Changing Manufacturing Processes to Improve Consistency of Radiopharmaceutical Drug Products & Improve Quality Readouts

• Understanding challenges associated with intermediates characterization, particularly those driven by short half-lives
• Navigating regulatory challenges associated with changes in manufacturing processes, including demonstrating comparability and justifying revised control strategies to regulators
• Cost/benefit analysis of improved processes, balancing upfront investment against improved batch consistency, reduced deviations, and more reliable quality readouts

Speakers:

Jose Zayas

Quality Assurance, Regulatory Affairs Radiopharmaceuticals/Chemistry, Manufacturing & Controls Consultant

Zaycor Industries Corp.