Benefits of highly flexible biopharma facilities

Innovation and breakthrough are biopharma watchwords. But for an industry built on a foundation of constant change, there’s a clear disconnect between the mission-critical, continuous drive for something new and the inflexible facilities that house operations. Today’s biopharma facilities are built for today’s use, with little thought about tomorrow.

What’s the typical approach when there’s a process innovation or a new drug coming to market?  Start over in a brand-new building, with permanently embedded equipment designed around a specific process.

But this approach is expensive and unsustainable. New life sciences production facilities can cost anywhere from $500 million to upwards of $1 billion. They can take years to bring on line, given the extensive planning, permitting, construction, and qualifying required. With the rapid pace of discovery, innovation, and change in the industry, these buildings could be close to obsolescence from the moment the doors open.

However, retooling or reconfiguring this new facility, with its permanent equipment and structural barriers, could be too expensive, too time-consuming, and too disruptive. The result? Rather than contributing to company goals, the facility begins life by putting the company at a competitive disadvantage, making it more difficult to respond to competitive pressures, changes in demand, or technological advances that could improve operational efficiency and reduce costs.

White paper proposes alternative approach

A new white paper from the Industrial Asset Management Council (IAMC) and the Society of Industrial and Office Realtors (SIOR) proposes a way forward that upends the traditional thinking about designing biopharma facilities around a single product using today’s processes. “Rx for Change: The Flexible Biopharma Facility of the Future” outlines creative and practical suggestions on how to extend the lifecycle of future biopharmaceutical facilities so they can be reconfigured quickly, efficiently, and cost-effectively for rapid scale-up and scale-down, technological change, scientific breakthroughs, and process innovation.

In an informal, anecdotal survey conducted by the DesignFlex2030 design team, biopharma facilities users confirmed what the team had suspected: that the evolution in the biopharma value chain will impact future facilities decisions.

The industry has often responded by building separate, stand-alone facilities with permanently installed equipment to produce a single product. “When demand wanes or the outdated facility has run its course, it is shuttered,” according to the author of the white paper, Anne Moline. “So, companies are left with legacy facilities that they wind up selling for pennies on the dollar.”

Disruptive industry trends

Here are some of the top disruptive industry trends and pressures that will affect the future design of life sciences facilities, as identified by facilities users interviewed by DesignFlex2030 team:

  1. Process, equipment, and technology innovations Increased reliance on single use/disposable production shift to continuous processing, and a smaller footprint – “What we used to do in a 600,000 square foot plant we’re now doing in a 200,000 square foot plant,” says one life sciences company real estate advisor. “

Widespread use of 3D/4D printing for identical cell lines likely will replace the need for breeding colonies of live animals for research and for mammalian cell culture manufacturing— thus reducing vivarium space needs. Facilities implications of the innovation trend include: Open and flexible space; portable, easy-to-install, self-contained processing units; flooring that can support heavy loads; plug-and-play utility connection; decentralized, segregated HVAC and controls for production of multiple products and a variety of processes.

  1. New therapy discoveries, changes in drug development, fast-tracked regulatory approvals & personalized medicine – The increasing work in personalized medicine, means a shift from the large manufacturing process to small-scale lab processes. Regulatory authorities will have local outlets to fast-track new molecules, meaning a shorter time to market.

Facilities implications include: Colocation of the central lab, pilot, and production for increased collaboration; smaller footprints; smaller batch processing; agile facilities capable of rapid change-outs, integration of next-generation equipment; and production of multiple products using multiple processes.

  1. Cloud-based R&D – Early research and discovery experimentation will always require a certain amount of hands on bench work, however, as the research matures, cloud-based experimental platforms allow for high throughput parallel processing across a range of variables such as samples, acidity, and temperature. Cloud technologies enable researchers to run experiments repeatedly with the exact same parameters.

Facilities implications include: Central lab linked to CROs around the world; fewer benches; co-location of central lab with pilot and production for increased collaboration.

  1. Drive for higher throughput, lower cost and optimized utilization – The average cost from new molecule discovery to regulatory approval today tops $2.6 billion. That’s a climb from more than $1 billion in the early 2000s and up from about $179 million in the 1970s. Drug development costs are not expected to decline. Many experts also suggest that the era of the blockbuster drug is over due to the popularity of personalized medicine and custom treatments. The push for “better-faster-cheaper” will require more collaboration early on. This collaboration includes scientists, technologists, facilities staff, process engineers, and designers.

Facilities implications include: Flexibility to expand and contract quickly to meet business needs; rapid upgrades and modernization; speed to embrace technological innovation such as continuous processing and process analytical technology (PAT); shift from fixed to disposable equipment; ability to change out processes quickly, easily and with limited disruption; and collaborative spaces.

  1. Competition from biosimilars – There emerging “dogfight” between biologic and biosimilars, according to one of the professionals interviewed for the white paper. Industry insiders foresee greater pressure on cost and time to market. Simpler and more flexible facility designs will make it easier for organizations to reconfigure their infrastructure to handle the next project.

Facilities implications include: Limited use of permanently installed equipment; scalable, adaptable design; and nimble global real estate strategy to accommodate swift ramp up from pilot to full production, fill-and-finish, and global distribution.

  1. Workforce issues – It is possible that biopharma facilities of the future will require fewer people. At the same time, North American organizations are facing a shortfall in STEM talent just as the number new jobs that will require technical skills are is on the rise.

Facilities implications include: Location considerations that take into account proximity to higher education institutions and industry clusters; need for public transit and commuter options; attractive environment; green and sustainable features; and transparency and accountability.

Universal manufacturing space with minimal structural barriers

Among the many practical suggestions, the paper proposes a facility design that is essentially a shell and a wide open universal manufacturing space inside. By minimizing use of structural columns, open space is maximized for total flexibility. Pre-fabricated modules, self-supported with their own mechanical capabilities, slide in and slide out. This allows for easy manipulation of the interior to accommodate process changes and technological advances.  Individual units can work independently or combined, so internal spaces can be altered with minimal construction disruption.

Stainless steel tanks for upstream and downstream purification are anchored to skids with plug-and-play power amplification units for ease of removal and replacement within modules. Self-contained individual rooftop HVAC units enable better access for control, monitoring, and repair.

Modulization enables co-location benefits

Additional modules can house fill-and-finish units that can be co-located on site or shipped anywhere in the world, depending on market demand—and on changes in incentives and tax regimes. Other on-site modules can house pilot production of new drugs in the clinical trial stage, allowing for cross-team consultation to optimize future production processes.  Colocated lab areas—also modulized—are designed for maximum flexibility as well, enabling shared core instrumentation among other benefits.

The configuration allows for massive ramp up for a single blockbuster drug. It can produce anything from monoclonal anti-bodies to small molecule, oral solid dosing—in massive quantities or on a small scale. Manufacturing of multiple products can take place at the same time, using both continuous and batch production approaches, depending on what works best.

Focus on disposables in upstream and downstream processes

The proposed wide-open design approach supports the growing use of disposables in bioprocessing as reactors become able to accommodate larger-scale capacities—by the year 2030, it’s estimated that they could handle up to 5,000 liters of material.  Large plastic bags store and transport buffers and media in an airtight, dust-free process, connected to reactors via large volume plastic tubing that also gets discarded after use.

A ‘future-proof’ facility

Overall, this non-traditional plan enables adaptability and adjustment, allowing for new job roles, different kinds of collaboration, innovation, discovery, and advancement—yielding a “future-proof” facility.

 

J. Tate Godfrey

J. Tate Godfrey is, is executive director of Industrial Asset Management Council (IAMC). IAMC is the leading association of industrial asset management and corporate real estate executives, their suppliers, service providers and economic developers. SIOR is the leading professional office and industrial real estate association that promotes and funds programs that advance the real estate profession.

 

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