Italian-based Stevanato Group, a leading producer of glass primary packaging and provider of integrated services for combination products, and Nelson Laboratories, LLC, a global provider of lab testing and expert advisory services signed today a partnership agreement that will provide Extractables and Leachables testing at SG US Technology Excellence Center in Boston, MA, USA.
The collaboration combines the best-in-class knowledge, expertise, and capabilities of both companies. The SG US TEC, opening in Boston on September 24th, will provide analytical services on material properties, physical and mechanical performances to investigate the potential interactions between drugs and glass-based primary packaging. Thanks to this collaborative agreement, Nelson Labs will support the SG US TEC with toxicological evaluation, biocompatibility, microbiology, and extractables and leachables testing.
Over the years, Nelson Labs has built a set of advanced analytical methodologies, using cutting-edge technologies and state-of-the-art instrumentation. Besides, Nelson Labs boasts a wide range of exclusive analytical and toxicological databases, allowing its staff to optimize their methodologies and data interpretation further.
“With our laboratory in Italy, SG Lab, we have collaborated for many years with Nelson Labs’ European Center of Excellence, Nelson Labs Europe. We are glad to extend this collaboration also to our US customers. Its recognized expertise in extractables and leachables testing applied to biologics is crucial to ensure that the packaging system does not adulterate the drug product, ensuring drug efficacy, and patient safety. Combining SG US TEC skilled scientists with Nelson Labs’ experts and cutting-edge laboratory capabilities, we can now offer comprehensive analytical services assessing drug compatibility with container closure systems and devices/combination products.” said Abizer Harianawala, Site Leader at US TEC.
“When it comes to the E&L qualification process of the primary packaging, biologics face additional challenges compared to small-molecule drugs. The efficacy of the therapeutic biologic could be compromised through undesirable interaction of leachables with the drug substance, resulting in side-effects and product recalls. Nelson Labs’ in-depth scientific knowledge of extractables and leachables testing – including toxicological assessments – will allow biopharmaceutical companies to move much faster in the qualification and acceptance process of their selected container closure system.” said Piet Christiaens, Scientific Director at Nelson Labs Europe.