December 19, 2017
West Lafayette, Ind. (December 19, 2017) – 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.”
AMRI SSCI, LLC (SSCI), a division of AMRI (AMRI), provides industry leading contract solid-state and analytical testing services and exists to help companies in the pharmaceutical, food, agrochemical, and other chemical industries develop better products and get them to market more quickly. Over the past quarter century, SSCI has provided comprehensive cGMP research and analytical services in the characterization and chemistry of solid materials, with particular expertise in small and large molecules being investigated for pharmaceutical use. SSCI’s offerings include early candidate support services (in vitro analysis, stability, solubility, dissolution, excipient compatibility), solid-form screening and polymorph, salt and co-crystal screening, form selection, particle engineering (process development, particle size method development), property improvement, crystallization of difficult materials, process control, biochemical analysis, full analytical chemistry support including method development and validation, intellectual property consulting and litigation support, and related research activities. For more information about SSCI’s analytical and solid-state services, please contact 1-800-375-2179 (1-765-463-0112).
About Malvern Panalytical
Malvern Panalytical technologies are used by scientists and engineers in a wide range of industries and organizations to solve the challenges associated with maximizing productivity, developing better quality products and getting them to market faster. Our mission is to create superior, customer-focused solutions and services to deliver tangible economic impact through chemical, physical and structural analysis of materials. Underpinned by extensive industry knowledge and technical and applications expertise, Malvern Panalytical instruments help users better understand a wide variety of materials, from proteins and polymers to metals and building materials. Our technologies enable the measurement of parameters such as particle size, shape and zeta potential, biomolecular interactions and stability, rheological properties, elemental concentrations and crystallographic structure. Highly reliable and robust characterization of these properties is fundamental to predicting how a product will behave during use, to optimizing its performance and achieving manufacturing excellence.
Malvern Panalytical was formed by the merger of Malvern Instruments and PANalytical on 1st January 2017, and employs over 2,000 people worldwide. With R&D and manufacturing sites in North America, Europe and China and a global sales and service presence, we provide unrivalled levels of customer support. Malvern Panalytical is a strong player and innovator in the materials characterization market, providing expert solutions for superior actionable insight.
Malvern Panalytical is part of Spectris plc, the productivity-enhancing instruments and controls company.