The Director of SlateXpace Global Operations walks us through his career, from being a newbie in the world of controlled environments, to taking the spotlight in a COVID-19 vaccine facility build, and finally to being in charge of the launch of a whole new construction concept
Engineers are the bedrock of cleanroom construction, and no one embodies this more than CRB's James Bornholdt. Prior to working at CRB, Bornholdt was a Registered Architect and a Professional Engineer, but with his experience limited to commercial and institutional design and construction. However, over his more than six years at the engineering, architecture, and construction firm, Bornholdt has gone from being a newbie in the controlled environment sector to the man with all the technical jargon.
"I had the good fortune to immediately pick up a senior mentor with 30+ years of experience designing mechanical systems for cGMP and controlled environments," Bornholdt recalls. "He walked me through the first principles of cleanroom design and construction, which formed the base for the knowledge and experience I've since gained."
Many of our perceived competitors take the opposite approach
When talking about previous experience, Bornholdt says that his background as an architect and HVAC engineer meant he found a natural niche at CRB. Considering his current role designing controlled environments, he says that this has been a tremendous asset.
Like many, Bornholdt served in a lot of roles in his effort to climb the ladder. He went from his starting position as a mid-level engineer but has also served as Process Architect, Bio-Process Engineering Group Lead, Lead Project Manager, Project Architect, and even Advanced Energy Building Modeller. This diverse experience is something Bornholdt specifically advocates, "I continually strive to gain new knowledge and experience across various disciplines."
Flash forward to today and Bornholdt's day-to-day duties have completely transformed and he is at the forefront of his company's latest and most innovative concept, as the Director of Global Operations for CRB's multi-modal and multi-product manufacturing platform for the biopharma industry. "Today I'm responsible for managing and maintaining the quality and consistency of CRB's SlateXpace (registered trademarked) brand," he explains. "We've been developing this product line in response to a need we saw in the biopharmaceutical market."
Though Bornholdt talks about many turning points in his career, a project that he seems to have a lot of passion for is the Novavax warp speed project. Being in the global spotlight, these COVID-19 vaccine facilities were under intense pressure and Bornholdt says it caused a paradigm shift in how he approaches biopharma facilities. "It underlined the sudden (and lasting) importance of new and unique drivers that we at CRB had noticed in the Cell, Gene, and Advanced Therapy markets for several years but which the industry at large hadn't faced before."
Knowledge across disciplines is a rare and high sought after trait in the workforce. In a supporting industry, such as cleanroom construction, even a rudimentary understanding of the processes involved in the final product is hugely helpful in allowing a proactive approach.
As the SlateXpace is targeted at the biopharma sector, Bornholdt feels that this knowledge influenced its concept development. "I'd encourage others interested in the biopharma sector to learn as much as possible about the science behind the therapies we help our clients manufacture," he says. "A solid understanding of this area makes a huge difference in effectively communicating, designing, and building solutions that solve our client's most critical and important challenges."
Continuing with business as usual will fail to meet biopharma needs
Once he had an understanding of these new curative therapies, Bornholdt says he determined that the likely focus on low volume but high-quality products was going to have a major impact.
He talks about the concepts of 'scaling down' (making advanced therapy processes fit within modular boundaries) and 'scaling out' (the ability to expand or repeat the project). "This 'scaling down and out' of process operation and an increased focus on facility flows to prevent mix-ups and cross-contamination is already apparent in many facilities under construction today," he says. "Equally important is the sheer quantity of therapies under development. Production pipelines and production processes of that past were well developed and required relatively minor facility modification from product to product. The rapid development of novel therapies, such as RNA and LNP related therapies, creates uncertainty in the market like never before.
The biopharma industry's focus on regenerative medicines at the moment comes with some inherent issues. Seeing the whole picture, and predicting these problems that clients may incur even though it might be slightly out of your remit, is often a defining trait of a good contractor.
This is what Bornholdt is attempting to do with SlateXpace to solve the hurdles with 'scaling down and out'. "We see an unprecedented desire to move away from global production centralised at one or several sites. Manufacturers seem to be moving towards a decentralised strategy that favours repeatable production in local and sometimes remote areas which previously had little to no experience with the biopharmaceutical industry."
Bornholdt says that the development of such 'global modular facility deployments' could likely be the next seismic shift in the way we approach manufacturing facilities.
Noticing these trends from watching over the biopharma industry, Bornholdt knew that something would have to change, and soon. The launch of the SlateXpace in late 2020 was a huge moment for Bornholdt and his team, and a concept that came from stepping back to see the big picture.
Bornholdt explains relatively small patient populations and subsequent heavy competition in regenerative therapies means the first to pass clinical trials and enter commercial production gains a tremendous advantage. "This drive for speed is very different from what the biopharma industry has seen traditionally and requires rethinking the stage-gate schedule barriers associated with traditional design-bid-build," Bornholdt says.
"Nearly every traditional cleanroom design I've been involved with struggled to lock down the process definition with adequate confidence to avoid impacting cost and schedule later in the project," Bornolhdt explains. "We realised the recent desire for multi-modal manufacturing paired with a desire for accelerated schedules and speed to market were very much at odds, and the existing challenge would quickly come to a breaking point with a business as usual approach."
Seeing the issue was the first step, and allowed the team to choose a proactive approach to the problem rather than having to problem solve each individual project from scratch. Taking the 'scale down and out' concept and factoring in these 'time to market' demands was quite a feat. Bornholdt explains that standardised design solutions based on a curated set of best practices streamline the front end of the project, while Prefabrication, Preassembly, Modularisation, and Off-site Fabrication (PPMOF) accelerates the back end of a project.
The Director talks about a job he did for a local biotech CDMO in the US that showed how useful this could be. "[The CDMO] was an early adopter of some of the technologies and approaches that made SlateXpace possible. And now, many of the big pharma players are now borrowing a CDMO mindset in response to the rapid diversification of the biopharma market in recent years."
Bornholdt explains that the unique part of the platform is that it combines many advantages that no single competitor currently provides. He says that though it often gets lumped in with modular cleanroom providers, this is not quite a direct comparison. "Modular delivery and construction is certainly a helpful tool; however, it is merely a means to an end from our perspective," Bornholdt explains. "CRB is focused mainly on the process design and facility integration," he explains. "However, we often are compared to modular cleanroom providers or vendors. We start with a deep understanding of the process and build the cleanroom around that. Many of our perceived competitors take the opposite approach."
Aligning with Bornholdt's predictions about 'global modular facility deployments', SlateXpace's appeal to established global and international clients has been a growing trend despite its intended target being the US. "We've also seen strong interest from developers looking to enter the life science market, especially the potential creation of a new market for leasable or speculative cleanroom."
Bornholdt is rightfully proud of his achievement with SlateXpace and reveals that in the early part of 2021 the company started the process of arranging a full-time team dedicated to supporting the SlateXpace offering.
Talking about other current trends and issues like variable air change rates, prefabricated facilities, and the pandemic, Bornholdt's discussions show he is highly tuned in to the direction of the controlled environment industry.
The approach he seems most interested in is advanced energy modelling and its link to sustainability. His thinking seems to revolve around optimising the processes themselves as a route to meaningful change. "From an environmental standpoint, reducing water usage and waste seems to have the most potential for improvement," he says. "Closing the process decreases the need for energy-intensive environmental control, reduces building footprint by eliminating airlocks, and reduces waste consumption by reducing gowning and cleaning procedures."
Nearly every traditional cleanroom design struggles to lock down the process definition
The need for sustainability and the pressures of the pandemic over the past two years have pushed the industry to its limit, while simultaneously raising expectations for the future development of new and/or expanding facilities.
With these two factors, Bornholdt feels that approaches and solutions like SlateXpace are necessary to meet this new market demand.
Bornholdt feels that recent earth-shattering but seemingly unrelated events and advancements will likely have permanent effects, which our industry must address. Continuing with business as usual will fail to meet the needs of biopharmaceutical manufacturers - and more importantly - fail to meet the needs of patients awaiting critical life-saving therapies. "Most importantly, [we must] always remember that the fundamental purpose of manufacturing biopharmaceuticals in a cleanroom environment is to protect the patient. Everything else comes second to this."