In advanced therapy manufacturing, every minute matters. Cell and gene therapies are patient-specific or highly specialized, and delays anywhere in the process can impact both regulatory timelines and patient outcomes. Yet as programs scale from early clinical runs to global commercial supply, manufacturers often discover that bottlenecks aren’t just about bioreactors and clean rooms – they’re hidden in documentation, quality control, tech transfer, and training. The ability to standardize processes becomes the linchpin for operational efficiency.
This webinar will explore four operational challenges that can lead to bottlenecks, compliance issues, and delivery delays:
- Comparability and multi-site tech transfer.
- End-to-end operations.
- Workforce enablement and knowledge capture.
- Asset reliability & validated state.
Drawing on recent regulatory updates, industry benchmarks, and case examples, we’ll outline practical, scalable steps manufacturers can take – whether you’re running your first clinical batches or operating at full commercial scale.
Key Takeaways
- Learn practical, stage-appropriate steps to improve process efficiency, from early clinical runs to global commercial supply.
- See how digital systems can work in concert to harmonize data, streamline QA/QC, and enable faster tech transfer.
- Review real-world metrics from leading cell therapy manufacturers, including how one pioneer achieved a 50% reduction in review times while maintaining 99% right-first-time manufacturing.
- Discover how regulatory expectations impact manufacturing comparability, release testing, and validated state management.
Gain strategies for sustainable growth that balance hardware investments with a scalable digital foundation to deliver therapies faster and more reliably.
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