Whitepaper Cell Therapy: Regulatory & Supply Chain Considerations for Human AB Serum

GeminiBio, in collaboration with Compliance Insight, Inc., a nationally recognized compliance firm serving FDA-regulated industries, has released an essential white paper on human serum use in cell therapy development and manufacturing. This guide delivers expert insight on regulatory, supply chain, and supplier considerations — helping cell therapy developers de-risk development and accelerate timelines.

Why Serum Strategy Matters

Choosing the right human serum goes far beyond simple sourcing—it means strategically navigating global regulations, vetting suppliers, ensuring scalable supply chains, and maximizing cell performance. 

Key Topics Covered:

• Sourcing & supplier evaluation
• Regulatory alignment across regions
• Supply chain implications by serum type
• Balancing performance, scalability & compliance