GDUFA Research Outcomes

Oligonucleotide APIs

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to complex active pharmaceutical ingredients that are oligonucleotides, including antisense oligonucleotides (ASOs) and small interfering RNAs (siRNAs), and associated impurities in generic products.

• All(44)
• Posters(10)
• Presentations(21)
• Papers(13)

• The Use of Multiple Liquid Chromatography Methods Augmented by Phosphorus-31 Nuclear Magnetic Resonance to Characterize the Diastereomer Composition in Synthetic Oligonucleotides

  Ali, Mohsin; Manghrani, Akanksha; Szramowski, Mirandia; Abdel-Megied, Ahmed M; Liang, Likan; Aberg; Nils F; Yang, Kui; Chen, Kang; Wang, Yan; Zhang, Deyi; Fletcher, Steven; Brinson, Robert G; Jones, Jace W

• Immunogenicity of Therapeutic Peptide Products: Bridging the Gaps Regarding the Role of Product-Related Risk Factors

  Puig,M; Shubow, S

• White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment Beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation

  Tounekti, O; Prior, S; Wassmer, S; Xu, J; Wong, A; Fanf, X; Sonderegger, I; Smeraglia, J; Huleatt, J; Loo, L; Beaver, C; DelCarpini, J; Dessy, F; Diebold, S; Fiscella, M; Garofolo, F; Grimaldi, C; Gupta, S; Hou, V; Irwin, C; Jani, D; Joseph, J; Kalina, W; Kar, S; Kavita, U; Lu, Y; Marshall, J-C; Mayer, C; Mora, J; Nolan, K; Peng, K; Riccitelli, N; Scully, I; Seitzer, J; Stern, M; Wadhwa, M; Xu, Y; Verthelyi, D; Sumner, G; Clements-Egan, A; Chen, C; Gorovits, B; Torri, A; Baltrukonis, D; Gunn, G; Ishii-Watabe, A; Kramer, D; Kubiak, RJ; Mullins, G; Pan, L; Patridge, MA; Poetzl, J; Rasamoelisolo, M; Sirtori, FR; Richards, S; Saad, OM; Shao, W; Song, Y; Song, S; Staack, RF; Wu, B; Manangeeswaran, M; Thacker, S

• Proceedings of the 15th European Immunogenicity Platform Open Symposium on Immunogenicity of Biopharmaceuticals

  Tourdot, S; Bloem, K; Champion, L; De Groot, AS; Ducret, A; Garidel, P; Grudzinske-Gpebel, J; Gutknecht, M; Hickling, T; Horling, F; Ichetovkin, M; Johnson, A; Jyamubandi, I; Karle, A; Kromminga, A; Kurtulmus, EA; Loeff, F; Maillere, B; Michaut, L; Minelli, F; Nielsen, M; Nayak, V; Nelson, R; Pallardy, M; Pattyn, S; Pedras-Vasconelos, J; Pepermans, E; Poyau, A; Reichel, M; Rosenberg, A; Sauna, Z; Saxena, M; Smith, N; Snoeck, V; Thoo, L; Tovey, M; Verthelyi, D; Wuttke, R; Yerly, D; Kramer, D

• Quantitative Solid-State NMR Spectroscopy (qSSNMR) in Pharmaceutical Analysis

  Zheng, Z; Chen, K; Liu, Y; Munson, E; Su, Y

• Clinical Ocular Exposure Extrapolation for an Ophthalmic Ointment Using PBPK Modeling and Simulation

  Le Merdy, Maxime; Tan, MingLiang; Lukacova, Viera

• Impact of Ionizable Lipid Source on the In Vitro Performance of siRNA Loaded Lipid Nanoparticles

  Ranjbar, Sheyda; Shih, Kuo-Chih; O’Reilly Beringhs, Andre; Qin, Bin; Wang, Yan; Lu, Xiuling

• Effect of Ionizable Lipid Source on the Quality Attributes of siRNA Lipid Nanoparticle Therapeutics

  Ranjbar, Sheyda; Shih, Kuo-Chih; O’Reilly Beringhs, Andre; Qin, Bin; Wang, Yan; Lu, Xiuling

• Decoding Complexity in Synthetic Oligonucleotides: Unraveling Coeluting Isobaric Impurity Ions by High Resolution Mass Spectrometry

  Abdullah, AM; Sommers, Cynthia; Rodriguez, Jason D; Zhang, Deyi; Kozak, Darby; Hawes, Jessica; Sapru, Mohan; Yang, Kui

• An Accurate and Fast 31P qNMR Assay Method for Oligonucleotide Therapeutics

  Li, Jiayi; Chen, Fu; Zhang, Deyi; Wang, Yan; Kozak, Darby; Chen, Kang