The client was developing a pMDI drug product with a complex multi-stage manufacturing process involving API re-crystallization and particle size reduction steps . Wide-ranging validated analytical methods (physical, solid-state, chromatographic) were required to release AP I at various stages of the manufacturing process and to support research activities. Agenda 1 was able to deliver all required tests from its single site and to cGMP with rapid turnaround of results.
Agenda 1 established and validated a suite of 18 analytical methods, these included particle size, XRPD, BET SSA, SEM, DSC, KF, FTIR, HPLC assay I impurities and GC (residual solvents), TAMC I TYMC and specified organisms, as well as standard compendial monograph tests; these were written into individual analytical methods, each of which was supported by validation I verification reports. The established methods were used to release test material from all stages of the manufacturing process (API raw material to finished product), and to carry out chemical and so lid-state stability and relaxation studies. Crucially, Agenda 1 supported manufacturing process development by carrying out a range of lab-scale micronization studies with associated analysis .
The client was provided with cGMP validated methods for a wide range of analysis undertaken within a single-site facility. These methods continue to be used for release testing purposes as the product moves towards commercialization. The client went on to commission a similar project involving 11 analytical methods for a different API .