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Global BioPharma Product Testing Within Your Reach

As the largest international network of harmonized good manufacturing practice (GMP) product testing laboratories, Eurofins BioPharma Product Testing delivers a true local service experience. Eurofins BioPharma Product Testing offers the most complete range of testing services, harmonized quality systems, and laboratory information management systems (LIMS) to more than 2,000 pharmaceutical and biopharmaceutical companies worldwide. Read the full text of this application note in the PDF (Login required).

Cultivation of CHO Suspension Cells and SEAP Expression in the Finesse Glass Bioreactor

This application note describes the cultivation of Chinese hamster ovary (CHO) suspension cells in the Finesse SmartGlass vessel bioreactor with a maximum working volume of 2.0 L. Using chemically defined minimal media, cell densities of up to 7.44 Ă— 106 cells/mL were achieved. Recombinant secreted embryonic alkaline phosphatase (SEAP) expression was induced by medium exchange and temperature shift. Maximum SEAP activities of up to 63 U/mL were reached. A novel stirred glass bioreactor suitable for cell culture applications at benchtop…

Online Monitoring of CHO Cell Culture

Mammalian cell culture processes are very important in the production of recombinant proteins such as vaccines, antibodies, and pharmaceuticals for clinical applications. The physiology of mammalian cells is highly sensitive, leading to the need for sophisticated process technologies. A reliable sensor set-up is required to control major process parameters such as pH, dissolved oxygen, carbon dioxide, cell density, and feed rates. If such set points are not controlled tightly, then product quality and quantity might be altered. In addition, a…

Single-Use Solutions for Bulk-Powder Transfer

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).

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 Cadence™ 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 KanCapA™

Developing robust and scalable purification processes for monoclonal antibodies (mAbs) can save time and money. KANEKA’s protein A chromatography resin, KANEKA KanCapA™, 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 KanCapA™. The Chinese hamster ovary (CHO) cell culture…