Analytical Considerations for Low Dose DAI Studies

Dosage Administration Instructions are required prior to clinical dosing throughout a product lifecycle. Oftentimes, multi-specific antibodies as well as traditional antibodies are evaluated at dosing ranges (protein concentrations) significantly below the analytical capacity of product specific or platform established methods. This requires coordination between clinicians, formulators, and analytical groups. The material presented provides an overview of Pfizer’s analytical approach, describing a pre-verification workflow employed to rapidly identify alternative methods. In addition, there will be a discussion of alternative methods used in DAI studies and development considerations for these studies. Finally, a case study will be discussed in which these concepts were applied successfully.