GxP Insights: How Next-Generation Biomanufacturing Is Reshaping Biologics Production

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 examine how next-generation biomanufacturing is transforming the development, scaling, and delivery of biologic therapies, and what this shift means as the industry moves toward more flexible, resilient, and patient-centric production.

What is Next-Generation Biomanufacturing, and why does it matter

Next-generation biomanufacturing applies advanced technologies and modern production strategies to improve how biologics are developed and manufactured. Moving beyond traditional batch processes and fixed infrastructure, these approaches emphasize modular, digital, and scalable production models, enabling faster timelines, lower costs, and improved sustainability while remaining fully compliant with Good Manufacturing Practices (GMP) and regulatory standards.

Adoption is being driven by mounting pressure on legacy manufacturing systems to support a rapidly evolving biologics landscape. Key drivers include:

• Rising biologics demand, particularly in oncology, immunology, and rare diseases, as monoclonal antibodies, vaccines, gene therapies, and cell-based treatments expand global pipelines.
  
  
• Growth of personalized medicine, with advanced therapies such as CAR-T cells, mRNA vaccines, and gene therapies requiring flexible, small-batch manufacturing and rapid turnaround.
  
  
• Increasing product and process complexity, driving higher demands on scalability, consistency, and process control.
  
  
• Supply-chain resilience and decentralization, following disruptions exposed during the COVID-19 pandemic.
  
  
• Regulatory support for innovation, with agencies such as the FDA and EMA encouraging modern manufacturing approaches that accelerate development while maintaining compliance.
  
  
• Pressure for cost-efficient, accelerated production, pushing organizations toward scalable, capital-efficient platforms that support faster scale-up.

Together, these forces are accelerating the adoption of next-generation biomanufacturing, delivering greater agility, cost efficiency, scalability, quality, compliance assurance, and sustainability, while enabling more on-demand, patient-specific therapies produced closer to the point of care.

So, what innovations are enabling this shift in practice?

Key trends shaping advanced biomanufacturing

Next-generation biomanufacturing is enabled by a set of closely linked innovations that are reshaping how biologics are produced and scaled:

1. Continuous Manufacturing: manufacturers are increasingly moving beyond batch-based production toward continuous processes, improving productivity, reducing downtime, and enabling real-time quality monitoring. This approach is well-suited to high-demand biologics. For more on Continuous Manufacturing, check out this edition of GxP Insights.
   
   
2. Single-Use Systems: single-use technologies, such as disposable bioreactors, tubing, and connectors, eliminate cleaning validation and reduce contamination risk, enabling faster changeovers and more flexible, scalable operations, particularly in multi-product environments. These systems also support sustainability by reducing water and energy consumption.
   
   
3. Automation: automation minimizes human intervention and human error, helping ensure greater consistency and safety. Robotic systems and smart sensors are increasingly used for tasks such as material handling, sampling, and media preparation, reducing reliance on manual processes.
   
   
4. Data-Driven Optimisation: advanced analytics, including AI, machine learning, process analytical technology (PAT), and digital twins, are enabling real-time process insight, predictive decision-making, and continuous optimization, improving both operational performance and quality control.

Innovation Hubs

Next-generation biomanufacturing is already valued at over USD 26 billion and is projected to more than double over the next decade. North America leads adoption, supported by a strong biopharma presence, advanced manufacturing infrastructure, sustained R&D investment, and a highly skilled workforce.

This momentum is increasingly visible along the US East Coast, where large-scale investments are expanding domestic biologics and advanced therapy capacity:

North Carolina

Major investments include Genentech’s ~$2B expansion of its Holly Springs biomanufacturing facility, Johnson & Johnson’s new $2B biologics facility in Wilson (under construction) and a new 160,000+ sq ft biopharmaceutical site in Holly Springs, alongside Novartis’ new Durham manufacturing hub for biologics and sterile packaging and Regeneron Pharmaceuticals’s commitment to large-scale biologics capacity through Fujifilm’s Holly Springs facility.

Pennsylvania

Eli Lilly and Company recently announced a $3.5B injectable medicines facility in the Lehigh Valley as part of its broader domestic expansion of four US “mega-sites”. Johnson & Johnson has also announced a new next-generation cell therapy manufacturing facility in PA.

Maryland

AstraZeneca has committed $2B to expand its Frederick biologics facility, nearly doubling commercial capacity and enabling rare disease manufacturing, alongside a new cell therapy site in Rockville.

Massachusetts

Moderna plans to invest $140M+ to complete end-to-end mRNA manufacturing and add fill-finish capability in Norwood, while AbbVie has begun a $70M expansion of its biologics R&D and manufacturing presence in Worcester.

Challenges to overcome

Despite its potential, next-generation biomanufacturing faces several barriers to broad and consistent adoption:

• Technical complexity and integration, requiring sophisticated setup, specialized expertise, and integration of complex control systems that can slow deployment and complicate tech transfer.
  
  
• Regulatory uncertainty and validation requirements, particularly around continuous processing, multi-product facilities, data integrity, and GMP-compliant materials, which can extend approval timelines.
  
  
• High upfront investment: while next-generation platforms may reduce costs over time, the initial capital required for modular cleanrooms, automation, and digital infrastructure remains a barrier, especially for smaller companies and emerging markets.
  
  
• Workforce capability gaps, as demand rises for skills that are still limited across the industry.
  
  
• Data security and digital risk, driven by increased reliance on connected and real-time systems.
  
  

Realising next-generation biomanufacturing at scale will require regulatory clarity, skilled talent, investment, and collaboration across the industry.

Skills in demand

As advanced manufacturing platforms mature, demand is rising for professionals across:

• Process Development & MSAT
• Automation & Digital Manufacturing
• Validation & CQV
• Quality Assurance
• Regulatory & CMC

Looking ahead

Next-generation biomanufacturing is becoming a foundational element of modern biologics production as digital, automated, and decentralized models mature. While these advances offer greater flexibility, scalability, and resilience, they also introduce complexity across operating models, validation strategies, digital integration, and workforce capability.

Successfully translating innovation into reliable, compliant, and scalable production will depend on disciplined execution aligned with evolving GxP expectations. Organizations that move early will be better positioned to deliver advanced therapies to patients safely, reliably, and at scale.

i-Pharm GxP

At i-Pharm GxP, we work closely with life sciences organizations adopting advanced manufacturing models, supporting evolving needs across quality, validation, regulatory, and technical operations.

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

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