Continuous Manufacturing in Pharma: Strategy, Execution, and Real-World Impact

Continuous manufacturing (CM) goes beyond a technical upgrade—it signals a strategic shift in how pharmaceutical manufacturing is planned and delivered. During CDMO Live 2025 in Rotterdam, Ray Sison, Managing Partner at SCxCMC, led a roundtable unpacking the real-world challenges, opportunities, and implementation strategies shaping the future of Continuous Manufacturing (CM).

Defining the Problem: The First Step in the Roadmap

A consistent message emerged early in the session: successful adoption of Continuous Manufacturing starts with a clear definition of the problem it is meant to address.

Participants discussed how CM can support various goals—such as reducing cycle times, improving supply chain resilience, or accelerating product release—but noted that each objective demands a different technical and operational approach. Without clearly defined outcomes, implementation risks becoming disconnected from business priorities.

As one attendee put it, too many organisations adopt CM as a general solution, rather than tying it to a specific need. This echoed earlier remarks by Kevin Bittorf, Ph.D., who observed at a previous industry forum: “You first have to define the problem to be solved… Once you’ve justified the outcome, then it makes sense to bring in the tools that help you get there.”

Coordination, Not Just Continuity

The group also explored the difference between having a continuous process and having a well-coordinated one. A key analogy—raised more than once—compared CM to a musical performance. Each unit operation, from granulation to tableting, must stay in sync for the entire process to function reliably.

While real-time quality monitoring, reduced variability, and faster throughput are often cited as benefits, participants pointed out that these advantages only materialise when processes across formulation, validation, and supply chain are aligned. A continuous production line loses impact if warehousing, regulatory, or quality processes can’t keep pace.

This led to a broader point: technological readiness doesn’t guarantee operational readiness. Integration across departments and functions remains critical.

Stakeholder Alignment: Involvement from the Start

The conversation then turned to stakeholder involvement, particularly the importance of engaging both internal teams and external partners early in the planning process.

Several participants noted that while many CDMOs have invested in continuous manufacturing infrastructure, not all are equally prepared to manage the regulatory, quality, or analytical complexities that come with it. Experience with PAT, real-time release, and hybrid systems can vary widely, making due diligence a key step for sponsors.

There was also recognition that, in biologics especially, upstream intensification often gets ahead of downstream readiness. Early involvement from formulation scientists, regulatory leads, and commercial teams helps ensure the system as a whole is prepared for scale-up.

Hybrid Approaches: A Pragmatic Path Forward

Rather than pursuing full end-to-end implementation from the outset, many participants described hybrid models as a more feasible entry point. Examples shared included using continuous granulation with batch coating—an approach that provided measurable benefits without overhauling the entire system.

These partial strategies were seen as practical ways to reduce risk, manage validation in stages, and generate internal learning before expanding further. Several attendees mentioned that hybrid models helped build internal alignment and stakeholder confidence, especially when transitioning from pilot to commercial scale.

Sison noted that these strategies work best when planned early: “Whether it’s tableting, encapsulation, flow chemistry, or biologics, we begin developing the continuous manufacturing strategy well before pivotal data arrives. That way, when it’s time to launch, your regulatory plan and supply chain are already calibrated to support success.”

CM as an Organisational, Not Just Technical, Shift

A recurring theme throughout the discussion was the need to view CM not only as a change in production technology but as part of a broader organisational shift.

Participants observed that companies that succeed with CM often do so by integrating it into their long-term business and manufacturing strategies, rather than treating it as a standalone project. This includes transitioning from reactive issue management to proactive process design and from transactional outsourcing to strategic CDMO partnerships.

CM implementation, in this sense, becomes a reflection of how well different parts of the organisation—R&D, regulatory, supply chain, and external partners—can align around shared goals.

Conclusion

The roundtable made it clear that continuous manufacturing offers meaningful benefits, but only when supported by thoughtful planning, cross-functional coordination, and practical execution strategies.

It is not necessarily about replacing everything at once or chasing the latest technologies. Instead, progress comes from clearly defining objectives, engaging stakeholders early, exploring hybrid pathways, and treating CM as part of a broader operational model.

The success of CM lies not in isolated advances, but in how effectively all components work together—like instruments in a coordinated performance. When aligned, the outcome is not just improved efficiency, but a more responsive and resilient manufacturing system fit for the future of pharmaceutical development.

Download the full 50 page CDMO Live 2025 report