GxP Insights: Decentralized Manufacturing: The Next Big Shift in Cell & Gene Therapy?

Welcome to our monthly industry insights newsletter, tailored for professionals in Medical Devices, Biologics, Cell & Gene Therapy, and Sterile/Aseptic Manufacturing. Each edition delves into a key industry theme, offering expert perspectives and career insights to help you stay ahead.

This month, we explore how decentralized, near-patient manufacturing could reshape speed, access and scalability in Cell & Gene Therapy, and what this emerging model might mean for the future of CGT production.

Centralized vs. Decentralized Manufacturing in Cell & Gene Therapy (and why it matters)

Cell & Gene Therapy (CGT) has traditionally relied on large, centralized facilities handling every step of production, testing and release. While this model provides strong process control and mature quality oversight, it also creates inherent constraints, particularly for autologous therapies, where each hour in transit can affect viability and patient outcomes.

Despite major scientific and regulatory progress across the CGT field, patient access remains well below expectations. High manufacturing costs, limited global capacity and the difficulty of scaling personalized processes all contribute, but the core challenge persists: producing these therapies efficiently, consistently and at the scale required.

These pressures are driving renewed interest in decentralized or near-patient manufacturing, supported by advances in automation, closed-system technologies and modular GMP infrastructure. The concept is straightforward: bring manufacturing closer to patients to shorten turnaround times, reduce logistical risk and expand access.

As the conversation evolves, organizations are assessing where decentralized models genuinely add value, and where centralized manufacturing will remain essential. The reality is not binary: the right approach depends on product characteristics, process maturity, required throughput and the balance between flexibility, cost and control.

The Enablers: Technology & Regulation

With demand exceeding capacity, vein-to-vein timelines tightening, and scale-up challenges unresolved, the industry is increasingly exploring decentralized manufacturing. So what’s enabling this shift?

• Technology has reached a turning point: automation, closed-system processing, digital batch records, chain-of-custody tools and modular cleanrooms now make multi-site operations technically feasible.
• Regulation is starting to adapt, led by the UK MHRA’s 2025 guidance suite outlining expectations for digital traceability, local batch release, quality oversight and comparability across distributed sites - one of the first structured regulatory approaches globally.
• In the US, progress is earlier-stage: while FDA guidances address comparability and manufacturing changes (and distributed manufacturing is referenced in initiatives like FRAME), there is no dedicated framework for decentralized CGT manufacturing yet.
• As a result, US activity remains focused on pilots and feasibility studies as regulators, clinicians and manufacturers refine expectations for process control, oversight and quality release across multiple sites.

The Human Factor: Why Talent will determine Decentralized Manufacturing Success

Decentralized manufacturing brings meaningful operational challenges: maintaining consistent quality across multiple sites, managing higher costs driven by personalized processes and specialized materials, and ensuring strong oversight as organizations shift away from traditional, centralized control models.

These pressures create a parallel talent challenge. Multi-site networks require a larger, more consistently trained workforce with digital fluency, closed-system experience, and the ability to operate with less direct supervision. Today’s talent pool is not yet scaled to meet that demand, resulting in growing shortages across manufacturing, QA/QC, MSAT, and digital operations.

At the same time, this shift opens clear opportunities: decentralized networks generate new jobs, expand regional technical capability, and create fresh pathways for Life Sciences professionals across established hubs and emerging CGT clusters.

Innovation & Talent Hubs across the US East Coast

Across the US East Coast, several regions are emerging as key hubs for decentralized and advanced CGT:

• Boston and Cambridge continue to lead, supported by established CGT players and investments in automated, closed-system technologies.
• Philadelphia remains a global CGT powerhouse, well-positioned for hybrid and regionalized manufacturing models.
• Maryland’s Baltimore–Rockville corridor is becoming a major center for viral-vector production and CDMO expansion, driving demand for multi-site quality and operations talent.
• New Jersey is evolving toward more flexible, decentralized manufacturing, supported by its strong biopharma base.
• Emerging hubs, including the Research Triangle, South Florida and Upstate New York, are gaining traction through growing CGT research programs and early production investment.

Skills & Specialisms in Demand

As decentralized and near-patient manufacturing grows, demand is rising for manufacturing operators skilled in autologous and allogeneic workflows, alongside MSAT and Process Engineers experienced with closed-system and modular platforms.

QA/QC professionals with strong digital batch record, multi-site oversight and SOP governance capabilities are increasingly critical, as are automation and digital specialists across MES/EBR, IoT, PAT and chain-of-custody systems.

Regulatory and CMC experts with comparability, tech-transfer and decentralized manufacturing experience will be highly sought-after. Emerging opportunities are strongest across regional manufacturing scale-out, academic point-of-care facilities, expanded automation and digital oversight roles, and advanced vector, gene-editing and technical operations as organizations scale their CGT manufacturing networks.

Over to you

As manufacturing shifts closer to the patient, will the toughest challenge be scaling the specialist workforce required to run multi-site operations, or upskilling existing teams to meet the demands of decentralized GMP?

i-Pharm GxP

At i-Pharm GxP, we work alongside the Life Sciences organizations leading this evolution, helping them scope, staff, and deliver the GxP talent they need to succeed in a changing landscape.

If you’re exploring your next step, we’d love to connect.

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