HPAPIS Production: "Where Micrograms Matters"

High-potency drug manufacturing introduces a unique set of technical, operational, and strategic challenges — often without clear industry standards to rely on. In this session, high-potency expert Lydia Garcia‑Martin draws on nearly two decades of experience in global pharmaceutical manufacturing to break down what it truly takes to move from planning into confident, compliant production.

The discussion goes beyond personal protective equipment to explore a layered containment approach that starts with strategy and design. Key topics include defining high-potency APIs, understanding OEL versus OEB, and applying risk-based thinking to equipment, facility design, workflows, and cleaning validation. Using practical examples from oral solid dosage manufacturing, Lydia illustrates how primary, secondary, and tertiary containment work together to reduce exposure risk while supporting efficiency and product quality.

Attendees will gain a clearer view of how to align safety, compliance, and cost from day one — whether preparing for a first high-potency project or refining an existing operation. The session concludes with insights into managing uncertainty, mitigating risk, and building robust processes that stand up across the product lifecycle.