How Should Pharma Companies Audit AI Vendors?
“This is one of the riskiest industries there is because you're dealing with human lives, you're dealing with experimental protocols, and you're dealing with regulatory bodies where you might not get another shot at that clinical trial."
The EU Biotech Act Puts Medical AI Safeguards at a Crossroads
The EU Biotech Act aims to accelerate biotechnology development. Explore how proposed medical AI reforms could affect patient safety, compliance, and pharma competitiveness.
Co-ordinated EU GMP Inspection Guidelines: What You Need to Know
New EU GMP inspection guidelines take effect in September 2026. Here is what you need to know about joint inspections, planning, and reporting.
More Than Conjugation: ADC Manufacturing
ADC manufacturing is becoming more complex as payloads, conjugation, lyophilisation, containment, and scale-up reshape CMC strategy and commercial readiness.
Inside the GMP Inspection Process, Explained
We map the GMP inspection process end to end, showing what regulators check, who is responsible, and where compliance often breaks down.
AI Bioweapons Risk Grows as Agent Safeguards Fail
The AI bioweapons risk has entered a new, more worrying phase as Moonshot AI’s Kimi’s jailbreak exposes gaps in agent safeguards.