Application of ICH Q9 Quality Risk Management Tools for Advanced Development of Hot Melt Coated Multiparticulate Systems.

This study aimed to apply quality risk management based on the The International Conference on Harmonisation guideline Q9 for the early development stage of hot melt coated multiparticulate systems for oral administration. N-acetylcysteine crystals were coated with a formulation composing tripalmitin and polysorbate 65. The critical quality attributes (CQAs) were initially prioritized using failure mode and effects analysis.

Monitoring of a Hot Melt Coating Process via a Novel Multipoint Near-Infrared Spectrometer.

The aim of the present work was to develop a PAT strategy for the supervision of hot melt coating processes. Optical fibers were placed at various positions in the process chamber of a fluid bed device. Experiments were performed to determine the most suitable position for in-line process monitoring, taking into account such requirements as a good signal to noise ratio, the mitigation of dead zones, the ability to monitor the product over the entire process, and reproducibility.

Use of mechanistic simulations as a quantitative risk-ranking tool within the quality by design framework.

The purpose of this study is to evaluate the use of computer simulations for generating quantitative knowledge as a basis for risk ranking and mechanistic process understanding, as required by ICH Q9 on quality risk management systems. In this specific publication, the main focus is the demonstration of a risk assessment workflow, including a computer simulation for the generation of mechanistic understanding of active tablet coating in a pan coater. Process parameter screening studies are statistically planned under consideration of impacts on a potentially critical quality attribute, i.

Monitoring mammalian cell cultivations for monoclonal antibody production using near-infrared spectroscopy.

Near-infrared (NIR) spectroscopy as a process monitoring and process supervision technique is reviewed in the context of biomanufacturing.An industrial pilot-plant mammalian cell cultivation process has been chosen to illustrate the use of on-line in-situ NIR monitoring by means of an immersion transflectance NIR probe.NIR calibration development must be performed carefully and should incorporate a number of steps to obtain a properly validated model which exhibits long-term robustness and is independent of process scale.