Search results for " surfac" in Articles / App Notes
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…
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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…
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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…
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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…
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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…
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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…
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Mechanistic Modeling: Does it Have a Future in Process Development?
However, when it comes to reverse-phase chromatography or HIC, the mathematical description of hydrophobic interactions between surface and proteins are not optimal today making it difficult to use th…
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Trends in Single-use Bioreactors
It is still crucial for the end-user to carefully select the product contact surface (film), hardware, and technology, among other things, that best meet their needs.
Ang (Eppendorf): Many link si…
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Concentration and Diafiltration of Cell-Derived, Live Influenza Virus Using 750 C Hollow Fiber Filter Cartridge
In contrast to normal flow (dead-end) filtration (NFF), the feed is recirculated over a permeable membrane surface (cross flow).This application note describes the performance of GE HealthcareLife Sci…
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EMA Invites Comments on New Guidance for Vaccine Development
The guidance provided applies to vaccines for which ample regulatory experience has been gained, as well as to some novel types of vaccines based on established surface antigens.
The most notable …