Influence of excipients in Protein A chromatography and virus inactivation.

The purification of monoclonal antibodies and Fc fusion proteins consist of several unit operations operated commonly as a platform approach, starting with Protein A chromatography. The first capture step, the following low pH virus inactivation, and subsequent ion exchange chromatography steps are mostly able to remove any impurities, like host cell proteins, aggregates, and viruses. The changes in pH and conductivity during these steps can lead to additional unwanted product species like aggregates.

Lyophilization Cycle Design for Dual Chamber Cartridges and a Method for Online Process Control: The "DCC LyoMate" Procedure.

Freeze-drying process design is a challenging task that necessitates a profound understanding of the complex interrelation among critical process parameters (e.g., shelf temperature and chamber pressure), heat transfer characteristics of the involved materials (e.

Evaluation of Different Holder Devices for Freeze-Drying in Dual-Chamber Cartridges With a Focus on Energy Transfer.

For freeze-drying in dual-chamber cartridges, a holder device to enable handling and safe positioning in the freeze-dryer is necessary. The aim of this study was to analyze 4 different types of holder devices and to define the best system based on energy transfer. The main criteria were drying homogeneity, ability to minimize the influence of atypical radiation on product temperatures, and heat transfer effectiveness.

Heat Transfer Analysis of an Optimized, Flexible Holder System for Freeze-Drying in Dual Chamber Cartridges Using Different State-of-the-Art PAT Tools.

The aim of this study was to determine the heat transfer characteristics of an optimized flexible holder device, using Tunable Diode Laser Absorption Spectroscopy, the Pressure Rise Test, and the gravimetric procedure. Two different controlled nucleation methods were tested, and an improved sublimation process, "preheated plate," was developed. Tunable Diode Laser Absorption Spectroscopy identified an initial sublimation burst phase.

Energy transfer during freeze-drying in dual-chamber cartridges.

Freeze-drying essentially requires knowledge about the heat and mass transfer characteristics to assure product quality. Whereas this understanding has been created for freeze-drying in vials, only limited information is available for state-of-the-art multiple compartment container systems such as dual-chamber cartridges (DCCs). Therefore, the aim of this study was to investigate the heat transfer characteristics of this novel container format.