Sr. Fellow 
Aseptic and Sterile Products
CRB Group

Christa Myers

At INTERPHEX 2026, Todd Vaughn and Christa Myers of CRB Group discuss rising automation in aseptic manufacturing and growing regulatory focus on sterility.

Robotics in the Aseptic Core: Rising Urgency, Rising Expectations

In part 1 of a multi-part video interview on day one at 

, CRB Fellows Todd Vaughn and Christa Myers discuss the expanding role of robotics and automation within aseptic and sterile pharmaceutical manufacturing, as well as what it means for operations and regulatory compliance.

Both experts note that robotics in the aseptic core is not a new phenomenon but that the pace and urgency have shifted considerably. As Myers explains, "This is not the first period of time that robotics have gone into the aseptic core, but we're seeing a lot more information about it right now, and regulatory is dramatically more interested in it now than they have been in the past." The driving force behind this regulatory interest is sterility assurance and, ultimately, patient safety, moving away from traditional fill lines for which personnel worked in close proximity to the product toward greater separation between operators and the final drug product.

Vaughn highlights that while the direction is clear, execution is complex. "It's not going to be straightforward right away, but it's a challenge I think the industry is ready to take on as a whole." Removing human operators from the process requires anticipating every possible failure scenario and engineering automated solutions to handle them, a significant upfront investment in both planning and cost.

Myers adds another layer of complexity: teams must now plan not just for expected interventions, but for unexpected ones, requiring deeper, earlier engagement in the design process. The industry's response has been a strong appetite for data, with manufacturers and design partners building robustness and data collection into facility and line designs from the outset.

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During the COVID-19 pandemic, speed-to-market in drug manufacturing went from important to "mission critical"—and that is not changing anytime soon. CRB conducted a survey of 500 life and biopharma leaders, and when survey respondents ranked their pre-pandemic business drivers, speed-to-market came second-to-last. After the pandemic began, however, it shot to the top of the list of must-haves for drug developers (1).

This newfound focus on speed brings along some challenges. So what has the industry learned over a year and a half of “warp speed” vaccine development? How can those lessons impact drug discovery and manufacturing timelines? And what does the need for speed mean for the future of capital planning and project delivery in the pharma industry? To find out, CRB asked survey respondents how they plan to keep up with the pace of change and overcome obstacles. The following sections discuss some key takeaways.

The pandemic brought the fragility of the supply chain to the forefront for many facilities. During the US government’s push for vaccine development and manufacturing (dubbed Operation Warp Speed)—and partly because of it—capital projects struggled to acquire adequate construction materials and equipment. Then, as facilities shifted into startup and operation, teams were tasked with sourcing chemical, commodities, personal protective equipment, lab materials, and other supplies amidst scarcity. Supply shortages and late deliveries plagued almost every project.

The industry, however, is proving to be nimble. In fact, 85% of survey respondents aren’t experiencing challenges as frequently as they were before the pandemic. It seems that drug companies and their project delivery partners have developed new and flexible strategies to navigate and de-risk their approach to resources, such as phased delivery.

The main key is putting those strategies in place early in the delivery process, so that companies can secure access not only to building materials during construction but also to the manufacturing resources that are necessary for startup and operation. These proactive strategies will help industry meet today’s project delivery demands, despite ongoing interruptions in the global supply chain. One of the more interesting supply chain shortages for the industry is the availability of glass for vials for parenteral products. There is an unmatched pressure on this part of the supply chain currently that is affecting all injectable products. It is even difficult to source non-production samples for machine design. This is driving innovation and is forcing drug delivery devices to change. Many companies that had shelved more novel injection devices are looking again at their research to be able to distance themselves from this glass shortage (1) .

. Companies of all sizes are now trying to establish relationships with the consulting, design, and construction partners they’ll need to meet their speed-to-market goals. Project delivery partners are still in short supply. The key to addressing this shortage is to find partners capable of keeping schedules on track by establishing a phased project delivery approach. A flexible partner can tailor their delivery roadmap to align with both the manufacturer’s target milestones and their own available resources, which could mean breaking the overall business case into discrete packages. For example, if the goal is to have a facility with four production lines running at full capacity in five years, for example, a partner could develop a plan to design and launch two production lines in the short term, while leaving spare capacity for future expansion. This strategy addresses a manufacturer’s goals in a way that’s realistic, controlled, and in tune with available resources and supply chain activity.

The pandemic eliminated the luxury of time. It was no longer logical to wait for every piece of information before taking projects forward. CRB’s clients who participated in Operation Warp Speed found that all of the various project components—design, engineering, construction, and vendor coordination, as well as all of the owner concerns—had to move forward in lockstep.

One of the secrets to success amidst accelerated timelines was fully leveraging online tools to coordinate activities and prevent pileups. Once social distancing came into play, face-to-face interactions were replaced with video calls. At the same time, teams made fuller use of programs to organize all project documents so everyone could comment or write on the drawings and sets simultaneously, and in-progress drawings were made available for early review. Additionally, video production equipment was leveraged to offer an overview of progress in real time and even perform equipment testing. Operations and maintenance personnel could be in one part of the world reviewing and testing equipment in a different part of the world, multiple time zones away.

At the same time, the design, engineering, and architecture teams leveraged various building information management and virtual design and construction programs to coordinate closely with trade partners and installation crews. This tactic allowed construction to begin much sooner than by using traditional delivery methods.

Social distancing changed the way manufacturing and lab spaces and the need for automation are perceived. Dissatisfied with traditional manual labor methods and galvanized by the need for personnel protection and uninterrupted production, many project leaders are turning to faster and more automated, agile solutions. They’re leveraging the predictive capabilities of artificial intelligence and machine learning to build smarter, more secure, and future-ready manufacturing centers.

Perhaps contract development and manufacturing organizations (CDMOs) have never shone brighter than during Operation Warp Speed. Even before they were faced with the urgent need for available capacity for vaccine candidate manufacturing, CDMOs were already expanding to serve unmet needs in the industry. When the unprecedented speed and scalability needed for COVID-19 vaccine production was identified, this capacity was relocated. More manufacturers of different COVID-19 vaccines are currently planning and building capacity. There is also planning to ensure future pandemics can be managed with research and development, and fast implementation for rapid manufacturing deployment. CDMOs also continue to add capacity to support manufacturing for earlier unmet needs.

Large companies are best positioned to limit their reliance on outsourced manufacturing. For one thing, they are more likely to have the capacity and the capital to vertically integrate certain operations—such as the critical fill-finish step. Startups, however, are especially dependent upon leveraging CDMOs because they are typically operating with less capital, less infrastructure, and a great deal of pressure from investors to get product to market as fast as possible. That’s likely why 73% of survey respondents from this group plan to rely on contract manufacturing organizations and CDMOs exclusively when it comes to production (1). But companies face a significant challenge: demand currently outstrips supply, and many contract manufacturers have prohibitively long lead times. In short, startups are competing for a few outsourced manufacturing slots.

The main solution to limited manufacturing opportunities is to work with a consulting partner who can help them accelerate the process of finding, prequalifying, and negotiating with appropriate and available contract manufacturers. A good partner will go even further, though, helping startups review their business case with alternative options in mind. If a drug developer faces a five-year wait for capacity with their CMO of choice, for example, but they could build a small-scale manufacturing operation in just two years, they may come out ahead; the value of getting their product to market three years sooner could more than offset the cost of constructing and operating their own commercial facility. And if they design future flexibility into that facility—by integrating multimodal equipment platforms, for example—then they could be at an even greater advantage, particularly as they grow and diversify their product portfolio over time.

Develop a long-term manufacturing plan. As they mature, many drug developers will choose to bring manufacturing under their own control, but this takes both time and capital. It’s therefore important to start with the business case first or the “why”. This not only brings value and innovation throughout the duration of the project, it also provides flexibility for many years to come. A relentless focus on the business case is key to controlling cost and schedule, reducing risk, and maximizing value. To succeed, these manufacturers will need a flexible, phased approach to project delivery that can withstand the pressures and turbulence of a market in constant motion without losing momentum. It is crucial to think about a speed-to-market strategy holistically and not simply in terms of getting to the next phase. Looking ahead to late-stage clinical or to good manufacturing practice manufacturing will help drug developers stay ahead of obstacles. The earlier that risk management practices can be integrated into plans, the more effective these plans will be in the long run.

The pandemic and its accompanying acceleration of vaccine manufacturing required drug manufacturers to rethink the way the industry operates as a whole. Moving COVID-19-related projects from kick-off to commercial manufacturing in record time required an enormous, coordinated effort, both from those inside the pharma industry and from the general public. And now, all things considered, it seems warp speed is the new cruising speed in life sciences manufacturing.

1. CRB, “Horizons: Life Sciences,” November 2021.

Christa Myers is a process chemical engineer for CRB.


Vol. 46, No. 1
January 2022
Pages: 32–33

When referring to this article, please cite it as C. Myers, “The Need for Speed: How Operation Warp Speed Shifted the Pharma Industry,” 

Articles

A new focus on speed to market creates challenges for facility design and construction.