As we see pipelines moving to progressively complex biologics—for example, antibody drug conjugates, bispecific antibodies, fusion proteins and other antibody derivatives—the question of a well designed drug product becomes even more pertinent.
Within the drug product field, pre-filled syringes and other combination products have been receiving increasing attention as the container closure system of choice for injectable drug products, where subcutaneous (SC) self-administration is preferred.
As an integrated approach for Biologics product development at the interface of formulation, primary packaging and application is required to ensure that the final QTPP (Quality Target Product Profile) is met, this presentation will showcase the impact of different protein and placebo formulations on particle formation and the functionality of pre-filled syringes, incl. a supporting case study.
Also, this presentation will highlight a focus on early clinical studies, in regards to the MABEL approach and associated challenges. There will be a second case study assessing the performance and compatibility of CSTDs (closed sterile transfer devices) with product formulation, as their usage has increased post issuing and effectiveness of the USP 800 monograph.
Head of Pharmaceutical Development in Drug Product Services