Ensuring that patients receive novel medicines is a key driver for working to reduce the time it takes to design and build a new biopharmaceutical facility.
Despite the complexity of biopharma projects, CRB’s integrated ONEsolution delivery enables fast-track design and construction, reducing project timelines by four to six months.
Seamless Effort in Less Time
When fast-tracking complex projects, design and construction proceeds in parallel. With the traditional design–bid–build approach, going from project initiation to completion typically takes approximately 20–30 months. Fast-track projects are generally executed in 16–24 months because the entire process is streamlined.
In a fast-track project, early packages are issued in order to start construction prior to the completion of the full design. For instance, the design package for the foundation and all underground components of the facility are completed first so that work on those aspects can commence while the more complex production process and interior design can be completed. While construction proceeds on the first design package, the architectural package for everything above the floor is developed, taking the needs and concerns of numerous stakeholders into account. When the next package is sent out to bid and construction proceeds, the design team readies the next package, including details regarding the location of power sources, gases and other utilities, the transportation of raw materials — and many other factors — which are established in a final design package that is approved and then sent out for bid. By performing design and construction activities concurrently during the project, timelines can be reduced by as much as 40%.
Design and Construction Staffing
Too often in the design and construction industry, firms are given unreasonable demands in an effort to achieve lean operations. Pressures are applied to keep design and construction staffing to a minimum. Because the labor cost of a design and construction management team makes up a very small portion of the overall project costs but has a great effect on the overall success or failure of the project, this is no place to skimp. CRB understands how important it is to have the right number and types of professionals on site at all times. With too few people, long hours are required, mistakes can be made and quality can decline. Equally as important, safety can become an issue. When people are overworked and the project is understaffed, injuries can occur.
Appropriate Outlook Needed
For the fast-track approach to be effective in design–build projects, clients must know what they want and have the willingness to share their experience and be involved in the project. They also need to be sufficiently flexible to allow for the development of facility designs in stages.
Foundation of Trust
The fast-track approach is appropriate for forward-thinking companies that have established trust with their design–build partner, either through previous relationships or on the basis of recommendations and the company’s reputation and track record of success. Clients must trust that their design and construction partner is honest and forthright when it comes to the dollars and cents of the project. A good design–build partner will always be transparent. Clients must also trust that the firm has the ability to do what it claims it can achieve for fast-track to be successful. In addition to facilitating fast-track processes, this type of trusting relationship invariably leads to the construction of facilities that best meet client needs because relationships are established across the board — from the owner to the architect, the engineers and the construction workers.
Increased Need for Collaboration
Indeed, fast-track projects cannot succeed without extensive collaboration between the design and construction teams within the engineering procurement and construction (EPC) firm and between the EPC firm and the client. However, the traditional design–bid–build process often creates adversarial relationships among the main players on a project. For example, in the traditional method, the architect provides complete construction documents, but when contractors later find errors or omissions in the design, they ask the owner to pay for these additional costs, which may put them at odds with the designer. Both the contractors and architect want to maximize their profitability while the owner wants to limit spending; the system inherently sets these parties at odds.
The fast-track approach, however, can only effectively be implemented by an integrated design, engineering and construction firm. With a truly integrated EPC, the architects, engineers and construction teams are accustomed to working together day after day. This familiarity breeds better, faster and more consistent results. All of the players are part of the same organization and work to support each other in order to achieve the best outcomes for the client without the added cost of rework and redesign.
To provide the best possible outcome for a given project, it is important for the owner and EPC to have similar company cultures. If both firms share the ideals of “people first” or “technical excellence,” the opportunity for a cohesive team is greater. In addition, the owner and the design-build firm must be in alignment with the project’s subcontractors. CRB, for instance, has a responsive, collaboration-focused culture and specifically selects business partners with a similar culture.
All fast-track projects are challenging by nature, perhaps the most challenging for biopharmaceutical facilities given their complexity, the number of stakeholders involved and the extensive regulatory requirements, but, with the right team, a good plan and an established process, even the most difficult and complex construction projects can be completed in a fast-track manner with optimal results.
CRB specializes in listening to clients and determining their specific fast-track designs. We begin this process by considering the purpose of the facility and designing it around our client’s budget. With our fast-track approach and transparent, collaborative relationships, we have been able to reduce project timelines from 20 months to one year, which enables our clients to get their novel therapies to patients much faster.
Our ONEsolutionTM process is a genuinely integrated approach. Unlike large construction firms that hire architects and engineers and assign them discrete tasks, CRB is a full-service firm. We can provide support at any stage of a project — from operations improvement to predesign and pre-construction through procurement and construction. Our integrated teams of architects, designers and engineers work with one another daily. These cohesive teams have expertise in supporting clients from the conception of an idea for a facility to the initiation of operations.
CRB’s operations improvement team has the experience, knowledge and ability to assess the current operations at a facility and determine what needs to be done to make it run more efficiently in terms of productivity, energy consumption and personnel movements. This information is used to inform the design of the new facility. However, in some cases, the team identifies basic steps that can be taken to sufficiently improve operations, eliminating the need for a new facility entirely.
Small Company Service
The operations team is just one example of how CRB, despite being a worldwide organization with nearly 1,200 employees, can perform like a small company when appropriate. Projects are led out of local offices with teams of people accustomed to working together. Team size and composition vary depending on the size and type of facility.
Larger projects are managed by a project director in charge of design who is supported by design and construction project managers. These three individuals serve as contact points for the customer. Mechanical, electrical and process leads and engineers of various types may work on the design team. Construction managers, superintendents, engineers, estimators and safety staff are typically part of the construction team. Smaller projects, on the other hand, may have as few as three people. The team is tailored to the project to ensure the leanest solution that can provide the best possible results for both the client and CRB.
Keeping Our Purpose in Mind
At CRB, we feel lucky to be involved in the pharmaceutical industry and to have the opportunity to be in a position to help people by bringing facilities that manufacture lifesaving medicines to fruition.
Many of our recent projects are intended for the production of next-generation therapies, including cell and gene therapies and other biologic drugs. One recent example was a facility in Pearland, Texas that remains the largest dedicated cell and gene therapy manufacturing facility in the world. These facilities are highly complex, and completing their design and construction in a fast-track manner is not easy. Unless properly managed, there is a potential to get bogged down by day-to-day responsibilities because we are constantly working to ensure that everything is done right.
To avoid this common issue, we make a point of taking a step back to remember why we are pursuing the fast-track approach. The reason we are in such a rush to build the facility and make it operational as quickly as possible is that these manufacturing plants produce treatments that in many cases can cure diseases that previously could not be treated in any way — especially for pediatric patients. When working long hours to move fast-track projects along, thinking about those patients gives us a real sense of purpose and makes our efforts that much more worthwhile.
Article originally published in Pharma’s Almanac | December 6, 2019