Analytical Services: Risk Management In PFS Components Selection For Sensitive Biological Drug Formulations

By Claire Brunet, Filippo Conti, Pauline Romain, DCP Analytical Lab, BD Medical – Pharmaceutical Systems

Prefilled glass syringes have gained strong acceptance as delivery systems for injectable drugs and are now widely used for therapeutic biological formulations. Injectable biological drugs are extremely sensitive to their environment and handling conditions. The biologics sensitivity is often overlooked during the final primary packaging selection. The introduction of prefilled syringes components combined with a wide variety of stress occurring during the product shelf life can potentially trigger unexpected interface incompatibilities and drug chemical instabilities such as protein oxidation, aggregation and particles formation, affecting drug product integrity, device performances and product requirements (e.g. subvisible particles).^1,2,3,9

Choosing the right containers and materials is critical but also difficult¹⁰ and no methodology is available to quickly assess the risk of drug/device interaction. In this work, we provide differentiated capabilities and competencies in “Drug-Container Interactions Science” to support the design and life cycle of robust drug combination products in order to decrease the uncertainty and risk during development, support the understanding of the interaction phenomenon and the drug formulation.