Quality Aspects of Oligonucleotide Drug Development: Specifications for Active Pharmaceutical Ingredients
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Quality Aspects of Oligonucleotide Drug Development: Specifications for Active Pharmaceutical Ingredients Daniel Capaldi, Kathy Ackley, Doug Brooks, Judy Carmody, Ken Draper, Rao Kambhampati, Matthias Kretschmer, Daren Levin, James McArdle, Bernhard Noll, Ramesh Raghavachari, Ipsita Roymoulik, B.P. (Bob) Sharma, René Thürmer and Fran Wincott Drug Information Journal 2012 46: 611 originally published online 14 May 2012 DOI: 10.1177/0092861512445311 The online version of this article can be found at: http://dij.sagepub.com/content/46/5/611
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Quality
Quality Aspects of Oligonucleotide Drug Development: Specifications for Active Pharmaceutical Ingredients
Drug Information Journal 46(5) 611-626 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861512445311 http://dij.sagepub.com
Daniel Capaldi, PhD1, Kathy Ackley, PhD2, Doug Brooks, PhD3, Judy Carmody, PhD4, Ken Draper, PhD5, Rao Kambhampati, PhD6, Matthias Kretschmer, PhD7, Daren Levin, PhD8, James McArdle, PhD9, Bernhard Noll, PhD10, Ramesh Raghavachari, PhD6, Ipsita Roymoulik, PhD11, B.P. (Bob) Sharma, PhD12, Rene´ Thu¨rmer, PhD13, and Fran Wincott, PhD14
Abstract This article, which is the first in a planned series intended to address chemistry, manufacturing, and control (CMC) aspects of therapeutic oligonucleotides, examines the topic of specifications for active pharmaceutical ingredients (APIs). The authors attempt to present basic scientific considerations for the broadest range of oligonucleotide APIs. Tests and analytical methods suitable for the control of single- and double-stranded oligonucleotide APIs and conjugated oligonucleotide APIs are discussed. Keywords therapeutic oligonucleotides, active pharmaceutical ingredients, specifications, specification tests, analytical methods
The Planned Series of Papers Synthetic oligonucleotides present tremendous potential to bring new therapies to large numbers of patients, many of whom have unmet medical needs and face serious illness. Therapeutic approaches are varied. The first clinical strategy is based on antisense technology, but today’s development activities encompass a number of additional strategies. The potential of synthetic oligonucleotides is being exploited in RNA interference (RNAi), which broadly includes the technologies of short interfering RNA (siRNA) and microRNA (miRNA), and in immune stimulation, aptamers and spiegelmers, oligonucleotide decoys, and splice modula
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