Wednesday, November 10, 2010 Daily Archives

A New, Robust Method for Protein Elution from Ceramic Hydroxyapatite

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Ceramic hydroxyapatite (CHTâ„¢) is used for protein purification owing to its superior removal of all process-stream impurities (aggregates, HCP, viruses, endotoxin, protein A, DNA, etc.). At commercial scale CHT performance can be impacted due to the release of protons during elution. This proton release lowers mobile phase pH which may impact the robustness of CHT particles. We have developed a novel, patent-pending technology called the surface neutralization system (SNS), which desorbs protons from the surface of CHT prior to elution.…

November 10, 2010

Cell Culture Design Space Modeling using a Scale-Down Approach

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As an industry initiative to “provide assurance of quality,†the ICH Q8 guideline proposes building quality into the design of experiments by defining the process design space within which critical product quality attributes are within an acceptable range. A characterized design space not only enhances process knowledge but also can later be utilized for process validation and regulatory filings, saving on the time and cost of additional filings if process changes are implemented in the future. Because it is neither…

November 10, 2010