Search results for " surfac"
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
Acidic fibroblast growth factor (FGF) readily degrades if heparin sulfate is not present on the surface of the target cells; therefore, heparin or synthetic dextran as a substitute is added to the med…
Article
Bioburden Control in the Biopharmaceutical Industry
Attempts have been made to apply these techniques to the microbiological monitoring of water, air, and surfaces in the pharmaceutical industry (14-16).
Establishing Microbiological Contro…
Poster
Adenovirus production in a single-use stirring tank bioreactor system
However, scale-up using these techniques is complicated and limited by the surface available for cell growth. One alternative is to scale up the production on microcarriers. Another solution is to us…
Article
Fusion Proteins Pose Manufacturability Challenges
Challener
Fusion proteins are engineered proteins that contain domains from different proteins that originate from different sources, such as a cell surface receptor or cytokine (i.e., interferon …
Article
Downstream Processing for Cell-Based Therapies
For instance, for the anchorage-dependent cells, after the cells are enzymatically dissociated into a single-cell suspension (whether that is detachment from microcarriers, culture surfaces, colonies,…
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
…sfer through the film layer (kfilm) around the bead particle, diffusion through the pore (Dpore) and surface (Ds) of the bead, and reaction rate at the binding site. A complete description of mass tr…
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Technologies used typically include ELISA, electrochemiluminescence, and surface plasmon resonance (Biacore, Cytiva) analysis.
Biacore, in particular, has become a workhorse of biopharmaceutical p…
Article
Ensuring Sterility in Small-Scale Production
…component processing area, gowning rooms, laminar flow hoods, floors, ceilings, walls, and equipment surfaces including those that come into contact with the product components as well as the product…
Article
Evaluating E&L Studies for Single-Use Systems
… capability of the solvent/solution
• Contact time
• Temperature
• Product contact surface area
• Material pre-treatment
• Material compatibility/resistance.
It is presumed th…
Article
Advancing Single-Use Technology Through Collaboration
The end-user can use this information to determine worst-case scenarios for each assembly based on surface areas and contact times. A toxicologist can determine thresholds of toxicological concern for…