Short-life advanced therapy medicinal products (ATMPs) create a fundamental challenge: how do you assure sterility for a product that may reach a patient within hours of release?

Existing health authority and compendial guidance often doesn't fully account for newer product types and processes, leaving developers to interpret, adapt, and build tailored contamination control strategies to fill the gaps. When the standard 14-day compendial sterility test isn't appropriate, teams must turn to rapid microbiological methods and alternative release procedures.

Irving Ford, VP & Head of Quality and Compliance at Made Scientific, recently joined a virtual roundtable of industry leaders, hosted by BioPharma Webinars. With more than 30 years in pharmaceutical quality and four cell therapy products taken from clinical to commercial, Irving's perspective is clear: sterility assurance must be engineered into the process, not inspected in after the fact.

In this on-demand session, attendees will explore:

• Rapid and alternative microbiological testing methods

• Identifying the right process steps for testing

• Sample sizing, validation, and storage

• Navigating regulatory challenges

• Aligning testing strategy with a broader Contamination Control Strategy

Source: the BioPharma Webinars roundtable "Sterility Testing Challenges and Opportunities for ATMPs" (May 2026), featuring Irving Ford alongside quality and microbiology leaders from Novartis, Roche, AstraZeneca, and others.