Read time: 5 minutes
The life sciences industry is marked by rapid advancements and breakthroughs. A critical yet often overlooked aspect of bringing your biotechnology to life is establishing complex laboratory spaces. However, setting up these spaces to operate reliably and efficiently is no easy task. A misstep in the facility activation could result in costly rework, delayed operations, or a missed opportunity to capitalize on speed to market.
To ensure your organization is well-equipped to meet demands, progress your life-changing technology, and advance your business, special attention should be given to regulatory compliance, space planning and commissioning.
Fulfilling Comprehensive Regulations
Biotechnology laboratories operate within a highly regulated environment, and these regulations can pose significant challenges around design, equipment and operations when onboarding new facilities. This becomes more complex when a Current Good Manufacturing Practice (cGMP) laboratory is necessary. The cGMP regulations are not merely a set of rules to follow, but a comprehensive system of extensive planning, training, documentation, and audits that assures the identity, strength, quality, and purity of drug products. A well-structured and efficient facility activation process is crucial to ensure regulatory compliance, operational readiness and speed to market.
The cGMP system integrates technologies and innovative approaches across several key facility components to achieve higher quality through continuous improvement. In 2011, the Mayo Clinic established the Center for Regenerative Biotherapeutics to provide clinical solutions for patients suffering from the lasting effects of chronic and degenerative diseases. As they developed their healing solutions, they were ready to establish facilities capable of advancing their therapies from conceptualization through development, clinical trials, and patient treatment. The first step towards realizing this vision was to build out multiple cGMP and cleanroom spaces certified up to ISO 7 (Class 10,000) in One Discovery Square to support their product development.
To prevent project setbacks or expensive rework, the project team enlisted a Food and Drug Administration (FDA) consultant to guarantee operational requirements were met for the cGMP spaces during the project’s design phase. “We weren’t just thinking about the built environment, we prioritized understanding the science being conducted,” explained Brent Webb, business development executive with Mortenson. “This ensured equipment, utilities, and systems met the regulatory requirements and factors like workflow continuity, equipment installation and documentation were all aligned to foster productive operations from day one.” As a result of their investments in laboratory spaces, the Center for Regenerative Biotherapeutics has discovered innovations and propelled advancements in their preclinical research, solidifying Mayo Clinic as a world-class leader in regenerative medicine.
The 90,000-square-foot One Discovery Square features offices, R&D space, manufacturing space, research labs, cleanrooms, and wet labs. It is the anchor of Discovery Square—one of six sub-districts making up the Destination Medical Center (DMC) in Rochester, Minnesota. Optimizing Laboratory Space
One of the primary components of the cGMP quality system is equipment selection and organization. To meet FDA standards and seamlessly transition from construction to operations, organizations must validate that equipment and materials placement and process flow will prevent contamination. But conceptualizing the flow and functionality of a two-dimensional plan can be difficult. Beyond space planning to prevent mix-ups, it is essential these high-investment facilities achieve optimal output, are easy to maintain, and provide a safe space for users. Failure to adequately organize your lab space could result in delays in research or production, product recalls or rejections, regulatory fines or penalties, safety hazards, and missed revenue opportunities.
Supporting their entry into the therapeutic DNA Oligonucleotides market, Integrated DNA Technologies (IDT) transformed a portion of a 40,000-square-foot office they owned into cGMP and protein labs. Halfway through construction of their labs, a future user of the space expressed a need to bring all their existing equipment on-site to confirm their equipment spacing and workflow. To provide a better solution, the project team offered to map their lab space in a virtual reality (VR) environment to save IDT the time and money required to transport their expensive equipment. “By utilizing VR goggles, IDT could immerse themselves in the digital space to test different layouts, move equipment, and visualize the impact on production efficiency,” says Randy Clarahan, market executive with Mortenson. “These real-time modifications identified challenges with the original layouts and allowed the facility users to reorient the equipment until it reached maximum efficiency and compliance.” IDT’s utilization of the virtual environment to improve their lab spaces emphasizes their commitment to continual improvement and further positions them to deliver the highest quality of custom oligos to their market.
A virtual reality environment was crafted to replicate one of IDT’s laboratory spaces. This immersive simulation featured movable, essential equipment. End users donned VR goggles and seamlessly interacted with the equipment, adjusting its position in real time to optimize workflow and enhance production efficiency. Early Commissioning Integration
While often the final step in a construction project, commissioning and validation of a complex lab space needs to be accounted for and strategically integrated into the schedule during design. Commissioning cGMP labs adds additional barriers to completion as the process requires meticulous documentation and reviews by several entities. If the milestones and approaches to closing out these spaces are not identified and built into the schedule from day one, the team could miss an opportunity to bring efficiency to the completion process. This could result in project delays and affect the products’ speed to market.
A confidential global biotechnology developer and manufacturer in Wisconsin needed to double their existing manufacturing capacity to meet their growing needs. The process development and cGMP laboratory expansion would help produce their cellular technologies which aid in research and development for drug discovery, drug efficacy, and pharmacology.
Early in design, the project team worked with the life sciences leader to identify commissioning strategies for critical lab activities. They were intentional about understanding both major and minor activities, recognizing the significant impact efforts of all sizes can make on a project’s success; even something as “minor” as the lab’s paint. Documentation on the thickness of the wall paint applied within the lab was identified and incorporated into the construction inspection process to avoid unnecessary delays in the validation phase. “Critical points like this can derail the project's progress, if not accounted for early on,” explained Danny O’Brien, project executive with Mortenson. “It’s imperative to restructure your schedule to optimize the lab’s commissioning activities to ensure timely operations and revenue generation.” Bringing the biotechnology leader’s new cGMP space online will expand their development and manufacturing capabilities to meet increasing global market demand.
Integrating commissioning and validation early in the design process is essential for efficient lab completion. Failure to identify milestones and incorporate them from the outset can lead to delays and impact product launch timelines.
Foundations for Success
Navigating the activation process for complex life science laboratory spaces is no small feat. As organizations strive to push the boundaries of what’s possible in healthcare and research, they must pay special attention to regulatory compliance, meticulous space planning, and commissioning. These critical factors lay the foundation for success, ensuring seamless operations, safety, and efficiency within these specialized environments. By addressing these challenges head-on, organizations can position themselves for growth, innovation, and impactful contributions to scientific advancements.
See more life science facilities