Every plasma fractionation project comes with a constellation of complex elements ranging from upstream processes to downstream ones, low temperature requirements to clean room needs, regulatory must-haves to building code must-dos. With so many moving parts to keep track of, stakeholders may be hesitant to try out novel project delivery methods when kicking off a new project. There may be comfort in sticking with traditional methods—but it also puts facility owners at risk of missing out on the major benefits of modern project delivery methods.
Few methods unlock those benefits better than integrated project delivery (IPD). You may know of it under different banners (at CRB, we package IPD as the core component of our ONEsolution™ delivery approach), but IPD, wherever it’s applied, has earned itself a reputation for marshalling even the most ambitious projects towards successful and timely delivery. If you’re a project leader in the plasma fractionation market, you would do well to notice this trend and harness it as a vehicle for your next capital project. The plasma fractionation industry is especially well-positioned for IPD in three key ways:
- The predictability of its projects
- The opportunities afforded by joint ownership of projects
- The depth of technical expertise required to execute each project
1. Predictability as a means for speed and success in the plasma fractionation industry
The tight margins and demanding schedules within the plasma fractionation industry set it up perfectly to benefit from a modern, integrated project delivery approach.
Benchmarking with historical plasma fractionation data
Drawing on over 70 years of established plasma fractionation methods, the industry has a rich archive of data and experience to reference as it moves forward. Unlike some newer pharma and life science industries, plasma fractionation stakeholders have predictable benchmarks to assist in looking ahead, making decisions, and developing a solid business case.
Before digging into a new project, stakeholders will be able to lay out accurate benchmarks to inform their design decisions and budget, such as:
- Target yields
- Projected process cycle times
- Vial size
IPD can transform all of this known/predictable data into a shorter schedule, cost-certainty, and higher quality than the traditional delivery model—mainly because it’s premised on completing work packages simultaneously, rather than sequentially.
If you know where you’re going, and you know what’s necessary to get there, you can strategically orchestrate concurrent activities to shave significant time off your schedule. One of the best ways to do that is through offsite construction, a central facet of IPD.
Prefabrication, Preassembly, Modular, Offsite Fabrication (PPMOF) strategies for plasma fractionation projects
One low-hanging fruit in plasma fractionation projects is the plethora of opportunities for PPMOF —often referred to simply as “prefabrication” or “modular construction.” This approach involves producing standardized components of a structure off-site and then assembling them on-site. PPMOF allows many elements to be accomplished in parallel without interfering with each other on site. This works particularly well for plasma fractionation facilities due to repeating elements and systems. It’s a great way to maximize value by bringing in the right pieces at the right time for on-budget and on-time delivery. Put simply, PPMOF accelerates timelines.
Consider a renovation project where six new buffer tanks are being added to an existing facility. Chances are, these will be nearly identical units. This means that every aspect of them can be modular—from the valves to the piping to the pumps. One particular advantage to this approach is that it creates access to skilled labor in fabrication shops perhaps not otherwise available locally. In fact, the whole vessel and all its accompanying components could be assembled offsite, then skidded in, delivered, and installed safely by an expert team. This approach reduces facility downtime and other logistical challenges, such as assembling entire units in congested layouts. When as much assembly is done as possible offsite, this allows more space for workers. This means far less downtime for existing lines and sustained cash flow for the facility.
Another opportunity within plasma fractionation facilities for offsite construction is tied to its need for low temperatures throughout the entire process. The complex mechanical systems, such as pumping groups or cooling control modules, can be built offsite and then brought in as completed assemblies.
There are so many ways to get a head start in a plasma fractionation facility through PPMOF: pre-built cleanroom wall systems, prefabricated pipe racks for hygienic piping, and even skidding elements of architecture and HVAC. An aggressive goal would be shooting for 50% pre-fabrication if possible. Of course, this is only feasible by working with an integrated team, who can collaborate, coordinate, and cooperate for a smooth and fast rollout. IPD, by its very nature, promotes this kind of team mindset.
Tighten the schedule using Prefabrication, Preassembly, Modular, Offsite Fabrication (PPMOF), and the Last Planner® system. Achieve cost certainty through zero-based scope and target value delivery. Finally, ensure high-quality projects by leveraging data and expertise.
2. Joint project ownership reduces risk and increases reward for plasma fractionation companies
Joint ownership is a key advantage of IPD. In a joint ownership scenario, all partners (including the owner) combine forces to tackle the work and share in the risks and rewards according to their percentage of interest in the venture. This means that all partners are invested in achieving the conditions of satisfaction which typically include delivering a high-quality facility and optimizing timelines and budgets.
Large-scale projects—like the ones sometimes required in the plasma fractionation industry—can especially benefit from collaboration between partners due to the complexity of managing huge budgets and long timelines. Regardless of size, all plasma fractionation projects are challenged by tight margins and long timelines. Joint ownership is key to building a culture of trust and transparency between all stakeholders and incentivizes the entire team to reach their shared goals.
Early trade partner and vendor engagement
One way joint ownership creates value is through the engagement of trade partners early in the process. Trade partners that might come on early include:
- Clean room
- Cold storage
- Commissioning, Qualification, Validation (CQV)
Engaging these key players early in the process allows for earlier cost and schedule certainty than would otherwise be possible. For example, engaging a centrifuge supplier early, with market knowledge, allows for quicker shop drawing submittals and real-time constructability input. This allows for the coordination of piping and other design elements, translating into time savings, cost-certainty, and fewer surprise changes. In addition, a mechanical or electrical trade partner who is engaged early could offer real-time market costing information, leading to a more accurate estimate.
3. Plasma fractionation facilities are a platform for technical excellence
A plasma fractionation facility comes with a lot of unique needs, so a successful project hinges on a nuanced understanding of the relevant specifications and regulations. While having a roster of partners who each hold a fragment of the answer is one thing; integrating those partners into a single, cohesive and collaborative team, on which individual expertise combines to drive a collective outcome, is quite another—and that’s where the rubber of IPD hits the road.
Code and regulatory requirements for plasma fractionation
Both traditional and new methods of plasma fractionation require specific technical knowledge of biotech and pharmaceutical fields—as well as the ability to navigate around strict regulations and facility code requirements. Having an integrated team with this expertise ensures that everyone on the team knows regulatory considerations from the start so they are less likely to run into an issue.
What happens when the team isn’t focused on regulations? Technical requirements can get lost in translation or, even worse, ignored. Consider an example: as per code requirements, all plasma fractionation facilities require flammable composition sensors (LEL sensors) to raise an alert in case of a flammable gas leak. Flammable vapors are heavier than air, so in order to function properly, these sensors need to be installed within 12” of the floor. But what if a contractor doesn’t fully appreciate the reasons behind this specification? The facility may end up with the sensors installed 20” above the floor instead. Because this can cause a layer of flammable vapors to go undetected and create an explosion, the problem must be fixed—an expensive and time-consuming setback.
Additionally, plasma fractionation facilities require clean design and fabrication. Environmental contamination is the enemy, so construction techniques and details matter—a lot! The surface finishes and the way the ductwork is assembled and installed all make a difference. For example, is ductwork sealed while it’s waiting for installation? Is it installed in a clean way so that no particulates are leaking out into the clean room? All ductwork must be protected as if it’s part of direct product contact. An integrated team can prevent costly mistakes and oversights from slowing down a project and eating into the budget.
A successful pharmaceutical production plant startup and licensure relies on project stakeholders who understand the facility’s business case from beginning to end. They need to look past mere facility completion and towards operational readiness. Plasma fractionation comes with high overhead, so it’s paramount to open the doors as soon as possible to begin recouping its investment.
An integrated delivery method will ensure activities are run in parallel to get to operational readiness faster and more efficiently. In fact, some of these commissioning and validation efforts can be done in tandem with construction. For example, automatic bottle openers and bulk bag squeezers can be commissioned, qualified, and validated before the final construction of other facility parts is completed.
There are also code requirements associated with the solvents and low temperature cooling systems used in plasma fractionation facilities, so getting a jump on the CVQ process for these will also get mechanical systems running sooner. Having team members with expertise with regulatory authorities such WHO, FDA, EMA will ensure a facility meets operational readiness at the earliest possible date.
A better way forward
The plasma fractionation industry is anticipated to grow with a CAGR of nearly 8.76% through 2025. A worldwide spike in demand for immunoglobulins is in part driven by the increasing prevalence of debilitating neurological diseases such as rheumatoid arthritis and osteoarthritis. Additionally, new plasma collection centers are popping up across the globe. The COVID-19 pandemic also triggered public interest in the potential therapeutic applications of immunoglobulins.
Of course, along with this exciting growth, facility owners continue to face unique construction and operational needs. For example, raw materials and manufacturing expenses account for roughly 60 to 70 percent of total costs for plasma protein therapeutics, which is massive in comparison to 15 to 20 percent for typical pharmaceuticals. Margins are slim, cost is critical, and, at a certain point, a facility project simply isn’t viable.
However, integrated project delivery brings multi-disciplinary teams together to accelerate plasma fractionation projects, while reducing risk and better ensuring that the myriad technical considerations for these facilities are addressed. This makes these complex projects more feasible. As we’ve developed our ONEsolution approach to IPD, we’ve seen how it provides high-quality facilities with better cost and schedule certainty—so our clients can dig into their work (and profit!) sooner.
If you’d like to discuss how IPD can benefit your plasma facility, CRB can help.