Search results for " surfac"
Poster
Validation of Cytodex™ Gamma microcarrier-based virus production in single-use bioreactor systems
A majority of cell lines commonly used for viral vaccine production are anchorage-dependent and require expansion on solid surfaces. Here, we describe different approaches for the cultivation of Ver…
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
NIR spectroscopy is a very popular method of analyzing solid and liquid raw materials because it is sensitive to matrix modifications such as surface area, sample morphology, and other sample properti…
Poster
Biacore™ systems in vaccine development and production
The growing public awareness of a potential pandemic requiring rapid treatment of millions of healthy individuals has spurred renewed interest in vaccines. Vaccination campaigns mean that often very…
Article
Antibody Production in Microbial Hosts
Aglycosylated antibody fragments showing selective binding to FcγRIIa were isolated by yeast surface display and flow-cytometry screening. In another study, researchers employed a knob-into-hole techn…
Article
The Metrics of Quality Culture
On the surface, the questions just seem to be a regurgitation of information contained in the APR or PQR. Upon closer evaluation, however, it is clear that FDA is trying to measure whether a company d…
Article
Best Practices in Qualification of Single-Use Systems
• “Equipment should be constructed so that surfaces that contact raw materials, intermediates, or APIs do not alter the quality of the intermediates and APIs beyond the official or other established s…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
Finished surfaces should be smooth and properly polished, and equipment should be appropriately designed and assembled in a way that facilitates cleaning and prevents microbial growth (i.e., no dead l…
Article
Robust Optimization, Simulation, and Effective Design Space
The visualization of the design space is of the mean (average) in the response surface (see Figure 3) relative to the limits of the CQAs. Many think that being anywhere in the white space will achieve…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Aggregation typically occurs because of nucleation, surface-induced factors, as a result of conformationally or chemically altered monomers, or association of native monomers (2). When a protein has b…
Article
SEC in the Modern Downstream Purification Process
In these cases, the resin matrix in the pore is modified with ionic charges, affinity ligands, or even hydrophobic groups, and the outer surface is left essentially inert. Only those molecules small e…