3d rendering of Human cell or Embryonic stem cell microscope background.
At Compliance Insight, we’re always proud to see our leadership shaping the future of regulated industries—and this time, it’s our very own VP, Troy Fugate, who’s making waves.
In partnership with GeminiBio, Troy has contributed to a newly released white paper that dives deep into a critical (and often overlooked) piece of the cell therapy puzzle: the regulatory and supply chain risks of using human serum in CAR-T and other advanced therapies.
As the field of cell and gene therapy accelerates, so does the complexity of its regulatory landscape. This white paper provides practical, experience-backed guidance for developers navigating the challenges of sourcing and qualifying human-derived materials. From GMP compliance to risk mitigation strategies, it’s a must-read for any team focused on building a resilient, regulatory-ready pipeline.
🔬 White Paper Title:
Human Serum – Regulatory and Supply Chain Risk Mitigation for Cell Therapy Developers
📄 Download your copy here: Regulatory & Supply Chain Considerations for Human AB Serum
Kudos to GeminiBio for spotlighting such a critical topic—and to Troy for continuing to bring clarity and compliance to cutting-edge science.