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Needle clogging induces several issues during the filling step of injectable drugs, which makes essential to avoiding it to ensure a favorable outcome for the process. The suck-back function, present in peristaltic pumps, is often used empirically to that end. This study aims at describing and understanding the fluid behavior after suck-back application, which provides some quantitative specifications to prevent needle clogging. [ABSTRACT FROM AUTHOR]

Stirred media milling is the main technology for producing colloidal nanocrystalline suspensions. A number of studies have been reported on the effect of different operating parameters for lab, pilot, and industrial scales. However, typical milling tool box that can be used to support candidate from selection up to phase III clinical supplies can involve different mill configurations. This article describes a parametric study and milling kinetic modelling of the different mills. The impact of active pharmaceutical ingredient (API) type and process parameters on milling kinetics was determined. The milling kinetics were modeled using an empirical model which allows for predicting and simulation of milling kinetics of stirred annular and pin mills. The proposed model was found to accurately fit milling kinetics whatever the API considered, technology employed, and the process parameters used for milling. Moreover, the model was found to be able to ensure the process transfer from one mill to another. [ABSTRACT FROM AUTHOR]

The viscosity of high-concentration protein solutions can lead to a range of challenges in drug product manufacturing and administration. Accurately modeling the viscosity of biologics solutions in response to changes in the formulation and surrounding environment is of significant interest and remains a challenge. Here, we show a practical method of modeling the viscosity of a therapeutic solution in response to changes in temperature and protein concentration. Our viscosity model consists of a Ross-Minton model of concentration dependence and a modified Arrhenius temperature dependence. We measured the viscosity as a function of concentration and temperature of 4 therapeutic antibodies in a range of potential clinical formulations. With these data, our model shows surprising generality, proving effective with different types of antibodies, formulations, and a range of more than 2 orders of magnitude in viscosity. Our approach is built on existing theory but provides a practical approach to modeling the viscosity of formulated drug product over the range of process-relevant concentrations and temperatures to better mitigate challenges in the drug manufacturing process. [ABSTRACT FROM AUTHOR]