Upstream Processing

One-Step Seed Culture Expansion from One Vial of a High-Density Cell Bank to a 2,000-L Production Bioreactor

We describe the use of perfusion cell culturing to reduce processing time, simplify operations, and maximize equipment use in seed culture expansion processes. Seed culture expansion is commonly performed using several consecutive batch cultures. Starting from a cryopreserved cell stock, the initial culture expansion is typically performed using shake flasks, whereas the final steps are bioreactor cultures. Such a procedure is time consuming and labor intensive, and each manual interaction constitutes a contamination risk for the culture. Here, perfusion was…

Setting the Containment Standard for Customization

From the outside, you’d be forgiven for thinking of a bioprocess container as a mere box. Yet it is this box — or magic box — that transports valuable fluids, buffers, and media along your in-process storage and handling supply chain. Read the full text of this application note in the PDF (Login required).

Reduce Cost, Increase Quality, and Shorten Cycle Time in Upstream Manufacturing with Single-Use Heat Exchanger

This technical note presents the benefits of using a single-use heat exchanger and its areas of application. Successful cell culture on a large scale requires close control of the culture environment in terms of temperature, pH, removal of waste products, and addition of fresh nutrients. To produce high yields of a desired protein, precise control over such parameters at every step in a process is required. Additionally, FDA regulations require that various steps be taken to control bioburden and maintain…

Biopharmaceutical Product Development: Helping to Develop Better Biologic Products Faster

From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. With over 80 years of experience, we have the deepest expertise, broadest offerings, and the most innovative technologies to help you get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and improved results. Catalent is your strategic partner for biologic drug development success. Read the full text of this application note in the PDF (Login required).

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…