Universal Immunoassay Applied During Early Development of Large Molecules to Understand Impact of Immunogenicity on Biotherapeutic Exposure Journal title: The AAPS Journal Authors: Ami C. Bautista, Hossein Salimi-Moosavi, Vibha Jawa Subject(s): Medicine
Absorption, Distribution, Metabolism, and Excretion (ADME) Studies of Biotherapeutics for Autoimmune and Inflammatory Conditions Journal title: The AAPS Journal Authors: Yulia Vugmeyster, John Harrold, Xin Xu Subject(s): Medicine
Scientific Considerations for Generic Synthetic Salmon Calcitonin Nasal Spray Products Journal title: The AAPS Journal Authors: Sau L. Lee, Lawrence X. Yu, Bing Cai, Gibbes R. Johnsons, Amy S. Rosenberg, Barry W. Cherney, Wei Gu... Subject(s): Medicine
Summary of Confirmation Cut Point Discussions Journal title: The AAPS Journal Authors: Holly W. Smith, Michael Moxness, Robin Marsden Subject(s): Medicine
Prevalence and Isotypic Complexity of the Anti-Chinese Hamster Ovary Host Cell Protein Antibodies in Normal Human Serum Journal title: The AAPS Journal Authors: Li Xue, Rasheeda Johnson, Boris Gorovits Subject(s): Medicine
Phosphatidylinositol Containing Lipidic Particles Reduces Immunogenicity and Catabolism of Factor VIII in Hemophilia A Mice Journal title: The AAPS Journal Authors: Aaron Peng, Robert M. Straubinger, Sathy V. Balu-Iyer Subject(s): Medicine
Antidrug Antibody Assay Validation: Industry Survey Results Journal title: The AAPS Journal Authors: Boris Gorovits Subject(s): Medicine
Role of Glycosylation in Conformational Stability, Activity, Macromolecular Interaction and Immunogenicity of Recombinant Human Factor VIII Journal title: The AAPS Journal Authors: Matthew P. Kosloski, Razvan D. Miclea, Sathy V. Balu-Iyer Subject(s): Medicine
Development, Validation, and Clinical Implementation of an Assay to Measure Total Antibody Response to Naglazyme® (Galsulfase) Journal title: The AAPS Journal Authors: Joleen T. White, Lisa Argento Martell, Andrea Van Tuyl, Ryan Boyer, Laura Warness, Gary T. Taniguchi... Subject(s): Medicine
O-phospho-L-serine, multi-functional excipient for B domain deleted recombinant factor VIII Journal title: The AAPS Journal Authors: Razvan D. Miclea, Vivek S. Purohit, Sathy V. Balu-Iyer Subject(s): Medicine
Comparison of Neutralizing Antibody Assays for Receptor Binding and Enzyme Activity of the Enzyme Replacement Therapeutic Naglazyme® (Galsulfase) Journal title: The AAPS Journal Authors: Joleen T. White, Lisa Argento Martell, William S. Prince, Ryan Boyer, Lucy Crockett, Christopher Cox... Subject(s): Medicine
Effects of Replacement of Factor VIII Amino Acids Asp519 and Glu665 with Val on Plasma Survival and Efficacy In Vivo Journal title: The AAPS Journal Authors: Matthew P. Kosloski, Krithika A. Shetty, Hironao Wakabayashi, Philip J. Fay, Sathy V. Balu-Iyer Subject(s): Medicine
Development of a Method That Eliminates False-Positive Results due to Nerve Growth Factor Interference in the Assessment of Fulranumab Immunogenicity Journal title: The AAPS Journal Authors: Sheng Dai, Allen Schantz, Adrienne Clements-Egan, Michael Cannon, Gopi Shankar Subject(s): Medicine
A White Paper—Consensus and Recommendations of a Global Harmonization Team on Assessing the Impact of Immunogenicity on Pharmacokinetic Measurements Journal title: The AAPS Journal Authors: J. M. Sailstad, L. Amaravadi, A. Clements-Egan, B. Gorovits, H. A. Myler, R. C. Pillutla, S. Pursuho... Subject(s): Medicine
Stratification of Antibody-Positive Subjects by Antibody Level Reveals an Impact of Immunogenicity on Pharmacokinetics Journal title: The AAPS Journal Authors: Lei Zhou, Sarah A. Hoofring, Yu Wu, Thuy Vu, Peiming Ma, Steven J. Swanson, Narendra Chirmule, Marta... Subject(s): Medicine
