The Washington-based CDMO AGC Biologics has been tapped to manufacture the type 1 diabetes treatment Tzield from Provention Bio.
AGC Biologics will produce Tzield at its Seattle protein biologics site. It was chosen after AGC helped to guide the product through process performance qualification (PPQ) manufacturing and validation batches, and, ultimately, FDA approval. Tzield is the only immunomodulatory treatment approved to delay the onset of Stage 3, type 1 diabetes in children and adults aged eight and older.
Details about the size of the contract or how many doses AGC will manufacture were not immediately available. The Seattle facility has multiple manufacturing lines and has been producing biologics for more than 30 years.
“This achievement demonstrates our Seattle site’s increasing track record in commercial manufacturing, which is aligned with AGC Biologic’s purpose of bringing hope to life,” said Kevin Ingham, general manager of AGC Biologics’ Seattle site, in a
