In Cell and Gene Therapy, Momentum Is Everything.
Companies in early-stage R&D developing cell or gene-based therapies operate with urgency—racing toward clinical milestones, funding rounds, and market entry in a high-stakes space where a few have succeeded. But even the most promising programs can be slowed by bottlenecks in production, format flexibility, raw material readiness, or regulatory alignment.
Explore how to leverage adaptable systems and strategies designed to help you move faster, scale smarter, and reach your next milestone first.
Forward Momentum Against the Odds
From 14% to a Future With More
Snapshots of Success: Supporting the Unique Challenges of Early Stage
Explore quick snapshots of how innovative teams like yours are solving common challenges in early-stage cell and gene therapy development. From smarter scale-up strategies to simplified tech transfer, these real-world results showcase what’s possible when expertise and the right tools come together. Whether you're optimizing your upstream process or planning for clinical readiness, each story offers takeaways to help you move forward with confidence.
In-house Biopharma | US
Challenge: Non-scalable, open process step to remove cell aggregates
Solution: Scalable, closed filtration transfer set
Key Result: Significant improvement in operational efficiency with closed filtration solution integrated with subsequent unit operation
BioRestorative Therapies | US
Challenge: Rapid mycoplasma testing for high-density cell therapy products before QC release
Solution: Optimized PCR workflow with streamlined DNA extraction and detection
Key Result: Validated method cuts testing time from weeks to hours, enabling faster, reliable product release without compromising safety
HEALIOS K.K. | Japan
Challenge: Visualizing NK cell movement during cancer therapy research
Solution: Incucyte® SX5 Live-Cell Analysis System for high-throughput, cost-effective imaging
Key Result: Automated long-term imaging with parallel data analysis boosted efficiency and significantly reduced time and cost
There’s More to the Story When You Dive into the Data
Investing in Future-Ready Technologies
Facilities Designed for Early-Stage Success
Marlborough, Massachusetts is the home of Sartorius’ new center for innovation. Designed to foster collaboration, co-development and learning on site with customers and other external innovation partners, this facility applies Sartorius' latest technologies in real-life bioprocess workflows.
Watch our video tour to see how we’re enabling early-stage cell and gene developers to break new ground with practical, future-ready technologies.
- Automated Cell Therapy Platform (01:34)
- LNP Generation Tools (03:56)
- Process Development & Clinical GMP Services (07:25)
René Fáber
This cutting-edge innovation center enables us to leverage our bioprocessing tools and workflows expertise, ultimately accelerating and simplifying our customers’ path to clinical trials.
Reaching the Finish Line in Early-Stage Development
Building Better, Faster: Lessons from a Collaborative Development Journey
In early-stage development, achieving key milestones often means embracing agile strategies, strong partnerships, and moving beyond traditional process development methods. A prime example is the collaboration between Matica Biotechnology and Sartorius, which combined modular technologies and shared expertise to rapidly build and scale an AAV8 production platform. This effort was grounded in a “modular mindset” approaching each unit operation as part of a flexible, end-to-end system. Applying Quality by Design (QbD) principles in early-stage development sets the stage for successful scale-up, moving developers one step closer to regulatory approval.
Discover how this model broke barriers to success in three critical ways:
- Responding to market pressures for faster development, greater consistency, and GMP compliance.
- Adopting a modular mindset enabling plug-and-play development.
- GMP readiness by design – building in the expectations of regulatory agencies from the start.
- Accelerating timelines with important time-saving strategies like design-of-experiment (DoE) modeling.
Learn More
Request Your Sample | Raw Materials and Consumables
To help find the right materials and consumables for your needs, request a sample from our portfolio.
