Sponsored Content
August 2015 August 2015
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 used to simplify preparation of a high-density cell bank without the need for a separate centrifugation step. In combination with perfusion, this cell bank was used to shorten the overall seed expansion process, from cryovial to the N – 1 bioreactor step (Figure 1).
Read the full text of this application note in the PDF (Login required).
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).
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 sterility.
Read the full text of this application note in the PDF (Login required).
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).
byMin Park
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 (Login required).
Sponsored Content
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 °CDevelopment 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.
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. With a view to future cellular therapy exploitation, every step from initiation to conclusion in the expanded bioreactor vessel was performed with single-use disposables.
Read the full text of this application note in the PDF (Login required).
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).
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 × 10
6
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 scale was designed by Finesse Solutions, Inc. With a maximum working volume of 2.0 L, this bioreactor is controlled by the Finesse G3Lab controller.
Read the full text of this application note in the PDF (Login required).
+1
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 steady cell-concentration measurement is necessary to plan feeding strategies.
Read the full text of this application note in the PDF (Login required).
+3
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).
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).
Since the approval of tPA derived from Chinese hamster ovary (CHO) cells in 1986, stable expression of recombinant proteins has become a very important system for the manufacture of therapeutic proteins. With an increasing number of therapeutic proteins in development, the demand for fast and robust development of manufacturing cell lines is still increasing. During the past 30 years, the productivity of stable recombinant cell lines could be increased from <100 mg/L to several g/L. The huge increase in productivity has been achieved by
Read the full text of this application note in the PDF (Login required).
Sponsored Content
Jun 5 - Jun 6, 2024
Jun 5 - Jun 6, 2024
Exploit Advances in Exosomes to Improve Efficiencies in Drug Delivery: Connect with senior-level executives and scientists who will share new data and novel case studies on advancing EV products through clinical stage towards commercialization
Learn More
