Italian Stevanato Group, through its laboratory SG Lab, has signed a partnership agreement with Toxikon Europe, the Belgian Contract Research Organization (CRO), to include extractables and leachables analysis to its chemical-analytical testing services.
The collaboration is based on a mutual exchange of best-in-class knowledge, expertise and capabilities. SG Lab is specialized in analytical chemistry, material properties, physical and mechanical performances to study the potentialinteractions between drugs and glass containers.
Over 35 years, Toxikon Europe has built a suite of world-class scientific services (extractables & leachables, toxicological assessments, impurity identifications and biocompatibility testing) to support the pharmaceutical companies. This service is based upon unique set of advanced analytical methodologies, using cutting-edge technologies and state-of-the-art instrumentation. In addition, Toxikon Europe developed a wide range of exclusive analytical and toxicological databases, which allow their staff to further optimize their methodologies and data interpretation.
The joint offer provides pharma companies with certification services able to address increasingly demanding global regulatory requirements. It also allows optimizing and customizing the glass container and its closure based on the study of the entire drug container’s life cycle.
“Thanks to this agreement, SG Lab can support pharmaceutical customers since the early stages of a new drug development. We help them in the selection of the best glass container including closure system, taking into account all the relevant aspects (compatibility, stability, quality).” – says Odra Pinato, SG Lab Analytics Coordinator – “Combining skilled glass experts with Toxikon’s experienced scientists and cutting edge laboratory capabilities, we now can offer a comprehensive analytical service support”.
“By bundling forces with SG Lab now we can leverage the collective expertise of SG Lab (glass testing, physical testing and container/closure integrity testing) with our in-depth scientific knowledge and expertise in extractables and leachables testing (including subsequent toxicological assessments) and container/drug interaction evaluations. This unmatched technical and scientific combined support should allow pharmaceutical and biopharmaceutical companies moving much faster in the qualification and acceptance process of their selected container and closure systems. At the end, it is all aboutguaranteeing patient safety and well-being, and we hope we can make a substantial contribution to achieve this.” – says Piet Christiaens, Toxikon Europe’s Scientific Director“.