The Importance of Innovation in Facility Design for the Life Sciences
Novel therapies are revolutionizing the treatment of diseases such as cancer, neurological disorders, and other previously untreatable conditions. These therapeutics will continue to shape the future of the life sciences industry and many innovator companies are building manufacturing capacity at an accelerated pace to accommodate newly approved therapies. Research and production of new biologics are often funded by private investors, government entities or venture capitalists who expect results quickly. Companies leading the way in advanced therapeutics have trusted the DPS team to design, construct, and validate their new facilities.
I’ve seen so many changes in just the last five years, even down to the equipment used for new therapies such as mRNA, viral vectors, and CAR-T cell therapies. The curative nature of these therapies is life altering for patients; however, manufacturing space is in short supply due to the specialized nature of these products. In order to provide these treatments to patients, we need innovation in facility design. Many novel therapies have received Priority or Breakthrough Therapy designation from the FDA or other regulatory agencies, which results in these products moving from clinic to commercial at an accelerated pace. Often, we are designing and constructing facilities while the process development is still in progress. Having an engineering partner that is experienced in novel therapy facility design, construction, and Commissioning, Qualification, and Validation (CQV) is crucial for success.
These therapeutics are in high demand, and in the case of curative therapies such as cell and gene therapies, the first to approval often captures the market. It is crucial to reduce the time to market from the moment a project is conceived. By engaging early with an experienced engineering and design firm, you can improve schedule and deliver more cost-efficient solutions.
We apply Quality Risk Management (QRM) to novel drug therapy projects to reduce schedule and cost. Key players enter the project lifecycle early to set up the planning and processes needed to see all parts of the project at once, helping to identify areas for schedule acceleration. Planning early helps prevent unnecessary delays throughout the design, construction, and CQV process. Fully understanding the client’s complex needs in advance assists in designing and constructing new, novel drug therapy manufacturing facilities. Such detailed planning is especially critical for novel therapies that incorporate recombinant molecular biologics that could affect patient and/or operator safety if appropriate biosafety, containment, and segregation practices are not in place.
From a design perspective, greenfield and brownfield facilities require similar planning efforts. When retrofitting, existing materials must be removed to enable the creation of cleanroom environments either through stick-built construction, the use of modular cleanroom wall panels, or pre-fabricated cleanroom construction. Likewise, site preparation and permitting should not be underestimated when developing a greenfield site.
DPS has worked with several novel therapy clients on retrofits to bring new technology into an existing space. Our experience leads us to ask the right questions early on to ensure that details affecting schedule and budget are not missed. We recently retrofitted an existing space for production of viral vectors, increasing the facility’s biosafety level (BSL) requirements. Proper design requirements were implemented to avoid the release of viral vectors that can harm both operators and the environment. Although the client had proposed a design with a single airlock, we recognized that a double airlock would provide enhanced containment and worked to accommodate the design changes without impacting the overall square footage and schedule. Our design team leveraged their expertise to incorporate appropriately designed HVAC systems and containment strategies to ensure a successful outcome.
When we design a new facility, or retrofit a current space, we also consider future flexibility for expansion by evaluating how systems can be phased to allow for future product portfolios and requirements. All disciplines must work together to plan for future expansions including architectural, structural, process, plumbing, mechanical, electrical, and fire prevention.
Our SMEs in architecture, design, and engineering work together holistically to design, construct, and deliver the best ergonomics, style, and efficiency possible. Our goal is for your team to feel comfortable in their workspace. If a process is efficient and works well, employees will better enjoy their work environment. We employ tools include discrete event simulation to test fit layouts and ensure efficient workflows and optimize movement of material, personnel, and waste.
We value transparency and communication; we flag any concerns with a given space early to enable our clients to pivot and arrive at a solution which enables a successful project delivery. Of course, we don’t do it alone. We partner with reliable and trusted equipment vendors and recommend only what is best for your needs.
DPS truly understands the challenges you face manufacturing advanced therapeutics. From expertly designed facilities and regulatory knowledge to constructing a new facility or redesigning an existing space for new therapies, we put your needs first so that you can produce cutting-edge therapies on time and on budget. Our goal is to help you deliver life-changing therapies to your patients.
