Low-Volume Aseptic Filling Using a Linear Peristaltic Pump.

The pharmaceutical industry has been confronted with new and complex challenges, particularly with regard to the aseptic filling of parenterals, including monoclonal antibodies and ophthalmologic drugs designed for intravitreal injections, which often require fill volumes <200 µL. In addition to intravitreal administration, microliter doses may be required for applications using highly concentrated formulations and cell and gene therapies. Many of these therapies have either a narrow or unknown therapeutic window, requiring a high degree of accuracy and precision for the filling system.

Assessment of Sensor Concepts for 100% In-Process Control of Low-Volume Aseptic Fill-Finish Processes.

The pharmaceutical industry is currently being confronted with new and complex challenges regarding the aseptic filling of parenterals, especially monoclonal antibodies, particularly for fill volumes <200 µL, which have become increasingly important with the increasing and continued development of intravitreal drugs and highly concentrated formulations. Not only does low-volume filling pose challenges to aseptic manufacturing, but the development of suitable in-process control to ensure reliable and robust filling processes for low-volume conditions has also been difficult. In particular, fill volumes <200 µL exceed limits of accuracy and robustness for the well-established method of gravimetric fill-volume control.

Low volume aseptic filling: Impact of pump systems on shear stress.

Low volume aseptic filling of parenterals, particularly monoclonal antibodies is becoming increasingly important with the development of more and more intravitreal drugs and high concentrated formulations. Especially monoclonal antibodies are very delicate products to fill and the use of the right fill finish equipment plays an important role during process development. Protein aggregation can occur under conditions described in literature and can be influenced by the fill finish processing.

A Method To Determine the Kinetics of Solute Mixing in Liquid/Liquid Formulation Dual-Chamber Syringes.

Unlabelled: Dual-chamber syringes were originally designed to separate a solid substance and its diluent. However, they can also be used to separate liquid formulations of two individual drug products, which cannot be co-formulated due to technical or regulatory issues. A liquid/liquid dual-chamber syringe can be designed to achieve homogenization and mixing of both solutions prior to administration, or it can be used to sequentially inject both solutions.