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May 01, 2013 (Vol. 33, No. 9)

Critical Tools for Oligo Characterization

  • The emphasis on process understanding has been part of pharmaceutical development strategy since FDA’s 2003–2004 promulgation of GMPs for the 21st Century . Oligonucleotides were almost nonexistent in major pharmacopoeias at the time. Now that oligo drugs are nearing late development and commercialization, analytical tools for speeding process development ...

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