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A Look at the Characterization of Mammalian Cell Lines
Cell banks must be extensively characterized to assess the cell source with regard to its identity, the presence of other cell lines, and adventitious/ endogenous agents or molecular contaminants. However, the tests used in this process are species specific and can vary depending on the history of the cell line and the type of media components that may be present. The following are assays that need to be considered. Read the full text of this application note in the PDF…
Development of a Novel Cold-Chain Tubing, FP-FLEX™, and Single-Use Freezing Bag: For Working Cell Banks Enabling Closed-System Processing to Temperatures As Low As –196 °C
Working cell banks (WCBs) are commonly applied to initiate cell culture manufacturing campaigns to produce therapeutic proteins. Those campaigns typically begin with the inoculation of cells previously cryopreserved in vials. Although vials are typically used to establish WCBs and initiate manufacturing campaigns, they are not optimal for the growing demands of commercial production.
Billion-Cell Hypoxic Expansion of Human Mesenchymal Stem Cells in BioBLU® 5c Single-Use Vessels
We demonstrate the success of large clinical-scale culture of human adipose-derived mesenchymal stem cells in an industrial single-use vessel at a 3.75-L working volume. The vessel provides a precisely regulated environment for the growth of stem cells under carefully controlled simulated physiological conditions. The monitoring of the cultures allowed us to accurately regulate their performance, optimizing their growth while at the same time demonstrating appropriate stem cell markers coupled with differentiation assays performed at the end of the culture period.…
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 × 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).