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Shaping Compliance for Your New Biomanufacturing Facility

If you have a new biomanufacturing site in the works, you can open doors to a productive, compliance-forward facility with these strategies.

Q4 2021
Extreme demand…vigorous reshoring…unprecedented funding…the biotech boom is upon us — and inspiring industry leaders to ask how real estate can help scale up productivity and innovation. Now the hunt is on for new sites where compliance and operational practices won’t just avert disruption — they’ll actively fuel speed to market, too.

Pressure is mounting to expand production capacity, but this is not a sector where any quality industrial space will cut it. In the highly regulated biologics arena, shrewd biomanufacturing site selection is critical to short- and long-term success.

As JLL’s Travis McCready notes in his recent Area Development article, compliance and operations play a vital part in accelerating an effective site launch. To reduce risk and extract the most value possible from a biomanufacturing facility, companies need to be able to anticipate and address regulatory and technical operational challenges from the get-go.

Following is a closer examination of why compliance and operations considerations need a front seat in planning — and opening — an agile, resilient biomanufacturing facility.

How to Fuel Biomanufacturing Facility Compliance
A hair-raising two thirds of drug shortages are triggered by manufacturing disruptions related to product or facility quality problems. But rigorously informed quality and safety standards help alleviate the kinds of missteps that lead to compliance issues — and their cascading disruptions and cost impacts.

With life sciences enforcement on the rise across the board, biotech companies must ensure prospective facilities will be managed in compliance with constantly evolving FDA regulations governing safety, sanitation, and quality-control procedures.

To proceed, consider the following best compliance-related practices for all biomanufacturing facilities — new and old alike:
  1. Proactively monitor and anticipate regulatory inspection and enforcement priorities. Requirements and enforcement trends are perpetually changing, as the FDA and other authorities raise new issues and uncover enhanced compliance practices. Case in point: the FDA’s closer focus on pest control in recent years led directly to updated requirements and additional enforcement activity. Prepare for inspections and avert unexpected enforcement attention by staying abreast of evolving regulatory trends.
  2. Requirements and enforcement trends are perpetually changing, as the FDA and other authorities raise new issues and uncover enhanced compliance practices.
  3. Increase visibility around compliance and enforcement which could impact facilities. Too often, facilities compliance knowledge and experience is siloed, with disparate parties responsible for compliance, facility engineering, manufacturing, and quality. A more collaborative approach will help your organization efficiently share news and insights to improve facilities quality across the entire system. For example, if you establish a central facilities compliance team, they can easily exchange information and innovation happening at one site to others.
  4. Coordinate efforts to vet facilities vendors for regulatory compliance. It’s not uncommon for a facilities team to choose a janitorial, pest control, calibration, or other project vendor before the compliance team has a chance to determine whether their qualifications meet good practice (GxP) standards. One way forward: Give facilities teams access to a centralized platform for vendor compliance checks.
  5. Ensure compliance documentation stays up to date and meets changing regulatory standards. GxP data must meet numerous rules regarding backup, security, accuracy, documentation, and other elements of recordkeeping. Simply storing data in the wrong format can result in noncompliance. If your compliance documentation practices aren’t up to par in other facilities, now may be the time to upgrade validated technology and centralize record-keeping for new and existing facilities alike.
  6. Verify facilities operations achieve the International Standards Organization’s IS0 9001, ISO 14001, and ISO 45001 certifications. Maintaining appropriate ISO certifications can help ensure operations support your organization’s quality, safety, and sustainability goals, while also helping curb costs and foster consumer confidence.
  7. Create a culture of compliance across facilities teams. The most effective biomanufacturing facilities teams bring a compliance mindset to work each day. To cultivate a compliance culture across your organization, consider forming global quality and compliance teams, and investing in sophisticated facility technology and compliance metrics to support consistency across all GxP facilities.
Foster Operational Scalability and Agility by Design
In addition to compliance, the operational strategies you enable during construction or buildout will affect the facility’s ability to run efficiently once online. If you’re planning to open or adapt a new site, an important early step is to anticipate any and all operational details.

The most effective biomanufacturing facilities teams bring a compliance mindset to work each day. For instance, by calculating how much power and water the facility will need over time, and proactively locating utility connections, you can ensure buildout has the resources and access points it needs to fulfill current and future production orders.

Infrastructure design also has a major impact on performance and costs. Too large a boiler, for example, may cost you more in terms of additional staff required by law to operate, wasted energy, dollars, and space — whereas one that’s too small will end up costing more to maintain or upgrade, with precious time lost. Anticipate properly and you’ll get just-right solutions. And do sweat the small stuff. A seemingly simple decision, like positioning a piece of heavy equipment adjacent to electrical switch gear, could create outsized problems down the road by inadvertently limiting the ability to expand as production needs increase.

Every operational model should also purposefully foster agility. Research priorities can and will shift quickly, as do lab and production technologies. Scaling biotech companies need manufacturing facilities that can scale and be adapted for change as needed — while maintaining cost control. Operational models should allow for seamless reconfiguring between changing production schemes, so that facilities have the protocol and equipment they need to efficiently turnover labs and rapidly configure multiple types of setups.

Be sure to build in operational resiliency as well. The COVID-19 pandemic helped shine a light on the need for preparedness for a range of disruptions. Whether it’s a future pandemic, hurricane, or wildfire, facility operations should be prepared for any possible disaster. A strong business continuity plan will help restore operations and mitigate the impact of an external event on manufacturing operations.

Power Up Facilities With the Right People and Technology
Biotech facilities require more sophisticated management expertise than manufacturing facilities in other sectors. But by investing in state-of-the-art operational technology and expertise, you can optimize facilities operating costs to allocate more spend to research and development — while maintaining highly productive production environments.

On the facility tech side, this might entail leveraging digital technologies to monitor facility performance, avert equipment failure, decrease energy waste, and streamline the time-intensive facility compliance process. Speaking of time management, advanced technology can also help facility teams automate work-order management, detect burned-out lightbulbs via sensor, and handily manage inventory and vendors across multiple properties at the same time.

Bringing breakthrough innovation to market depends on access to reliable facilities, where processes won’t be disrupted by compliance issues or operational breakdowns. 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.

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