05 September 2023 – Å·ÃÀÊìÅ®ÂÒÂ× (Element), a leading global Testing, Inspection and Certification (TIC) company, has launched an integrated offering for its pharmaceutical services. This strategic initiative brings together the expertise and Å·ÃÀÊìÅ®ÂÒÂ× of its recent North American acquisitions of Nanosyn and JMI labs into its existing Life Sciences business. This integration creates a team of over 1,400 scientists and chemists operating across a worldwide network of laboratories.
Combining the Contract Development & Manufacturing Organization (CDMO) and Contract Research Organizations (CRO) allows Element to provide robust support to its customers at every stage of their product's life cycle. The large team combines extensive knowledge in scientific and regulatory fields with a wide selection of advanced equipment and creative solutions, ensuring it can deliver exceptional expertise and innovation.
With a strategic location in the San Francisco Bay Area, Nanosyn’s laboratories function as a CDMO, providing a seamless platform to cater to customers throughout the development life cycle. Boasting a history dating back to 1998, Nanosyn has a remarkable track record of advancing small molecules from initial hits to Investigational New Drugs (IND), supported by an exceptional team of over 50 scientists equipped with cutting-edge technology and efficient operations.
Nanosyn’s laboratory in Santa Clara specializes in chemistry and drug discovery services, housing one of the largest chemical inventories of any pharmaceutical synthesis lab in the US. The dedicated scientists at Santa Clara also boast co-authorship of over 300 patents. The company’s Santa Rosa lab is an FDA-inspected kilo lab facility, offering manufacturing Å·ÃÀÊìÅ®ÂÒÂ× across 6 GMP suites and 2 class 10,000 clean rooms, alongside state-of-the-art R&D facilities.
Furthermore, Element has established a market-leading CRO based in North Liberty, Iowa, previously known as JMI Laboratories. The CRO boasts a proprietary and long-standing SENTRY Antimicrobial Surveillance Program, which plays a vital role in US-FDA regulatory submissions and new drug applications. With a dedicated team of over 70 professionals, the CRO is meets and exceeds the Clinical Laboratory Improvement Amendments Act 1988 and is CLIA certified for clinical trials and possesses the capacity to conduct Good Laboratory Practice (GLP) studies, enabling complete lab-to-market product support for customers through drug development, molecular testing, clinical trials, medical writing, and surveillance services.
Marie Keeley, Vice President Life Sciences America at Element said “Pharmaceutical companies face a myriad of challenges in their pursuit of developing new products. The industry contends with supply chain disruptions, escalating development costs, staffing constraints, and manufacturing delays, making the process of bringing a new drug to market more demanding than ever before.
With the unveiling of our integrated pharmaceutical services platform, Element Life Sciences now stands ready to address these challenges head-on. By providing Contract Research Organization (CRO) and Contract Development & Manufacturing Organization (CDMO), plus Testing, Inspection and Certification (TIC) services, we offer comprehensive support to customers throughout the entire product life cycle. Our team boasts deep expertise in scientific and regulatory domains, complemented by a diverse array of cutting-edge equipment and innovative solutions.”
Element’s global Life Sciences division reaches across a network of laboratories to deliver complete and comprehensive scientific solutions. This network supports customers’ end-to-end product development lifecycles from early R&D to navigating complex regulatory approvals, while also supporting the production stages and beyond. Element Life Sciences stands as a steadfast partner, empowering pharmaceutical companies to overcome obstacles and advance their groundbreaking innovations in the dynamic and ever-evolving landscape of the life sciences industry.