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  • Grasping Lyophilization Product and Process Parameters for Biopharma
    mysteries remain. Apart from lyoprotectants, other substances are also commonly added to the protein solution prior to drying. Some may also have been carried over in the solution during downstream processing. They may include pH buffers, surfactants and salts. A common additive, phosphate-buffered
  • Proper Calibration Techniques (.pdf)
    ) of the reference electrode, by comparing these values to those of known buffer solutions. The EXA Instruments utilize preprogrammed buffer tables in the Auto Cal function. These pre-programmed values are based on pure N.I.S.T. buffers, which correspond to 6.86 pH, 4.01 pH and 9.18 pH at 25° C.
  • Medical Device Link . Microspheres, part 2:
    ), buffer pH should be at, or slightly more basic than, IgG's isoelectric point (that is, pH 8), where the protein is in its most relaxed, compact form ( ). Gibbs and colleagues (Costar Corp., Kennebunkport, ME) say, "Binding is favored when pH is close, but not equal to, the pI [isoelectric point
  • Guided Wave Radar at Genentech: A Novel Technique for Non-invasive Volume Measurement in Disposable Bioprocess Bags
    in a simple tray, but larger bags are typically housed in a bioprocess container --a plastic or stainless steel bin that supports the filled bag. Bioprocess containers greater than 500L are often stationary while smaller bins are typically portable. New sensor technologies for pH, DO, conductivity
  • Chromatography Roundup
    volumes, binding capacities and control of processes. While process analytical technologies (PAT) are already being applied to monitor pH, UV and conductivity, the PAT initiative is causing manufacturers to question what more can be done. Can peak-shape analysis be used for batch acceptance or rejection
  • Medical Device Link . Stability issues for protein-based in vitro diagnostic products
    to the shelf life of dried components. Liquid stabilization is affected by a larger number of variables. Temperature, microbial contamination, and pH level or buffer can all affect stability. Additionally, this article will discuss why performance problems should not be automatically attributed

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