BPS 2024
Applications of experimental design in process validation of peptide manufacturing processes
Hanna Radzey
Team Leader, Almac Group
ABSTRACT
The increased interest in peptides as drug candidates over the past decades due to improvements in manufacturing and their high potency, specificity, and functional diversity have led to a gradual increase in peptide drug approvals and an increased number of peptide drugs in clinical development. Due to the high variability in complexity of peptides entering the process validation stage, a specific approach is required for each candidate. Drawing from Almac’s expertise in process validation of small molecule drug candidates, an approach towards peptide process validation applying experimental design will be discussed.
BIO
Hanna Radzey, PhD, has the responsibility for a process development team of large molecules at Almac, including peptides, peptide conjugates and imaging agents. She has worked in the pharmaceutical industry as a process development chemist since 2016. She studied at the Bielefeld University and proceeded to do her doctoral and postdoctoral degree with a focus on peptide chemistry at the University of Göttingen and University of Glasgow.