The fill-finish facility in Bloomington, formerly owned by Catalent, was cited for eight observations including persistent contamination and quality systems deficiencies.
The 30,000-square-meter facility is designed to produce approximately 100 million units of pre-filled syringes and vials annually when operations begin in 2027.
The new pilot-scale facility expands peptide API manufacturing capabilities for process scale-up, purification, and lyophilization supporting global drug development programs.
Go beyond similarity in this webchat with a Thermo Fisher Scientific expert on how a p-value-based multivariate residual approach verifies pharmaceutical raw materials.
