Impurities in Oligonucleotide Drug Substances and Drug Products - Capaldi, Daniel; Teasdale, Andy; Henry, Scott; Akhtar, Nadim; den Besten, Cathaline; Gao-Sheridan, Samantha; Kretschmer, Matthias; Sharpe, Neal; Andrews, Ben; Burm, Brigitte; Foy, Jeffrey (Nucleic acid therapeutics, 2017)
Keywords: Animals; Chemistry; Chemistry Techniques, Analytical - methods; Chemistry, Pharmaceutical - methods; Chromatography; Drug Contamination - prevention & control; Drug Design; Drug Industry - standards; Female; Humans; Impurities; Issues in Development; Limit of Detection; Male; Mass spectrometry; Mice; Models, Animal; Oligonucleotides; Oligonucleotides - analysis; Oligonucleotides - chemical synthesis; Oligonucleotides - therapeutic use; Patient Safety - standards; Pharmaceuticals; Product safety; Scientific imaging; qualification; identification; oligonucleotides; impurities