Four Trends Shaping GMP Manufacturing: Takeaways from the ISPE-CaSA Tech Show Contributed by: Chris Smith, Director, Business Development

Last week, the ISPE-CaSA Tech Show continued its reign as the premier cGMP-focused life science conference in the Southeast. With nearly 4,000 registrations — a 20% increase from 2025 — the influence of the CaSA Chapter continues to grow.

Held on the main show floor at the Raleigh Convention Center, the conference draws GMP manufacturing and supporting organizations from across the Southeast and beyond. Although the CaSA Chapter officially represents North Carolina, South Carolina, Georgia, Florida, Alabama, and Tennessee, there is growing interest from organizations based in the Northeast and on the West Coast. North Carolina remains a primary player in GMP manufacturing, and investment in the state continues to rise. This year’s conference brought four key trends in GMP manufacturing into sharp focus.

1). AI is on everyone’s mind — but so is trust.

Everyone wants to know how to use AI more effectively. In a world where every input, every piece of equipment, and every decision is scrutinized by the FDA, how can organizations trust data if its accuracy cannot be fully verified? The conversation has moved beyond curiosity — the industry is now grappling with how to validate, govern, and integrate AI tools within a compliance-driven environment.

2). An aging workforce is straining an already stretched talent pipeline.

With over $15 billion in proposed projects announced in the past three years, the question is no longer whether North Carolina can attract investment — it’s whether the workforce can keep pace. A 25% shortage of qualified talent already existed before 2024, when more than $10 billion in additional projects were announced in the state alone. With an aging skilled trades workforce, the urgency to leverage academic partnerships and cross-train viable candidates has never been greater.

Compounding this challenge is a widening skills gap between employees with a few years of experience and those with 15 or more years in the field. As opportunities encourage young professionals to move quickly from role to role, the deep institutional knowledge that comes from spending extended time in a single position is increasingly hard to find. Companies don’t just need broad, high-level familiarity with GMP principles — they need technical depth. The shifting career landscape appears to be creating meaningful knowledge gaps in exactly the roles where expertise matters most.

3). Risk-based approaches, operational readiness, and supply chain integrity are top of mind.

Everyone is being asked to do more with less. Timelines are tightening, and teams are moving at a breakneck pace to design and build new facilities. To meet these demands, organizations must trust their partner organizations not only to act in their best interest, but also to strategize creatively and execute quickly.

Upfront planning is critical — identifying risk-based approaches across all project phases, including design, engineering, construction, and qualification, must happen as early as possible. Systems supporting operational readiness and a clear path to green-lit manufacturing need to be in place well before they’re urgently needed. Since most manufacturing organizations are primarily focused on developing and producing medicines, facility builds require close collaboration with partners that many employees rarely engage with over the course of their careers. As a result, a collection-of-experts model is becoming increasingly essential for facility building and supply chain support. Although the industry survived the post-covid global delays on equipment manufacturing, the pandemic highlighted the inherent risks of functioning without a robust supply chain.  Derisking using multiple vendors, having backup systems in place, and knowing how to pivot in case of unexpected situations is now the expectation.

4). Regulatory evolution and data integrity are reshaping how organizations approach compliance.

The regulatory landscape is shifting, and manufacturers are feeling it. The FDA’s continued modernization efforts — including the industry-wide transition from Computer Software Validation (CSV) to Computer Software Assurance (CSA) — are prompting organizations to fundamentally rethink how they approach software lifecycle management and documentation. The emphasis is moving away from exhaustive prescriptive testing toward a more risk-based, outcomes-focused assurance model. For many organizations, this requires not just updated procedures, but a genuine cultural shift in how compliance teams think and operate.

At the same time, data integrity remains a persistent focal point for regulators. As electronic records, automated systems, and digital workflows become the norm across manufacturing environments, the expectations around audit trails, access controls, and data governance have never been higher. Organizations that are still relying on hybrid paper-based systems or poorly validated software face growing exposure. The message from the industry is clear: investing in robust, compliant data infrastructure is no longer optional — it is foundational to sustainable manufacturing operations.

Looking Ahead

The ISPE-CaSA Tech Show once again proved that the Southeast is not just keeping pace with the broader life sciences industry — it is helping to define it. From the promise and complexity of AI adoption to workforce development, to operational readiness and regulatory evolution, the challenges facing GMP manufacturers are significant. But so is the collective expertise in the room. What stood out most was not any single trend, but the spirit of collaboration and problem-solving that characterized every conversation on the show floor. As North Carolina and the broader region continue to attract investment and build out manufacturing capacity, conferences like this one serve as an essential forum for sharing knowledge, building partnerships, and moving the industry forward together.