Innovation meets reality: navigating the challenges of next-generation therapies
Cell and gene therapies are transforming modern medicineâoffering curative potential for diseases once considered untreatable. Yet despite remarkable progress, the journey from discovery to large-scale treatment remains complex.
In the new Sartorius e-Book âOvercoming Barriers in Cell and Gene Therapy,â seven leading experts from across the industry share their perspectives on how to bridge the gap between research, clinical translation, and commercial success. Their insights shed light on the core challenges of reproducibility, scalability, and complianceâand how innovation can overcome them.
1. Tackling variability and cost barriers
High development costs and biological variability continue to limit accessibility. Experts highlight how standardizing upstream and downstream processes is key to reliable outcomes.
âStreamlining is crucial for entering clinical trials and proving efficacy,â notes Josh Sonico, Platform Development Specialist for Cells and Extracellular Vesicles at Sartorius.
With geometrically consistent bioreactor technologies, Sartorius aims to simplify scale-up and reduce risk at every stage of production.
2. Building reproducibility through precision
Reproducibility is the foundation of every therapyâs success. The e-Book explores how precise instrumentation, consistent materials, and data-driven process control enable scientists to generate reliable, validated results ready for regulatory approval.
These insights emphasize how advanced analytics and automation can close the gap between early R&D variability and commercial-grade reproducibility.
3. From lab to market: achieving true scalability
Transitioning from small-scale development to full manufacturing remains one of the greatest bottlenecks in the field.
Through aseptic harvesting techniques and digital twin technologies, manufacturers can accelerate process transfer and streamline decision-makingâensuring that promising therapies reach patients faster and more efficiently.
âThe primary questions now revolve around reducing costs and making these therapies more accessible,â says Randall Alfano, Segment Technology Manager for Cell Therapy at Sartorius.
4. Ensuring compliance through technology
Compliance doesnât just protect patientsâit sustains innovation. The experts detail how integrated digital solutions can guarantee data integrity, validation, and traceability throughout therapy development.
From audit-ready documentation to smart process tracking, these solutions reduce regulatory friction and improve confidence in product quality.
Explore the complete expert e-Book
The Sartorius e-Book offers a consolidated view of strategies shaping the future of advanced therapies. Inside, youâll find interviews, case insights, and forward-looking solutions for every stage of developmentâfrom discovery to commercial production.
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Redefining whatâs possible in advanced therapies
From bioreactors engineered for seamless scale-up to data systems ensuring transparency and trust, Sartorius continues to drive the next chapter in cell and gene therapy innovation.
Together, the industry is moving toward a future where precision, accessibility, and compliance coexistâturning todayâs experimental promise into tomorrowâs reality.