Roundtable Discussion: Bridging Across Analytical Methods for Therapeutic Proteins and Novel Modalities

Analytical methods continue to evolve rapidly to meet the evolving needs of new therapeutic modalities. Emerging analytical platforms often utilize different measurement principles, making direct comparison difficult and leading to lack of concordance. Bridging between methods requires comparative studies and a well characterized reference material or control. This talk will outline considerations for design and analysis of such studies using case studies from the mAb and AAV gene therapy fields

Presented by Dr. Anthony Blaszczyk, Principal Scientist in the Global Biologics Department at U.S. Pharmacopeia

Dr. Anthony Blaszczyk is a Principal Scientist in the Global Biologics Department at U.S. Pharmacopeia (USP), where he leads initiatives within the Pipeline Development group to advance standards for Cell and Gene Therapy (CGT). His work focuses on the development of both documentary and physical standards that support product quality and innovation. He plays a pivotal role in USP’s efforts to meet evolving industry needs through collaboration with scientific experts and stakeholders across the biopharmaceutical sector. Prior to joining USP, Anthony earned his Ph.D. in Biochemistry from Penn State University. He previously managed an Analytical Development team at Catalent’s Gaithersburg and Rockville sites, where he specialized in method development, qualification, and method transfer to support AAV-based gene therapy production.