On the Hunt for a Productive New Biomanufacturing Site?

LIFE SCIENCES

On the Hunt for a Productive New Biomanufacturing Site?

Real estate and facility strategy can fuel efficiency, scale, and speed to market for your new biomanufacturing operation.

By Travis McCready, Executive Director, U.S. Life Sciences Markets, JLL

Amid explosive demand for biology-based innovation, many biomanufacturing organizations are expanding their footprints, requiring advanced real estate strategies to optimize their growth plans. With shrewd site selection, workplace design, and facility management, launching your new site can be a boon to production — while fueling efficiency and attracting prize talent over the long term. Expansion may well be urgent, considering growing pressure for warpspeed innovation and production. Today’s biologics are supporting a global patient base that’s only going to increase. Thanks Courtesy: ScieGen Pharmaceuticals to continuing breakthroughs in medicine, more people live longer lives — and seek out more therapies as they age. Meanwhile, millennials are reaching their earning potential, and many prioritize spending on personalized care.

Worldwide pharmaceutical sales are predicted to escalate at a compound annual growth rate (CAGR) of 7.4 percent through 2026, to nearly $1.4 trillion in sales, according to JLL’s 2021 Life Sciences Real Estate Outlook.1 This represents a major spike in the next six years compared with the previous six, when sales grew at just 2.9 percent. Notably, much of this growth is expected from biotechnology-driven therapeutics sales, which on their own are on pace to grow at a momentous 10.1 percent through 2026.

In addition to meeting rising demand for general bio-

logics therapies, the industry response to COVID-19 will have lasting impact, too. Urgent vaccine production is driving a reinvention of life sciences manufacturing and creating a ripple effect of accelerated production. Since the pandemic began, 600 tests, drugs, and devices were granted emergency-use authorizations, a previously seldom-used regulatory pathway, with many expected to gain Phase II approval over the next three years. Additionally, broad-based support for reshoring of manufacturing will likely increase potential speed to market and profitability into the future.

Critical Key Steps

ScieGen Pharmaceuticals’ $15.5 million expansion project in Hauppauge, N.Y., involves converting 65,000 square feet of existing warehouse space into new lab and office To keep up with all the momentum, biotech facilities. innovators need access to well-located, complianceforward, talent-friendly manufacturing facilities. Following are three critical key steps to accelerate opening — and position the location for longer-term agility and innovation. Step 1:

Foster innovation with tech-fueled site selection.

Choosing the right location is critical to efficiency, compliance, and talent considerations alike. You’ll need to weigh a range of competing criteria, including proximity to research and development (R&D) facilities, supply partners, and labor pool. For example, choosing a Good Manufacturing Practic-

es (GMP) facility near R&D operations can shorten the supply chain and allow for collaboration between researchers and manufacturing staff that will develop and refine processes, particularly for smallbatch, clinical trial manufacturing. Generally, it’s also important to look for facilities with generous, clear heights; ample utilities; and backup power; as well as easy access to major transportation infrastructure.

Yet, it’s challenging to find ready-touse biopharmaceutical production space in the U.S. — especially near the most advanced clusters in Boston and San Francisco. According to JLL research, longterm employment increases, industry and demographic shifts, record funding, tight vacancies, and rising rents are all signs of space limitations in the life sciences real estate market.

Fortunately, advanced data and analytics tools can bring accuracy and speed to your search, helping you elevate worthy location options and avoid costly missteps. By visualizing multiple sites against your criteria, you can assess the pros and cons of any location, from macroeconomic data and tax incentives, to prospective path, to ownership and flexibility.

If your initial searches aren’t promising, it may be worthwhile to consider adaptive reuse. Building a new facility in the right location is complex and timeconsuming — a mismatch for fostering innovation. Leasing and adapting an existing GMP space can help your organization expand production faster, leaving more resources for R&D.

Consider, for inspiration, the Seattle developers who are converting a former T-Mobile data center space in the crowded Bothell submarket.2 Other creative adaptive re-use stories include repurposing a former ice-skating rink, a printing press facility, vacant malls, and big-box stores.

Once you’ve narrowed down the right location, turn to a project management team to help accelerate facility buildout from design and site plan review through implementation. An experienced project manager can help navigate the entire process, from facility system decisions like electricals and HEPA filtration, to procurement and contracts, to commissioning and validating production processes.

“TODAY’S BIOLOGICS ARE SUPPORTING A GLOBAL PATIENT BASE THAT’S ONLY GOING TO INCREASE.”

Step 3:

Step 2:

Design flexible space for the people who will use it.

Biomanufacturing facilities are first and foremost a workplace. The people who work there day in and day out will perform better if they are supported by the space to do their best work.

Integrate human experience into design strategy from the outset. You might begin by providing space for employee well-being features, such as natural light, outdoor views, plants, and high-quality indoor air. Most leading life sciences organizations have already recognized these advantages in other facilities, but today’s in-demand biomanufacturing specialists are also uninspired by the windowless and cramped settings of traditional manufacturing facilities. Create flexibility in your buildout throughout, to support a quality work environment while also strengthening organizational agility. After all, research priorities can change rapidly, as can manufacturing technologies. To avert functional obsolescence, incorporate flexible design principles that allow for new configurations and foster more agile operations, like “plug-and-play” equipment, moveable workbenches, and retractable electrical coils. Other strategies include adding thick floor slabs in corridors to support movement of heavy equipment in and out without damaging the floor. Space configuration can also play a role in improving the human experience at work. As biomanufacturing becomes more collaborative, laboratory researchers, engineers, and data scientists alike will increasingly work alongside each other at intervals through the pre-clinical manufacturing process. Often this cross-section of colleagues requires a mix of collaboration-oriented workspaces that they can claim as needed.

Positioned in lower floors near entrances and exits, these collaborative areas can also help facilitate flexible working patterns while showcasing a culture of collaboration. By offering inviting, well-lit spaces with video-conferencing capabilities, whiteboards, and open seating, your organization can show it values idea exchange and multidisciplinary innovation.

Other ways to leverage workplace design to support recruitment and retention include on-site cafeterias, huddle booths, informal lounges, and other casual socialization areas — balanced by their opposites: quiet rooms and/or a library for heads-down work.

Boost productivity with leading facilities management.

Biopharmaceutical manufacturing has traditionally been resource- and cost-intensive, in part due to its low yields and relatively high level of waste. With facil-

ity management (FM) best practices, however, organizations can make significant gains in efficiency. Effective FM teams can start with the basics, solving facilities distractions and making repairs as they come up to create a reliable environment that supports core employee productivity. They can also perform mundane, yet critical, operational tasks such as providing a steady supply of clean glassware and research or testing inventory so that their teams don’t have to. But they can go further, too. With preventative maintenance practices, FM experts can avert costly replacements, extending equipment life — and long-term value.

Importantly, experienced life sciences facility managers know that manufacturing facilities for breakthrough therapies need more specialized knowledge than is needed for facilities in other manufacturing sectors. In fact, for biologics, cell and gene therapy, and other emerging biotechnology modalities, manufacturing facilities demand the same kinds of compliance, quality control, and maintenance strategies as are required in R&D environments.

To produce, test, and improve development of today’s increasingly sophisticated class of drugs, companies need access to compliant, GMP facilities. They need to know their facilities are in continual compliance with FDA regulations governing safety, sanitation, and qualitycontrol procedures from production and processing through packaging. By partnering with a trusted facilities management provider, biomanufacturing leaders can stay laser-focused on their core work, entrusting their partner with the critical matter of compliance.

Worthy FM service providers can add further value by contributing a deep bench of skilled workforce. Leading providers will have invested in talent, technologies, and best practices to manage the most challenging, highly specialized lab and manufacturing environments across the life sciences industry. They may also be able to offer substantial pricing discounts on supplies and services through their own vetted supplier networks.

If you’re considering enlisting a third-party facility management company, look for parties with a deep track record in facilitating regulatory compliance, operational consistency, and quality assurance in diverse, sophisticated facilities.

To support quality and optimize uptime, enlist select FM leaders early in the process to create standard operating procedures for safety, calibration, quality assurance, and other critical areas well before production begins — and to maintain 99 percent uptime and rigorous regulatory compliance from there on out.

An accelerated site launch is only the beginning.

In the coming months and years, biotechnology companies can expect to see more demand for their products — if they step up to the opportunity now. Breakthrough treatments will always be needed, and a growing global population guarantees demand will only continue to increase.

Whether you’re preparing to launch a site to support clinical trials, or for full-scale to-market production, providing the right facility — in the right location and with the right strategy — will help advance the global effort to improve quality of life for people around the world. n

1 https://www.us.jll.com/en/trends-and-insights/research/life-sciences-real-estate-outlook 2 https://www.jll.co.uk/content/dam/jll-com/documents/pdf/research/jll-uk-2020-uslife-sciences-real-estate-outlook.pdf

Shaping Compliance for Your New Biomanufacturing Facility – Continued from page 19

On the staffing side, fill your operations benches wisely by following best industry practices. Technical operations in a biotech plant require various highly specific skill sets and types of support. Some areas will likely be subject to more regulatory issues than others, requiring more compliance hands on deck. Other areas will need more technical engineering expertise.

But too few, or too many, people in a given role or location can be risky in its own way. Under-staffing poses operational risks, raises the potential for equipment issues, and generally drains efficiency; while over-staffing creates unnecessary cost burdens and can even diminish staff morale.

Benchmark staffing and operations against other organizations — and within your own facilities — to assess what will be too many, or too few, of the specific kinds of professionals you need on the floor and throughout the manufacturing facility.

Prioritize Facility Strategy — While Keeping Innovation Front and Center

Operational efficiency and leading compliance practices are proving more important than ever amid the burgeoning biotech boom. Increasingly, bringing breakthrough innovation to market depends on access to reliable facilities, where processes won’t be disrupted by compliance issues or operational breakdowns.

A worthy biomanufacturing facility management program enables both compliance and operational excellence, directly feeding scalability and productivity so biotech leaders can keep their focus trained on the life-enhancing work of pursuing new therapies, relentlessly. n

1 https://www.areadevelopment.com/Biotech/Q4-2021/on-_the-hunt-for-productive-newbiomanufacturing-site.shtml 2 https://www2.deloitte.com/us/en/pages/regulatory/articles/life-sciences-regulatoryoutlook.html 3 https://www.us.jll.com/en/views/four-questions-for-scaling-biotech-companies