Zosano Pharma Completes Manufacture of M207 Registration Batches
Zosano Pharma Corporation announced the release of three registration batches of M207, the Company’s lead development candidate.
The registration batches will be used to support Zosano’s New Drug Application (NDA) filing with the U.S. Food and Drug Administration (FDA). Twelve months of room temperature stability for a product candidate are typically required in order for the FDA to assess manufacturability and stability of a drug product. Zosano’s batches have been placed on stability per regulatory requirements and will complete the 12-month timepoint in September of 2019.
“This is a significant milestone for Zosano in the development of our lead product candidate, M207,” said Hayley Lewis, senior vice president, operations at Zosano Pharma. “Our process development and manufacturing teams have successfully established a robust process to scale up for commercial manufacturing of M207. We can now confidently say we have completed an important requirement in anticipation of our filing in Q4 2019, which is a monumental and very encouraging accomplishment.”