We offer industry leading expertise in particle engineering of Small Molecules, from early clinical development through to process validation and commercial supply. Our team's extensive knowledge and range of micronization technologies are a key component of our integrated network of development and manufacturing facilities. State-of-the-art milling technologies include comprehensive high containment (HPAPI) capabilities for working with compounds down to 50 ng/m³ requiring glove box isolation and cryogenic milling. With 19 GMP clean room suites and a wide selection of mill type and scale for commercial production of kilograms to tonnes, our site has the unrivalled capacity to support clients' micronization needs throughout a product's lifecycle. In addition to handling API and HPAPI, the Monteggio site has over three decades of experience in handling narcotics and controlled substances, hormones and steroids.
Our long history of success enables our pharmaceutical clients to optimize particle size and size distribution to influence a range of properties critical to a successful medicine. Our scientists and engineers apply their micronization knowledge gained from experience with over 1,000 compounds to improve drug substance stability, flowability, dissolution and bioavailability to provide solutions for oral solid, inhaled and other drug delivery modes. Our site includes a dedicated micronization research and development suite and an analytical laboratory focused on solid-state characterization. Our facility has been regularly inspected by and is registered with FDA; SwissMedic; Japan Ministry of Health, Korea FDA and Australian Department of Health. Today and tomorrow, our clients and their patients can be confident in our commitment to deliver products of the highest standard consistently.
Salvatore is the Head of the NPI&MSAT department at Lonza Monteggio and a Subject Matter Expert in size reduction across our network. His team in Monteggio follows the milling and micronization process during development and scale-up, right up to the point of industrial-scale validation. We deal with both process development and analytical characterization.