Pharma’s Almanac Editor in Chief David Alvaro sat down with Grant Merrill and Jose Jimenez of AES Clean Technology, Inc. to discuss the challenges of rapidly meeting demand for cleanrooms needed for the production of COVID-19 vaccines and therapeutics and how AES’s experience and flexibility enabled the company to rise to the task.
Q: What impact has the COVID-19 pandemic had on the demand for new cleanroom suites and facilities?
Grant Merrill: When I look back at the last year for this business, it’s really a tale of two extremes. AES serves locations all over North America, with hundreds of people working on many different projects at the same time. The COVID-19 pandemic caused tremendous disruptions, impacting the ability to travel, to stay safe, and to work on project sites with colleagues and other tradespeople. Supply chain issues, particularly the transport of key materials, compounded those difficulties.
Jose Jimenez: I would like to stress that, as a specialty contractor, we have a traveling workforce and continually self-perform. Travel was a real challenge. We had to take special steps to manage people traveling from a “hotspot” to an area with a lower case rate. Even foreman and our installers carried personal notes in their glove compartments explaining that they were deemed essential workers to facilitate travel. We were really tested and challenged with regard to travel during the pandemic, and I think it went quite smoothly given the circumstances.
Grant Merrill: On the one hand, the pandemic created new challenges that took significant effort to overcome. On the other, it created opportunities for us due to our history of rapidly delivering functional facilities for clients. We had companies we never worked with previously call for assistance getting their anti-SARS-CoV-2 therapeutics into the clinic. Many were backed by the federal government with funding and other support. Projects we didn’t even know about arrived unannounced and were completed within five months. That is relatively unheard of in this business. We normally have visibility into projects for many, many months before they even move to the actionable stage.
Jose Jimenez: From an execution standpoint, there was no boilerplate for working in this pandemic. There was nothing written; there was no reference textbook to follow. In a matter of about 72 hours, we established a war-room type center of operations and deployed the digital and cloud-based solutions needed to continue operating. Our people working from home had access to all of our project files. So that was one immediate impact — learning to work in a distributed manner.
There was also an impact with respect to business uncertainty. We initially did not know which of our suppliers and trade partners would continue working. Even though we are a one-stop shop for our clients, there are always some materials or components that come from abroad or through a third party, and we didn’t know to what extent some of those third parties might need assistance to keep operating. We had to manage our inventories and plan for worst case scenarios in the event that the supply chain became constrained.
Instant schedule compression was another big change. Like Grant said, we needed to launch and complete projects within four to five months — timelines we have never seen before in our 35 years of experience. We had to think outside the box and determine what practices needed to be put in place to meet those deadlines. The traditional design–bid–build project approach does not work under such conditions. You have to be willing to take risks, make decisions quickly, and sponsor processes that seem relatively uncertain but offer the best solution for delivering faster.
Q: For non-COVID programs that were already in the works, to what extent were projects delayed or put on hold?
Grant Merrill: Several client programs involving non-COVID-related drug candidates were placed on hold, because the clinical trials were postponed due to lack of resources at many hospitals, which were overwhelmed with COVID-19 cases. This ultimately delayed some projects that were intended to produce the drug products for use in those clinical trials. The majority of existing projects, however, continued moving forward, albeit within brave new territory.
Jose Jimenez: Operation Warp Speed (OWS) played a key role in meeting customers’ compressed schedule expectations. We would get a letter from a government official stating that a client’s project was funded by OWS and stating what obligations we had with regards to delivering materials. In some cases, that created a false expectation on the customer side that their rated project had priority over all other projects in our pipeline, which included multiple OWS-rated orders.
For the projects that were part of OWS, the military got involved with the supply chain. Military planes delivered our panels from Atlanta to the local airport near the relevant installation site. They also performed regular inspections and kept track of when crates were delivered to site, with incredibly aggressive timelines and deadlines.
Jose Jimenez: We are happy to say that, for OWS projects, AES met the expectations that were dictated to us without delaying completion of non-rated projects. It was a balancing act, but we coordinated closely to make sure we delivered on what we had promised.
Q: How did timelines shift from pre-pandemic times, and how aligned are customer expectations and the reality of how quickly projects could be executed?
Jose Jimenez: Average-size pharmaceutical facility project delivery could be a two-year process from initial concept to manufacturing of product. For projects that would normally take 52–60 weeks from design through completion of construction, we were being asked to execute them in 30 weeks. In some cases in areas adjacent to active GMP operations that are highly sensitive to noise, dust, and vibration, we made it happen with proper planning and engineering controls.
Timelines have been cut in half for those COVID-related projects. I think that in one sense it has set the bar and expectation moving forward. We have proven that if we work together, we can actually expedite and get projects done rather quickly.
Grant Merrill: Jose brings up a good example of some of the realities we face. We often have to remind our clients that creating a cleanroom inside of an occupied building still requires review of the safety profile and the compliance to local codes that are enforced by the municipality. That process may be accelerated, but it cannot be avoided. Ultimately, each project must go through a permit review and approval process before work can be safely initiated and a certificate of occupancy can be obtained for the client. Thankfully, many municipalities stepped in line with the importance posed by OWS and the need to accelerate the process. But it is important going forward that clients recognize the realities of building integration and permitting.
Another consideration for existing buildings in addition to the logistics of maintaining current operations while executing a project adjacent to them is to evaluate the utility infrastructure required to serve the project, which may or may not be sufficient to accommodate its needs. A project may not be as simple as perhaps designing a cleanroom and fabricating it off-site or creating it in components and then installing it in the field. Cleanroom facilities are intense from the standpoint of infrastructure requirements that must plug into the facility, such as power, cooling/heating/humidifying sources, process utilities, such as gases and thermal fluids, fire protection, and tele/data requirements. All of these utilities must be delivered in sufficient quantity and quality to the cleanroom project area in order to properly enable the cleanroom to function. This enabling work is critical to bringing the cleanroom facility to life, and it cannot be overlooked when delivering a fully functional cleanroom facility project.
It is also worth noting that, while this was all going on, AES was developing two unique products in the marketplace that can help leverage the speed benefits of standardization. We’ve now gone to market with Faciliflex Express, which has three distinct standardized cleanrooms: 5,000 ft2, 15,000 ft2, and 30,000 ft2, which can be leveraged for fast-track project execution based on completed designs. For clients that require flexibility but still want to leverage standardization for speed and cost savings, the Faciliflex Module concept makes use of standardized building blocks that can be configured in multiple ways to create a customized facility solution. These are examples of how AES is finding ways to take what we’ve learned through standardization and apply it more broadly. While standardization reduces flexibility to some degree, it allows every pharma company to leverage the experience that we bring to the table and the speed that we’ve been able to achieve previously.
Q: How much of your success in meeting those accelerated timelines was due to operational changes, and how much was due to your existing offerings, such as Faciliflex?
Jose Jimenez: AES was very well suited for the occasion as a design-manufacture-build turnkey operation that is vertically integrated. Our mindset is to eliminate handoffs. Every one of the projects we work on has an Integrated Project Delivery (IPD) approach to it, which in itself is a fast-track mentality. Other suppliers using a more traditional approach were forced to adapt to this strategy, but for AES, it is a fundamental principle of our business.
With very aggressive deadlines, there was a heightened level of alert and a need to understand scope, process goals, and all other aspects of the project from the outset, even making sure to keep commissioning in mind as the building design process was initiated. We were ready for the task.
Being modular also helps reduce the time required for the erection of AES cleanrooms. In conventional construction, there are at least five separate trades needed to execute the architectural build, and most of these processes happen in series. Contrast that with one trade (AES) executing activities in parallel. There is no need to frame walls, drop utilities, have an inspection before the walls are closed, and prep for and apply finishes because everything is integral to our modular architectural envelope.
I should mention the role of funding approvals here. Clients were provided funding in advance by the government, which enabled them to secure AES in advance, even though we didn’t have complete project definition due to the accelerated timelines. That required acceptance of greater risk. Companies came to AES because they knew they were dealing with an experienced partner that understands how to go about budgeting and scheduling these types of projects, affording some sense of control over that level of risk.
Grant Merrill: One interesting aspect that is relevant to COVID-19, and also to other applications, is the inherent flexibility AES brings to the execution of projects. The vaccines against SARS-CoV-2 that have received emergency use authorizations from the FDA were developed in months, not years, and were never manufactured at an elevated scale until they were being manufactured at full scale. The process evolution was monumental and in real time — kudos to the scientists and process folks who engineered these products — with facility requirements remaining fluid even during the deployment phase, owing to the fact that many aspects of development were performed in parallel. AES’s ability to be flexible and adapt as clients further understood their process needs was a crucial facilitator of this process. This level of facility installation flexibility is not possible with other facility build methodologies, and it was highlighted over and over during these fast-track projects that were evolving until the day that they were ready to make products.
Q: How much experience did you have in working on projects with that inherent risk and uncertainty, and how did that help with the newer COVID-19 projects?
Grant Merrill: When drug candidates first enter clinical trials, there is rarely certainty that the drug will succeed. Many clients manage this uncertainty by building flexible manufacturing facilities that can produce a myriad of different products, depending on how each product progresses through early- to late-stage trials. As a result, we have built our business around being flexible, up to and including the late stages of the project. That skill set was truly advantageous and widely deployed for COVID-19–related projects.
Jose Jimenez: In contrast to our flexible approach to modular project execution, it is possible to construct stick-build cleanrooms or pre-built trailers, but making changes in both cases can create issues. Framing and drywall in stick-built facilities must be demolished, which creates substantial contamination from dust and debris. With pre-built trailers, there could be challenges with modifying configurations based on structural or physical limitations,. Our methodology is especially tailored to facilitate late-stage flexibility.
Q: Apart from the increased urgency, what else about the COVID-19–related projects distinguished them from typical projects?
Grant Merrill: One of the biggest differences was that all of our employees knew they were working on projects with the potential to impact millions of lives around the world. For many projects that we historically worked on, there is limited visibility into the nature of the drug candidate and its mission in medicine. So there are many layers of the project team that don’t even know why the facility they are working on exists. This is a circumstance of creating facilities for the life science sector, where secrecy is critical to a client’s competitive advantage. But to participate in a national response was really meaningful for everyone in the company, and it certainly went a long way for our staff to know that COVID-19 vaccines which could end the pandemic were produced in AES cleanrooms. That’s very exciting both personally and professionally. In fact, about half of all vaccines in the United States will have been touched by an AES cleanroom in one way or another.
Q: What other lessons has AES learned over the course of this process that will be applied going forward?
Grant Merrill: One thing we have seen with our clients is their interest in tightening up the supply chain. We certainly see that as a future driver for business in North America. AES, too, has become more risk-averse with respect to far-reaching and multi-link supply chains. The lesson we’ve learned is: the more we can be vertically integrated, the better; because we can maintain the control that our clients expect from us.
Jose Jimenez: Another lesson learned relates to contracts, and particularly incorporating contract terms that have the right level of protections with respect to delays for reasons beyond our control. We were fortunate to have all of the parties involved be sensible in light of the challenges we all faced during the pandemic. Through audio calls and executive negotiations and leveraging the creativity of our staff and our customers, we were able to establish agreeable terms that addressed the uncertainty created by the effect of the pandemic to the supply of materials. That success was a big lesson learned as well.
Grant Merrill: In addition to all of the efforts put toward designing, building, and installing cleanroom facilities for COVID-19–related and other projects, we maintained our focus on creating new products that leverage our continuously expanding knowledge and expertise. Faciliflex Express is a perfect example. While all of the hectic, unplanned events related to the pandemic were going on, AES continued to keep its focus on the future. Our charter since the beginning has been to develop the best cleanroom solutions possible. We didn’t set that aside during the pandemic, and in fact we’re just hitting the next phase with the release of new products.
Q: What do you think are the key attributes engrained in your operations that made all of this possible?
Grant Merrill: We know we’ve got to focus on making business decisions that ultimately benefit the patients who need the treatment coming out of the facilities that we create, and sometimes those are hard decisions. Sometimes those are long nights or long weekends solving problems and creating solutions. But, at our core, we are problem solvers. And because we are inherently flexible in the way that we work, we have been able to weather the pandemic and help our clients stay focused on the patients that they serve. Of course, we had no idea what we were up against when the pandemic began, and now when we look back, we are proud that our hard work enabled us to achieve so much. We would love to not have to experience this again in our lifetime — to this level, for a lot of reasons. But we’re grateful for where we are today and the lessons that we have learned, and we know that we are ready to solve the next challenges that our clients face.
