Level: Beginner
Stephanie Lemoult, Senior Principal Scientist, Lonza AG
Introduction:
Product development for biologics requires pharmaceutical development in sync with clinical development. Maintenance of the quality, efficacy and safety of the product administrated to the patient is key. In use stability and simulated clinical administration studies are performed to generate experimental data, which support viable and safe administration procedures for medical products in clinic.
Challenges, Variables and CQAs: The goal for early phase formulation development of biologics relies on long term stability, flexibility of dosing (low , intermediate and high doses), use of common diluents and materials compatibility.
Designing the experiments for the case study:
To identify the best set up for the simulated administration study, multiple experiment have been performed and physical chemicals attributes have been analysed. The case study includes visualization of the results with JMP 15.
Conclusion: Compatibility of the formulation with two materials have been demonstrated with the recommended diluents and components.
The incubation in the dosing syringe for 4 hours at ambient conditions is supported by physico-chemical analytical data. The use of 0.22 um in line filter is strongly recommended supported by the subvisible particle data
