by Shwetha Ravi Devine, Lead Process Engineer, Arcadis
Introducing a new product into a fully operational biopharmaceutical facility is one of the most complex programs a client can undertake. The facility is already running. People are working. Product is moving. And now the team has to layer in an entirely new manufacturing process without disrupting any of it.
As Lead Process Engineer on a new product introduction (NPI) project for a major biopharma client in 2025, I experienced firsthand how quickly the complexity compounds. On the client side, internal alignment on the facility modifications was difficult. On the engineering side, our team had to deliver a quality design with limited visibility into the product itself. (Clients cannot always share proprietary process details with outside firms, but the engineering still has to work. Adapting quickly and asking the right questions becomes the core skill.)
I had a similar experience on an earlier NPI engagement with a different client. The pattern always seems to be the same: scope starts manageable, the constraints of the existing facility become apparent over time, and the project team has to respond faster than anyone planned.
What are the most common challenges in new production introductions at existing facilities? This article can help anticipate those challenges before they become problems.
Start with a feasibility study
Before any design work begins, the project team needs a realistic picture of what the new product introduction will actually cost. That means undertaking a feasibility study well before any commitments are made.
Supply chain costs have changed dramatically in recent years. A rough estimate that felt accurate six months ago may no longer reflect current material and equipment pricing. Concept studies and early feasibility work, therefore, are necessary to set credible expectations for budget and schedule, and to give leadership the information they need to make a go or no-go decision with confidence.
The feasibility study should address several questions simultaneously. Can the existing facility physically support the new process? Does the equipment have the necessary capacity to accommodate the new product? What modifications may be required, and what is the rough cost range? Are there regulatory implications to the changes? What is the realistic impact on the existing product schedule? None of these questions has a simple answer, but framing them early prevents the team from committing to a path before the real constraints are understood.
A feasibility study won’t eliminate uncertainty, but it does give the client and the engineering team a shared baseline. That baseline is essential because later in the program, some hard decisions may have to be made.
Tech transfer: The foundation of the whole program
In new production introductions, technology transfer refers to the process of what goes into manufacturing a product that has been developed in one facility and setting it up for manufacture at commercial scale in the target facility. It is the technical foundation of any NPI program, and it has to be understood before engineering design can proceed.
Tech transfer covers upstream activities like cell culture and fermentation, downstream activities like purification and filtration, and, where applicable, fill and finish operations. At each stage, the team must demonstrate that the new process will produce the desired yield and potency in the existing equipment or in the modified equipment that may need to be installed.
One area where things get complicated quickly is filtration technology and buffer preparation. Moving from small-scale to large-scale filtration often means shifting from one filter format to another. A process that used POD-style filters in one facility may require CUNO-style filters to work in another. That switch can affect equipment selection, hold time validation, buffer volumes, and sometimes the physical layout of the manufacturing suite.
More importantly, the filter technology selected at this stage often can shape a facility's flexibility for years to come. If the team locks in a single filter type without considering future products or expansion scenarios, they may run into roadblocks with their next NPI. Those kinds of downstream consequences are easy to miss under the pressures of planning. The solution is to have tech transfer team and the facility engineering team – in fact, all the stakeholders –in the same conversation early, not working in their respective separate silos.
Large equipment and sizing problems
New products frequently require new equipment. That equipment is often large, and large equipment in an existing facility creates problems that are not always visible until it is almost too late to solve them affordably.
Ultrafiltration skids are a good example. Ultrafiltration is a membrane-based separation process used to concentrate or exchange buffers in biologic drug manufacturing. When a new product requires this capability and the existing facility does not have it, the team has to add a skid. Ultrafiltration skids are not small, and the space available in an existing manufacturing suite may not be sufficient. Ceiling heights, column spacing, door clearances, and floor load ratings all have to be taken into consideration in the planning phase.
As a result, what may have started as an equipment procurement can easily morph into a construction project. The manufacturing suite may need to be reconfigured. Load-bearing elements may limit where the skid can go. Utility connections may have to be extended or modified. The cost and scheduling impact of a single piece of equipment can ripple outward in ways that were not apparent when the project scope was first defined. In some cases, the cost of accommodating the equipment may approach the cost of building new space altogether. A thorough understanding of all those ramifications of introducing new equipment is essential.
The same applies to buffer ring capacity. When a new product requires larger buffer volumes, the team may need to add or resize buffer hold tanks and the piping that connects them. This is not a plug-and-play modification. It affects scheduling, cleaning validation, and the ability to run existing products simultaneously.
Harvest filter flexibility is another area to evaluate carefully. Some processes work best with filters in series, others in parallel. Some require filters to operate independently of the downstream harvest vessel. The existing facility may be set up for one approach, while the new product may require another. Designing for flexibility upfront is almost always less expensive than retrofitting later, and that tradeoff is worth quantifying during feasibility.
Keeping the current product running
This is the one factor that can make NPI programs genuinely difficult. Clients cannot afford simply to pause manufacturing of existing products. Revenue and patient supply depend on continued production. So the new product has to be introduced in the spaces between.
That means construction and commissioning activities have to fit within defined shutdown windows. Those windows are typically short, often during scheduled maintenance periods or planned equipment downtime. If modification requires a longer shutdown than the window can accommodate, the team has a problem. Either the scope has to be broken into smaller phases, each of which fits within an available window, or the schedule has to accommodate an unplanned production gap.
Spot construction in an operational facility looks different from greenfield or full-facility renovation work. Crews can’t just operate freely throughout the building. Contamination controls have to be maintained. Material deliveries have to be coordinated around production schedules. Noise and vibration from construction activities can affect sensitive processes nearby. The consequences of a mistake may cause schedule delays, or worse yet product quality and regulatory compliance.
A project management strategy has to account for all of this from the beginning. That means close coordination with Manufacturing Science and Technology (MSAT) teams, manufacturing operations, site engineering, and the construction team. None of these groups can work on their own, without coordination. The schedule is a shared document, and any possible shutdown windows are largely non-negotiable. The earlier everyone is aligned on both, the fewer surprises there may be down the road.
Automation: Recipes, validation and the risk of interference
Modern biopharmaceutical manufacturing relies heavily on automated control systems. Process steps are encoded as “recipes” in the facility's distributed control system (DCS) or manufacturing execution system (MES). When a new product is introduced, new recipes have to be written, tested, and validated alongside existing ones.
That work takes time, and it has to happen in a live system that is already running validated recipes for existing products. A configuration error in a new recipe that touches shared equipment or shared utilities can affect existing processes. Validation activities for the new product require equipment time that may compete directly with production schedules.
One of the most frequently underestimated aspects of NPI planning is automation scope. Writing a new recipe, unfortunately, is not always a straightforward software job. It requires detailed process knowledge, careful mapping of equipment and interlocks, coordination with the controls vendor, and thorough testing before the recipe is used in a current Good Manufacturing Practice (cGMP) context. That can be a massive undertaking, and it has to be scoped and resourced correctly from the start, not added on once the physical design is complete.
Scope management: The most common source of overrun
In NPI programs, scope creep can be common, and often for understandable reasons. For example, someone on the team may need (rightly) to include future flexibility. But there’s a cascading effect in these kinds of decisions. A small modification that solves an immediate problem can open up a conversation about a larger upgrade. The client may see an opportunity to address an existing facility limitation once the contractors are already on site.
None of these conversations are inherently wrong. Future flexibility is genuinely valuable. Addressing existing limitations can still be cost-effective even when work is already underway. But each addition to scope has cost and scheduling implications, which compound complexity. An addition that looks manageable on its own may be the fifth addition to a project that was already running lean.
Scope management in NPI programs requires a clear line between what the project must deliver and what it would be nice to deliver. The engineering team has a responsibility to make it clear when scope additions could create design complexity that might put the core program at risk. Clients have a responsibility to make those tradeoffs explicitly, with full cost and schedule visibility, rather than letting scope drift through informal decisions.
Budget and schedule overruns in NPI programs rarely come from a single large decision but from accumulated small ones. Each addition seemed manageable at the time. Together, they push the program beyond what the original plan could support. The feasibility study, done well and honored throughout the project, is the best defense against that pattern.
Front-end work pays off
The common theme across all of this is that the challenges of new product introductions are more manageable when they are addressed early. A feasibility study that catches a sizing problem before design begins is far less expensive than a redesign after drawings have been done. A tech transfer review that identifies filtration technology or other constraints upfront gives the team time to evaluate alternatives. Automation scope that is fully understood at the start does not turn into possibly costly problems once the project is under way.
NPI programs are complicated. The existing facility, the existing product, the regulatory environment, and the new process requirements all have to be reconciled simultaneously. There is no way to eliminate that complexity. But there are ways to manage it. Bringing the right technical expertise into the program early, doing the front-end work thoroughly, and maintaining discipline on scope are the best tools available to any project team.
For engineers and project managers, early analysis, honest feasibility assessment, and cross-functional coordination (with full stakeholder buy-in) are the best returns on investment in any project budget. It reduces risk and shortens the path to a workable design. And, most importantly, it keeps the existing product running while the new one gets off the ground.
About the author
Shwetha Ravi Devine is a Lead Process Engineer at Arcadis with experience in biopharmaceutical facility design and new product introduction programs. Her recent project work includes NPI engineering support for major biopharma clients across upstream, downstream, and facility modification scopes.