(522c) CQA Control Strategy for a Synthetic Peptide Therapeutic Candidate Etelcalcetide

Application of innovative continuous improvement strategies to ensure consistency and robustness of pharmaceutical drug substance (DS) manufacturing processes can add significant value over a productâ??s lifecycle. A case study from etelcalcetide, a synthetic peptide therapeutic candidate, will be presented highlighting Amgenâ??s modality-independent approach to process design. Application of QbD and QRM principles were fundamental in establishing a solid understanding of the impact of variability on DS critical quality attributes (CQAs) and overall process performance. Holistic frameworks to proactively identify, assess, and mitigate CMC risks was leveraged during the process design phase. Examples of specific DS CQAs will be used to show how establishment of appropriate controls required a combination of material input controls, procedural controls, in-process testing, and release testing.