Modeling the extra column volume of a micro simulated moving bed chromatography system: Introducing the equivalent radial flow rate distribution.

Recently, the focus in chromatography model development has expanded to include the modeling of extra column volume (ECV), particularly in small- and lab-scale systems where ECV can constitute a significant portion of the total volume. Typically, ECV is modeled with 1D approaches, for example with combinations of dispersed plug flow reactors (DPFRs) and continuously stirred tank reactors (CSTRs). However, radial inhomogeneities in the ECV concentration profile necessitate higher-dimensional models for more accurate predictions.

Micro simulated moving bed chromatography-mass spectrometry as a continuous on-line process analytical tool.

Continuous manufacturing is becoming increasingly important in the (bio-)pharmaceutical industry, as more product can be produced in less time and at lower costs. In this context, there is a need for powerful continuous analytical tools. Many established off-line analytical methods, such as mass spectrometry (MS), are hardly considered for process analytical technology (PAT) applications in biopharmaceutical processes, as they are limited to at-line analysis due to the required sample preparation and the associated complexity, although they would provide a suitable technique for the assessment of a wide range of quality attributes.

Development of a 3D printed micro simulated moving bed chromatography system.

In the 1960s, chromatography processes were revolutionized by the invention of simulated moving bed chromatography. This method not only enhances the separation performance and resin utilization in comparison to batch-chromatography, it has also a much lower buffer consumption. While simulated moving bed chromatography nowadays is applied for a wide range of industrial applications, it was never transferred to the micro-scale (in regards to column and system volume).

Configurable 3D Printed Microfluidic Multiport Valves with Axial Compression.

In the last decade, the fabrication of microfluidic chips was revolutionized by 3D printing. It is not only used for rapid prototyping of molds, but also for manufacturing of complex chips and even integrated active parts like pumps and valves, which are essential for many microfluidic applications. The manufacturing of multiport injection valves is of special interest for analytical microfluidic systems, as they can reduce the injection to detection dead volume and thus enhance the resolution and decrease the detection limit.

Multi-attribute PAT for UF/DF of Proteins-Monitoring Concentration, particle sizes, and Buffer Exchange.

Ultrafiltration/diafiltration (UF/DF) plays an important role in the manufacturing of biopharmaceuticals. Monitoring critical process parameters and quality attributes by process analytical technology (PAT) during those steps can facilitate process development and assure consistent quality in production processes. In this study, a lab-scale cross-flow filtration (CFF) device was equipped with a variable pathlength (VP) ultraviolet and visible (UV/Vis) spectrometer, a light scattering photometer, and a liquid density sensor (microLDS).

Automated Solid-Phase Protein Modification with Integrated Enzymatic Digest for Reaction Validation: Application of a Compartmented Microfluidic Reactor for Rapid Optimization and Analysis of Protein Biotinylation.

Protein modification by covalent coupling of small ligands or markers is an important prerequisite for the use of proteins in many applications. Well-known examples are the use of proteins with fluorescent markers in many experiments or the binding of biotinylated antibodies biotin-streptavidin coupling in the frame of numerous bioassays. Multiple protocols were established for the coupling of the respective molecules, e.