Kilogram-Scale GMP Manufacture of Tirzepatide Using a Hybrid SPPS/LPPS Approach with Continuous Manufacturing
Contributor(s):: Frederick, Michael O., Boyse, Raymond A., Braden, Timothy M., Calvin, Joel R., Campbell, Bradley M., Changi, Shujauddin M., Coffin, Stephanie R., Condon, Carmel, Gowran, Olivia, Groh, Jennifer McClary, Groskreutz, Stephen R., Harms, Zachary D., Humenik, Ashley A., Kallman, Neil J., Klitzing, Nicholas D., Kopach, Michael E., Kretsinger, Juliana K., Lambertus, Gordon R., Lampert, Jeffrey T., Maguire, Laura M., Moynihan, Humphrey A., Mullane, Nessa S., Murphy, John D., O’Mahony, Marie E., Richey, Rachel N., Seibert, Kevin D., Spencer, Richard D., Strege, Mark A., Tandogan, Nil, Torres Torres, Frank L., Tsukanov, Sergey V., Xia, Han
The large-scale manufacture of complex synthetic peptides is challenging due to many factors such as manufacturing risk (including failed product specifications) as well as processes that are often low in both yield and overall purity. To overcome these liabilities, a hybrid solid-phase peptide...