Media and buffer preparation is a key part of the biopharmaceutical manufacturing process. And although it doesn’t have to be carried out in sterile conditions, improving the powder transfer process makes this step cleaner, safer, and more efficient, protecting personnel while cutting time and costs as well. Read the full text of this application note in the PDF (Login required).
Tuesday, August 18, 2015 Daily Archives
Innovative Single-Use Clarification System for High-Density Cell Cultures
Continuous improvements in growth media and cell line viability have resulted in increased biomass concentrations in biopharmaceutical production processes, making the downstream purification step more challenging. Body feed filtration (BFF) has proven to be a successful method of solving similar issues in other industries (Figure 1). This robust technology is now available as a harvesting solution for biotechnology applications (1). Read the full text of this application note in the PDF (Login required).
Genderless Sterile Connectors: How They Increase Flexibility, Reduce Complexity, and Drive Toward Standardization
Historically, single-use connections involved a male and a female half. These were two distinctly different parts that mated with each other. Genderless connections — those in which the connector halves are identical in design — bring multiple benefits to modular single-use systems. Read the full text of this application note in the PDF (Login required).
Three-Step Monoclonal Antibody Purification Processes Using Modern Chromatography Media
This application note describes a monoclonal antibody (MAb) purification process using the expanded MAb purification toolbox of GE Healthcare’s Life Sciences business, covering modern chromatography media (resins) for standard and challenging purification tasks. The most established approach for purifying MAbs is a three-step process, where the initial capture step using a protein A medium is followed by two polishing steps using cation- exchange (CIEX) and anion-exchange (AIEX) media (Figure 1a). However, for more challenging MAb purifications, an expanded MAb purification…
Volume Reduction and Process Optimization with Cadenceâ„¢ Inline Concentrator
Pall’s patented single-pass tangential-flow filtration (TFF) technology simplifies current TFF processes (1). It eliminates the conventional TFF recirculation, allowing an efficient single-pass operation without mixing or foaming issues and exposes the product to low shear, which optimizes the processing of fragile and shear-sensitive molecules. The single-pass feed flow rates are lower than those of conventional TFF, minimizing the hold-up volume and maximizing product recovery. It allows for higher final concentrations because processing limitations due to minimum working volumes are optimized…
Adsorption Study of Egg-Derived Influenza Virus with Cellufine Sulfate Affinity Chromatography Media
An efficient process for purifying virus particles is important when developing a vaccine. Cellufine Sulfate affinity chromatography medium has been used for manufacturing viral vaccines such as influenza virus, rabies virus, and Japanese encephalitis virus. Here we describe how to purify egg-derived influenza with Cellufine Sulfate media. Figure 1 shows a typical chromatogram of inactivated influenza virus A strain (H7N7) from allantoic fluid with Cellufine Sulfate media. Table 1 shows that adsorbed virus particles are eluted from the medium easily…
Purification of Monoclonal Antibodies from CHO Cell Culture Supernatants Using KANEKA KanCapAâ„¢
Developing robust and scalable purification processes for monoclonal antibodies (mAbs) can save time and money. KANEKA’s protein A chromatography resin, KANEKA KanCapAâ„¢, offers the required high-performance characteristics to develop platform purification processes for mAbs: high binding capacity, high alkaline stability, good elution profiles, low nonspecific binding, and robustness in column packing. Here we provide purification data of five different mAbs (two humanized IgG1s, two humanized IgG2s, and a chimeric IgG1) using KANEKA KanCapAâ„¢. The Chinese hamster ovary (CHO) cell culture…
New LEWA EcoPrime LPLC/BID – Analytical Accuracy at Pilot and Production Scale
The new LEWA EcoPrime® LPLC chromatography platform combines proprietary fluid design and LEWA Intellidrive® technology to deliver unrivaled batch-to-batch reproducibility and accuracy. The new EcoPrime system features our open-architecture automation software and is built on a quality control of the industry’s most vertical supply chain. A single LEWA system has the range of up to three conventional LPLC units while providing higher accuracy. That gives users great flexibility, more floor space, and plant-friendly integration with simple software customization and updating.…
Monoclonal Antibody Production – Viral Clearance and Host-Cell Protein Reduction Using a High-Capacity, Single-Use, Strong Anion-Exchange Device
Strong anion-exchange (Q) chromatography is an industry standard for polishing purification steps of monoclonal antibody (MAb) production. It is a proven technology that removes viruses and host-cell proteins (HCP) from process feed streams in flow-through mode. NatriFlo HD-Q device adsorbers feature a hydrogel membrane, which combines high dynamic binding capacity and salt tolerance to deliver best-in-class performance. This makes it possible to rapidly process-large sample volumes using a small disposable device. This article examines the ability of NatriFlo HD-Q adsorbers…
Scaling Up a MAb Purification Process Using Continuous Chromatography
In batch-mode chromatography, operating conditions do not allow full use of a media’s total capacity, leading to a subutilization of the media (1, 2). Sequential multicolumn chromatography (SMCC) is an open-loop process for the separation of multicomponent mixture buffers (3, 4). The concept behind SMCC is to perform different steps in smaller columns (from two to eight columns, compared with batch chromatography) connected in series, to maximize media use without product loss. BioSC® Lab is an automated system based on…