A review of the regulatory requirements and guidance recommendations to support storage conditions of reconstituted and/or diluted drug products during IND development and for BLA approval will be presented. Microbial challenge study design and data analysis will be discussed. Case studies will be presented to illustrate how the microbial challenge data support the label instructions for storage conditions.
Antimicrobial effectiveness testing (AET) is used to confirm that preservative included in a formulation or diluent is effective at inhibiting growth of microorganisms, and AET is a requirement for multi-use drug products. This talk summarizes basic concepts of AET and discusses when testing is necessary. A case study is presented that highlights the need to understand AET variability and its relationship to preservative concentration during early development of a multi-dose program.
*Speaker Lutz Asmus has not allowed the sharing of slides or the archived recording.
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.