S Esposito, L Orsatti, V Pucci - Xenobiotica, 2022 - Taylor & Francis
Many peptide drugs such as insulin and glucagon-like peptide (GLP-1) analogues are successfully administered subcutaneously (SC). Following SC injection, peptides may …
JR Cohen, MK Joubert, S Tabassum, A Capili… - Journal of …, 2024 - Elsevier
Multiproduct manufacturing of biotherapeutic proteins generate cleaning-induced protein degradants because of extreme pH and temperature conditions during the cleaning process …
SG Thacker, C Her, L Kelley-Baker… - Frontiers in …, 2022 - frontiersin.org
Unintended immunogenicity can affect the safety and efficacy of therapeutic proteins and peptides, so accurate assessments of immunogenicity risk can aid in the selection …
Background The efficacy and safety of therapeutic proteins are undermined by immunogenicity driven by anti-drug antibodies. Immunogenicity risk assessment is critically …
JR Cohen, SR Brych, S Prabhu, V Bi… - Pharmaceutical …, 2024 - Springer
Abstract Background and Purpose There is concern that subvisible aggregates in biotherapeutic drug products pose a risk to patient safety. We investigated the threshold of …