SSCI, part of AMRI’s Global Analytical Services, has increased capacity in response to industry demand for the company’s cGMP particle characterization services by implementing Malvern’s next-generation laser diffraction instrument Mastersizer 3000.
“The ubiquity of Malvern Mastersizer instruments throughout the pharmaceutical industry, consistency of data across instruments, and Malvern Instruments’ continuing commitment to comply with data integrity requirements has led to SSCI’s choice of the Mastersizer 3000 to further expand its cGMP capabilities for particle size analysis,” Patricia Andres, Ph.D., director particle engineering at SSCI. “Measuring and monitoring the particle size of active pharmaceutical ingredients (APIs) and excipients are essential, due to the potential impact of particle size on downstream manufacturing processes, and also the delivery, stability, bioavailability and efficacy of the final drug product.”
Malvern Panalytical’s technologies confirm the identity, activity, molecular conformation, morphological properties, solid form and stability of APIs and excipients. Their solutions scale with the changing requirements of different stages in the development pipeline, ensuring workflow efficiencies are achieved all the way through to manufacture. To date, SSCI has developed more than 300 methods for the particle size analysis of APIs and drug products using its current stable of Malvern Mastersizers. Additionally, AMRI’s SSCI team has validated a significant portion of these methods for use in cGMP release testing.
“Our team of scientists has a demonstrated record of achievement and expert knowledge needed to deliver meaningful particle size data to its customers in the pharmaceutical, chemical and other industries where particle size is a critical process attribute,” says David A. Engers, Ph.D., general manager of AMRI’s SSCI site. “Our biopharmaceutical customers have frequently relied on SSCI for sophisticated solid-state techniques, including development of an ATR-IR method, validation of XRPD and particle size characterization methods.”