How do you validate cleaning processes for ADCs, monoclonal antibodies (mAbs), and highly potent active pharmaceutical ingredients (HPAPIs)? What role do degradation studies, cleaning-agent selection, and analytical testing play in reducing validation risk and supporting regulatory expectations?
The ISPE Foundation Professional Development Grant program is designed to help students and recent graduates accelerate their professional growth by participating in premier industry events. Through financial support to attend ISPE conferences, the program provides emerging professionals with opportunities to learn from industry experts, explore the latest trends shaping pharmaceutical...
Driven by a passion for science, problem-solving, and improving patient outcomes, Keira Mull is building a career in pharmaceutical manufacturing centered on continuous improvement and service. As a Senior Manufacturing Specialist at AstraZeneca and an active volunteer with ISPE's Chesapeake Bay Area Chapter, she is committed to operational excellence, mentorship, and professional...
FUJIFILM Biotechnologies’ Galaxy project is redefining how large-scale biopharmaceutical manufacturing facilities are designed, built, and deployed. Recognized with an Honorable Mention in the 2026 ISPE Facility of the Year Awards (FOYA), the facility exemplifies how digital replication, modular construction, and Pharma 4.0™ technologies can accelerate the delivery of critical manufacturing...
