Continuous Manufacturing of Biologics Is Ready to Scale
Continuous manufacturing of biologics could cut facility costs by up to 50%. Learn what ICH Q13 and the latest evidence mean for pharma teams.
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.
Pharmacovigilance Trends Shaping Drug Safety Reporting in 2026
We explore the pharmacovigilance trends shaping drug safety in 2026, from AI and real-world data to ICH E2D(R1), to reporting quality for MedSafety Week 2026.
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.
SynthID Bio: Watermarking AI-Designed Proteins
SynthID Bio embeds hidden watermarks in AI-designed proteins. See how Google DeepMind’s tool could strengthen biosecurity and what pharma R&D should do next.
FDA Expedited IND Pilot Targets Faster First-In-Human Trials
The FDA’s Expedited IND Pilot introduces rolling review and sponsor-QRI partnerships to accelerate Phase I first-in-human trials while retaining regulatory oversight.