the production of pharmaceuticals, medical devices, biomedical technologies, and more. Life sciences manufacturers

must meet ever-increasing quality, reliability, consistency, and regulatory requirements while managing project-related expenses and adjusting production capabilities. As industry demands change, life sciences manufacturing must keep pace and align production innovation with the innovation present in product creation. However, large- scale capital projects traditionally require years of investment and can result in facilities disconnected from the functional needs of facilities management. This creates a need for solutions that provide more insight and accountability regarding factory design construction timelines, data accessibility and optimal drug

production operations to meet industry expectations and market demand.

Unfortunately, traditional construction remains one of the least digitized and most labor-intensive industry sectors with historically low productivity and ever-increasing costs. The construction-oriented, and manufacturing-driven processes of Industrialized Construction are the key to addressing the current and future needs for the complete lifecycle of life sciences manufacturing facilities.

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Current trends in IC for life sciences IC is built on the foundation of Building Information Modeling (BIM) combined with Virtual Design and Construction (VDC) and takes a systems-based approach to integrating advanced solutions ranging from generative design to digital fabrication to off-site construction. This approach can be incorporated into life sciences manufacturing to generate more consistent, predictable, and repeatable built assets in less time and with fewer capital risks.

Systems-based approach Generative Design and the related fields of AI and machine learning are shifting the application of BIM and VDC from simply documenting digital design and construction information to solving multi-objective goals in real-time. This is based on

expressing life sciences production processes as an explicit, logical procedures and requirements in a in a format which allows computers to fully explore all permutations and rank them according to facility- specific constraints. This future state is on the horizon but life sciences manufacturing can shift to a systems-based approach now to deliver some immediate improvements that will lay the groundwork for what’s to come.

Dynamic change management One immediate improvement is the dynamic change management enabled by Industrialized Construction. The traditional system of manufacturing is failing to adapt to production requirements related to rapid shifts in modern treatment solutions. As scientists continue to innovate

treatment solutions, facilities struggle to adjust to capacity needs and keep up with the demand. To meet this demand, companies must fundamentally alter the way work is being done to embrace emerging market trends and opportunities, and IC provides a fundamentally different approach that provides real-time feedback on the viability and impact of change requests.

Digital Fabrication Among the various digital fabrication techniques Additive Manufacturing (AM), commonly known as 3D printing, may have the most to offer for life sciences. With 3D printing it is possible to go from a digital model of an object to a finished product, not just a prototype, using a wide range of materials.

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One of the inviting advantages of 3D printing is the ability to create data-driven, purpose-built, complex, and unique components at scale with minimal waste and resource investment. In addition, this technology will only increase in practicality and popularity, while also decreasing in cost and time, as new materials and printing processes are developed. This has the potential to substantially expand innovation for life sciences manufacturing and production processes, particularly in the area of single-use equipment, components, and other consumables.

Off-site construction Off-site construction is the prefabrication of building elements and sub-assemblies (modules) in a factory prior to their transport to a site for final assembly and installation. Prefabrication of large- scale building components dates as far back as the mid-1800s; however, it has yet to attain widespread adoption in the industry. Today, the use of off-site and modular construction techniques to design life sciences facilities has increased in popularity and practicality. This

approach supports growing demands by establishing the efficacy of utilizing an extensible library of configurable modules to meet time- to-market requirements through standardization and repeatability. It also enables a shorter project timeline than traditional methods as on-site weather conditions do not impact factory-based production of modules.

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Benefits of industrialized construction in life sciences manufacturing There are several benefits associated with IC achievable for the life sciences manufacturing sector. These core benefits include cost and schedule predictability, standardized design processes, faster time to market, reduced barriers to entry, greater conformance and compliance, modularized systems, deferring of capital investment in a new facility, and better supply chain engagement— none of which traditional design and construction methods would ordinarily achieve.

Predictability The life sciences industry depends on predictability

to deliver products in accordance with market dynamics that meet patient care needs and regulations. As the lack of predictability on operational readiness for production can lead to unforeseen downtime and significantly affect the quality of production and brand reputation, so does the construction and operation of your sites and facilities. Yet the construction industry has long struggled with achieving predictable results, often due to delays caused by designs not being readily buildable. IC achieves greater predictability in project cost, schedule, and operations through bounding design variations by pre-defined parameters according to standardized systems logic. More simply, the buildability of anything designed using Industrialized Construction is predictable.

Improved design process ICurrently, life sciences facilities are designed and

constructed in a purpose-built and siloed manner. Industrialized construction creates opportunities for optimization and continuous improvement in almost all phases of a capital project by utilizing a product-based approach to design and construction. The same IC characteristics that improve predictability also improve the design process by providing

real-time feedback on design variations including cost, schedule, procurement, and operational qualification. This allows for the encapsulation of fabrication and construction rules and constraints within pre-engineered products that represent the library of parts and assemblies available to designers. With productization, life sciences manufacturers can adapt to changing markets and networks faster using standardized production logic to rapidly configure their product- based facilities while continually refining design standards to optimize manufacturing output with Generative Design. The further integration of automated validation of industry, owner-mandated and localized regulatory requirements can ensure all design solutions are compliant, reducing project timeline risks and improving operations and maintenance. As implementation of these design solutions mature life sciences will benefit from additional cost and operational savings due to the economies of scale across their supply chains.

Faster time to market or clinic Delays can occur at every

project phase including design, construction, commissioning, and qualification. Traditionally, Pharma facilities can take three to five years from design to full operations, with engineering design alone

EIGHT BENEFITS Predictability

Improved design process

Faster time to market

Reduced barriers to entry

Greater conformance and compliance Deferring of capital investment in a new facility

Standardized systems

Better supply chain engagement

https://www.autodesk.com/solutions/generative-design/architecture-engineering-construction

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taking six to 12 months. Significant design revisions are common and substantially increase project cost and schedule. For new life sciences products entering the market or a clinic, such delays shorten the window of patent exclusivity and reduce the ability of the manufacturer to maximize revenue and profit, potentially resulting in millions of dollars of lost revenue.

Industrialized construction drives faster time to market or clinic through construction standardization and design configurability which embed change management within the design, engineering, and construction processes. Enabling cloud-based technologies such as BIM, common data environments (CDEs), and generative design can be integrated to produce a vast array of conformance-validated, operations- ready facilities. And the design logic captured through these practices are site agnostic, allowing for replication of the facility and related processes across a variety of locations.

Reduced barriers to entry The greater predictability, enhanced design process, and faster time to market

achievable with Industrialized Construction all contribute to the increase in capital efficiency that

will reduce the barriers to entry for smaller and resource-limited life sciences entities. As the industry embraces industrialized construction the supply chain will develop in response. We will see the creation of new product offerings that comply with explicit owner specifications, construction standards, and data requirements. This higher level of compliance and standardization will also benefit the workforce. As steady demand and a reliable pipeline of work emerge expect to see a shift in competencies emerge, from individualized single- trade contractors to a network of multi-skilled assemblers. This will, in turn, lead to improved working conditions, a stronger workforce, and a more robust supply chain, further eliminating bottlenecks that create barriers to entry in the life sciences industry.

Conformance and Compliance Iconstruction, equipment, process, and product information. Creating these well-structured data sets

allow for continuous, automated validation of conformance and compliance throughout the entire project lifecycle. Using this digital validation approach will lead to greater innovation in the design and development of life sciences facilities

and products by eliminating time spent on non-compliant solutions.

Digital validation will also encourage solution providers to adopt comprehensive, standardized protocols for site acceptance testing and operational qualification. This will prove especially beneficial for the critical cleanroom areas which will further reduce the time and effort required for final facility validation.

Deferring of capital investment in a new facility

The self-production of a commercial drug that is still in clinical trials requires significant capital investment in a new facility prior to clinical results and regulatory approval. This creates risk for manufacturers that traditionally need to commit to their capital projects well in advance. If the drug fails in clinical trials, it is difficult to recover the capital investment. If the drug gains regulatory approval, the capacity requirements at facility startup will likely change greatly from the initial calculations. The resulting facility may be oversized and, therefore, an under-utilized job site, or it may lack the capacity to meet demand. Industrialized Construction allows manufacturers to right-size the facility to meet validation, compliance, and operational needs.

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Standardized and pre- commissioned systems Using IC to establish

standardized and pre-commissioned design and construction systems sets up the Life Sciences industry to more effectively scale up and out as needed. In addition to benefits ranging from cost savings, greater operational efficiencies, and faster speed to market, they also allow for lower capital risk during the clinical trial phase. With industrialized construction’s modular design, modular construction, and standardized systems owners can not only lower their capital expenditure risk by deferring the start of

construction projects until there is a greater certainty of regulatory approval and production needs, but by creating the potential to expand or contract production capacity in accordance with market dynamics.

Greater supply chain management Finally, industrialized

construction provides a viable path to operational efficiency and market entry for small and resource-limited companies. Built on the foundations of BIM and VDC, IC enables concurrent construction of project phases. The traditional practice of serialized, non-standardized construction

precludes such work and often leads to bottlenecks and knock-on delays when a single phase falls out of sequence, upsetting production starts not only for owners but for a project’s many subcontractors as well. To enable improved supply chain management, the complexity of construction data management and on-site trade coordination is pre-defined through productized assemblies and compliance-driven configuration rules, which reduces the burden on subcontractors and overall project risk.

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Limitations of industrialized construction in life sciences IC is still in its early stages, and despite its enormous potential to provide solutions to the pressing problems experienced in life sciences manufacturing, certain limitations to its development and broader adoption currently exist. Some of the current limitations include industry cooperation, localization, long-term investment, and late-stage design changes.

Industry cooperation There are many benefits to IC, some of the greatest being the ability to establish predictability, repeatability, and consistency. While technology can help to facilitate these benefits, industry cooperation is required to activate them at scale. Specifically, there needs to be industry alignment regarding process design, interface, and operational standards. Historically, this has been one of the most challenging aspects of advancing innovation at a comprehensive level.

Localization When reviewing local regulatory requirements, there must be an understanding that a single standard cannot address all local variations. Instead of selecting individual point solutions, adopting a standard technology framework, or platform, and explicit manufacturing process logic should be developed that allows for local variability as needed. Doing so will address the need for individualization and customization based on facility-specific needs.

Investment Effectively deploying BIM, VDC, and other digital technologies for life sciences requires an additional investment on top of the capital investment needed for developing the physical facilities. To address

this limitation, the industry must create an environment of opportunity to support the development of a digital life sciences ecosystem. This ecosystem will benefit the supply chain by creating a broader and more visible pipeline of work to stimulate a digitally enabled market for products and services.

Late-stage Design Changes While IC greatly improves change management, the life sciences industry needs to move away from a culture of late-stage design changes which inherently involve risk and can threaten the high compliance, regulatory nature of life sciences production. Modifying products pre and even during production generate significant additional costs that can threaten the overall ROI of a capital investment project, regardless of its delivery method. The negative impacts of such changes increases the further into the lifecycle that they occur.

FOUR LIMITATIONS

Industry cooperation

Localization Investment Late-stage design changes

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IC in life sciences manufacturing The use of modular design and modular construction in life sciences manufacturing provides facilities with the highest level of predictability and flexibility available. This “plug and play” model enables manufacturers to defer capital costs and right-size a project until they have greater certainty of approval and a better understanding of production needs while still meeting demands and reducing time to change over.

IC’s orientation toward prefabrication and offsite construction further enhances adaptability and cost savings. Manufacturers can reduce the risk and liability associated with onsite construction activities while increasing worker safety. Fewer people present on a jobsite translates to cost savings in the form of fewer worker injuries and reduced

insurance premiums. Real-world examples are already validating these benefits.

A great example comes from a global pharmaceutical industry company that embraced modular design construction to minimize cost and delivery throughout compressed timelines. This organization set the goal of “zero incident, zero defect, zero waste” as an objective for its new facilities. In order to achieve this objective, the healthcare co- developed and deployed an IC-based system they called “Factory in a Box” with an IC-savvy architecture firm. Instead of using traditional procurement methods, this system delivers rapid, safe-site construction with building components developed using Design for Manufacture and Assembly (DfMA) principles, optimizing for both the fewest

construction elements and the simplest assembly methods. The result allows for greater control of facility design, construction, operation, and maintenance.

To better understand the processes, costs, and resources associated with IC-driven facilities, the organization had a prototype building produced to serve as a showcase for its widely publicized commitment to providing leading life sciences and healthcare resources to developing nations. The company is now looking to expand this system to provide greater levels of mass customization, flexibility, quality, and compliance at future facilities. In addition, the company now has a strong model to follow as it implements the practice in more complex, varied, and underdeveloped markets worldwide.

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Autodesk commits to life sciences Life sciences manufacturers are increasingly relying on adaptable facilities and supporting technologies to produce emerging, innovative treatments. Consistency, repeatability, extensibility, automation, and compliance are critical factors for ensuring their ability to meet changing market needs in a profitable manner. Autodesk believes that insightful data and connected workflows can help the life sciences industry achieve the benefits of industrialized construction to can get the right information to the right people at the right time. Autodesk is committed to supporting IC-enabling technologies that optimize project life cycle stages, reduce risk and waste, and drive strategic decision-making.

Autodesk supports life sciences manufacturers in their journey to unlock the benefits of industrialized construction through its product suite. This suite delivers the following:

Best-in-class design and data authoring tools that drive industry data standardization

Differentiated value and unique insights across the project lifecycle through an integration of the product portfolio

An open ecosystem that inspires cross-discipline network effects and fluent data exchange between Autodesk and third-party tools

The future of life sciences The life sciences industry is increasingly relying on innovative drug product capabilities, biosimilars, and the like to meet both cost and outcome pressures from providers and patients alike. This increased competition and downward cost pressures transfer directly to the manufacturing space. It is no longer enough to rely on traditional means of design and construction. Siloed, inaccessible data further impedes strategic decision-making around operational efficiencies and the ability to boost return on investment.

Life sciences manufacturers must differentiate themselves in the market through cost, speed, and flexibility. The use of industrialized construction, with an emphasis on modular design and modular construction increases the reliability of data-driven insights along with

greater production flexibility and lower-cost systems-based processes. As facilities and production processes are discretized into functional modules manufacturers will reap the benefits of lower capital costs, reduced operating expenses, and faster time to market. Achieving these benefits is dependent on data accessibility and reliability. Traditional manufacturing processes capture information across multiple systems that maintain compliance but reduce visibility and access. With cloud-enabled technologies like BIM and VDC, and digital-native processes like Industrialized Construction, life sciences manufacturers can access data at any time, from anywhere, while maintaining compliance. This increased accessibility leads to better decision-making and more predictable project outcomes.

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To explore how your company can benefit from Industrialized Construction visit boards.autodesk.com/lifesciences

or, contact your Autodesk representative.

Autodesk, the Autodesk logo, and Fusion 360 are registered trademarks or trademarks of Autodesk, Inc., and/ or its subsidiaries and/or affiliates in the USA and/or other countries. All other brand names, product names, or trademarks belong to their respective holders. Autodesk reserves the right to alter product and services offerings, and specifications and pricing at any time without notice, and is not responsible for typographical or graphical errors that may appear in this document. © 2021 Autodesk, Inc. All rights reserved.

What’s next for life sciences

The pace of changes and pressure to innovate in life sciences only continues to accelerate. Clinical trials are growing more efficient, and decision gate timelines are being shortened. As more products arrive in manufacturing environments with increased variations, it has become clear that current processes must also change.

Future success in the life sciences industry requires an explicit, shared understanding of the requirements needed to meet market and treatment demands. Successful approaches to the design and construction of capital projects must center around consistency, configurability, and predictability. Traditional processes that rely on years-long project phases and costly modifications do not offer the timely ability to scale production capacity or dynamically manage change throughout the project lifecycle.

The life sciences industry must move to design and construction practices that allow for automation and rapid evaluation of project requirements. Industrialized construction provides numerous ways to meet these needs while generating cost savings and increasing speed to market. Of those, modular design and modular construction increase facility design reliability and repeatability while improving cost certainty and expanding the supply chain. Additionally, manufacturers can continuously improve their output using data- driven insights that power strategic decision-making and real-time refinements at scale. The advantage of data insights will only grow as data from past projects and current operations starts to inform decisions regarding quality, costs, schedules, and operations going forward.

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