Stevanato Group Seals Deal with Nelson Labs to Provide Extractables...

Pharma Tech Outlook: Pharma Tech Magazine

Stevanato Group Seals Deal with Nelson Labs to Provide Extractables & Leachables Testing Services

By Pharma Tech Outlook | Friday, September 11, 2020

Jeffery R. Nelson, CEO

SG US TEC will add biocompatibility, extractable & leachable testing, microbiology,  and toxicological evaluation to its analytical technology suite to investigate drug-container closure system interaction.

FREMONT, CA: Italian-based Stevanato Group, a producer of glass primary packaging and provider of integrated services for combination products, and Nelson Laboratories, a global provider of lab testing and expert advisory services, sign a partnership agreement that will offer Extractables and Leachables testing at SG US Technology Excellence Center in Boston, MA. The partnership combines the best-in-class knowledge, expertise, and potentials of both companies.

The SG US TEC, starting in Boston on September 24th, will offer analytical services on material properties, physical and mechanical performances to study the potential interactions between drugs and glass-based primary packaging. This collaborative agreement will support the SG US TEC with toxicological evaluation, microbiology, biocompatibility, and extractables and leachables testing.

Nelson Labs has developed a set of advanced analytical methodologies, using cutting-edge technologies and state-of-the-art instrumentation. It also boasts a wide range of exclusive analytical and toxicological databases, allowing its staff to streamline their methodologies and data interpretation further. Its proven expertise in extractables and leachables testing applied to biologics is vital to ensure that the packaging system does not adulterate the drug product, making sure drug efficacy and patient safety. Combining SG scientists with Nelson Labs’ experts and laboratory capabilities, the company can now offer comprehensive analytical services assessing drug compatibility with container closure systems and devices.

When it comes to the E and L qualification of the primary packaging, biologics face additional pain points compared to small-molecule drugs. The efficacy of the therapeutic biologic could be compromised through the interaction of leachables with the drug substance, resulting in side-effects and product recalls. Nelson Labs’ scientific knowledge will allow biopharmaceutical firms to move much faster in the qualification and acceptance process of their selected container closure system.

Stevanato Group is the largest, privately-owned designer and producer of primary glass packaging for the pharmaceutical sector. The group has developed its glass converting technology to provide the highest standards of quality. It comprises a wide set of capabilities dedicated to serving the biopharmaceutical and diagnostic industries.

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