Remaining Nimble in Biopharma Construction and Engineering

David Alvaro (DA) of Pharma’s Almanac: What can you tell me about how Genesis AEC is positioned among your peers and competitors in the market?

Meryl Towarnicki (MT): We’ve recently put a lot of effort into making sure that the market understands who we are as a firm. We have evolved rapidly over the last ten years, adding subject matter experts (SMEs) and services, such as process architecture and engineering, to fit our clients’ changing needs. As such, we’ve been on a campaign to reeducate our existing clients and the industry about our full-service capabilities. We’re ranked fifth in Pharmaceutical Design by Engineering News-Record (ENR); and within our sector we can compete with firms much larger in size. In fact, we bid on the same RFPs as some of our larger competitors. Although we’re a smaller, nimble, quality-focused AEC firm, we’re as equipped as the bigger players.

DA: Genesis AEC does a lot of work with biotech startups. Do you think those kinds of companies are an ideal organizational fit for the firm?

MT: Startups are often looking as much for guidance as design/build services, as they haven’t been down the path of creating a facility before. We’re a good fit for these companies because we can deliver an economical turnkey facility. For these young companies, they can struggle to get the attention that they need from larger firms. We’re quite in tune with helping startups develop their business plan for their facility, and, when we begin to dig into the details of their project, we are adept at demonstrating that to them. For example, we have a client who needed to add on new operations and thought that they would have to lease the adjacent space to accommodate the expansion. After one meeting, it was clear that we could provide consolidated lab space, an area for pilot scale functions, and a cGMP suite all in their existing location. They used this information in a board meeting to secure funding, and it demonstrated our skill in helping with their business plans beyond just the design and construction project.

But that’s not all — Genesis has clients from small startups to Big Pharma, CDMOs, and CMOs; with our size and skillsets, we can play in every arena. We’ve gained a lot of experience with various project sizes all along the drug development process, and we’re open to all types of clients. Of course, larger companies come with different standards, as well as a little more bureaucracy, which we are nimble enough to navigate. We can also right-size our services for smaller clients that prefer to be more independent and require a more economical fit-for-purpose project.

DA: What do you see as some of the longer-term impacts or ways that the post-pandemic world is going to be fundamentally different than what came before?

MT: I’ve never been a believer in going backward. It’s clear that the way we work and the expectations of where our employees need to physically be have permanently changed. That added flexibility can help all of us have a better work/life balance. The pandemic has also pushed us to look at design and construction differently. Even pre-pandemic, Genesis was pushing the limits of ready-made construction and bringing more assembled sections to a jobsite. Offsite fabrication is the future for improving quality, safety, and speed. In fact, our clients are the real drivers of change, as they need facilities up and running faster than ever before. Any EPCM must find a way to accommodate to remain competitive.

DA: How does one determine the best approach for a given project on the spectrum of modularity between traditional, fully stick-built construction on one end and a totally prefabricated or “podular” model on the other extreme?

MT: I think the best approach depends on the therapeutic the facility is designed for. Certain therapies can be manufactured in a small space — such as the “podular” concept of a “lab in a box.” While that might be applicable in some cases, other situations require more of a middle ground — some parts of the facility may be modular, while other parts just make more sense to build in a more traditional stick-built method. The approach will always be project specific and what is best for a particular client. Regardless of the approach, clients will always expect projects to be completed as soon as possible. Ultimately, we’re going to have to follow the science — there’s no such thing as a “one size fits all” approach to architecture and engineering, especially for pharma projects. Everything depends on the therapy type and the production requirements; you can make one drug for thousands of people in one type of facility or an autologous therapy that’s specific to one individual that is produced in a hospital setting.

DA: How has the Genesis AEC service offering evolved over the last few years?

MT: As I mentioned, we have added new offices as we’ve grown, which has helped attract more talent. We’ve invested in process architecture and process engineering to support our manufacturing clients, which has allowed us to build our portfolio and experience. In terms of technology, we’ve purchased 3D printers, which are used in traditional ways such as creating site models, but we also use them to create scale models of laboratory and process equipment. These “doll-house” pieces are instrumental during programming meetings for clients to understand the design and contribute to the solution.  We want our clients to achieve the best sense of space, which is why we’ve also introduced AR technology, which allows users to see three-dimensionally and interact with the proposed space. These advancements help the design process and aid in decision-making.

We’re constantly being challenged and pushed by our clients to finish builds faster, which trickles down to the design process happening in parallel with bidding and building a project. I think architects and engineers must become a little bit more comfortable with the shifts in our industry. Pharma (and especially biotech) is pushing us to deliver faster than ever, and we’ve got to innovate to keep up; that’s going to be a key differentiator between firms.

DA: In terms of technological innovation, is there anything on your wish list that you can conceptualize and would make things a lot easier but isn’t yet available?

MT: The way companies manage their own facilities’ data is extremely inefficient — and often inaccurate; one of the first steps for an architect and engineer when they start a new project is to physically survey the existing space, and this happens repeatedly for a client on every single project. I believe that there would be tremendous benefits to a technology that helps clients create building information models of their existing space — more than just laser scans and cloud points — that they can hand to their service providers. Millions of dollars are spent to constantly capture that data. Having inaccurate information of an existing facility is a huge roadblock, and simply can’t be left out of the Industry 4.0 movement. You can’t revolutionize what happens in a facility if the data regarding the facility remains unsophisticated.

DA: I would imagine that, in order to prepare for trends before they even really manifest, the company needs to always be actively researching these things to develop a good understanding even before customers start asking, so you’ll know how to advise them as to what’s feasible and what’s not or give them new ideas to consider. Can you explain how you stay on top of trends?

MT: At Genesis, we are always promoting education and training. Whether it’s through vendor contacts that we turn to for new products in the industry or conferences, seminars, and workshops. We always try and remain current or a little ahead of latest trends.  Many clients can be resistant to change, but we still educate them and bring new ideas to the table.

While the next big thing is definitively elusive, at Genesis, we remain open-minded and nimble. Part of this means always being ready to jump in and support clients with whatever might be needed for their facility. I think that our approach is conducive to aiding clients with what’s next — because they don’t always know either — which is why they’re looking for qualities like flexibility, adaptability, and speed in a partner.

Originally published by The Pharma’s Almanac.

Glossary:

• Process Architecture: A specialized field within architecture that focuses on the design and layout of process facilities, such as labs and manufacturing plants.
• cGMP Suite: Current Good Manufacturing Practice Suite, a section of a facility that complies with regulations for quality and safety in manufacturing.
• CDMOs: Contract Development and Manufacturing Organizations, companies that offer both development and manufacturing services.
• CMOs: Contract Manufacturing Organizations, companies that offer manufacturing services.
• EPCM: Engineering, Procurement, and Construction Management, a form of contracting arrangement used in the construction industry.
• Podular: Refers to prefabricated or modular laboratory or facility spaces, sometimes referred to as a “lab in a box.”
• AR: Augmented Reality, technology that overlays digital information or graphics onto the real world.
• Industry 4.0: The Fourth Industrial Revolution, involving the integration of smart technology into manufacturing environments.

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