For a recombinant protein to become a human therapeutic, its biophysical and biochemical charac-teristics must be well understood. These properties serve as a basis for comparison of lot-to-lot reprodu-cibility, for establishing the range of conditions to stabilize the protein during production, storage and shipping, and for identifying characteristics useful for monitoring stability during long-term storage.
A number of techniques can be used to determine the biophysical properties of proteins and to examine their biochemical and biological integrity. Where possible, the results of these experiments are compared with those obtained using naturally occur-ring proteins in order to be confident that the recombinant protein has the desired characteristics of the naturally occurring one.
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