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0348101270
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Special Issues for Synthetic Antisense Oligonucleotides
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Sofer, G., Zabriskie, D. W., Eds.; Marcel Dekker: New York, Chapter 16
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Srivatsa, G. S.; Ravikumar, V. T.; Scozzari, A. N.; Cole, D. L. Special Issues for Synthetic Antisense Oligonucleotides. In Biopharmaceutical Process Validation; Sofer, G., Zabriskie, D. W., Eds.; Marcel Dekker: New York, 2000; Chapter 16, pp 309-327.
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0031963427
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Affinitak (ISIS 3521) is targeted to the 3́-untranslated region of PKC-α mRNA selectively inhibiting PKC-α gene expression. This oligonucleotide inhibits the growth of a variety of tumor types in vivo using nude mouse tumor xenografts and sequence-specific antitumor activity supports an antisense mechanism of action in vivo. Clinical evaluation (pivotal Phase III) of this drug in humans as potential treatment for nonsmall cell lung cancer is currently ongoing. Geiger, T.; Muller, M.; Dean, N. M.; Fabbro, D. Anticancer Drug Des. 1998, 13, 35.
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0034385487
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0346212539
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16
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0348101272
-
-
note
-
Experience has taught us that yields expressed in terms of weight/μmole of loaded support are more reliable than those expressed in terms of optical density/μmol.
-
-
-
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17
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0027942382
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19
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0346840606
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note
-
The 91% full-length is typical when the entire DMT-on peak is collected. Much higher purity (∼96-97%% full-length) is easily achieved by efficient fractionation of the DMT-on peak. Fractionation of DMT-on peak results in less than a 5% loss of full-length material.
-
-
-
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20
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0346840607
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note
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The purified full-length by IP-LC-MS is less than CGE values since the former analytical tool is efficiently able to distinguish and quantify process-related species such as depurinated oligonucleotides that comigrate in CGE.
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0346840604
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note
-
DPA has viscosity of 1.4540 vs 1.4660 for DCA.
-
-
-
-
51
-
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0348101269
-
-
note
-
It was found that 40-60% of total eluted DMT groups are in the "colorless" initial eluent.
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-
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52
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0037708617
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