Gerresheimer AG and Nelson Labs NV announce strategic alliance regarding Extractables and Leachables lab testing for the Pharmaceutical and Biotech Industries

Gerresheimer AG, a leading global provider of healthcare & beauty and drug delivery systems for pharma, biotech and cosmetics and Nelson Labs, a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries are announcing today the establishment of a strategic partnership to support pharmaceutical and biotech companies in their development of primary packaging systems. The partnership between Gerrensheimer’s Gx Biological Solutions and Nelson Labs leverages the expertise and competencies of two leaders in science and technology to significantly reduce risk and time to market for primary packaging solutions for injectables. Through this collaboration Nelson Labs will conduct extractables & leachables (E&L) testing, toxicological risk assessments, impurity identifications, and biocompatibility testing of injectable primary container closure systems or components.

Piet Christiaens, Scientific Director, Nelson Labs
“I am extremely pleased that Gerresheimer and Nelson Labs have taken this very important step forward in joining our forces to provide customers with stellar testing and expert advice in container/closure qualification. From the initial discussions of the partnership, it was clear that both companies share the same values when it comes to service-oriented customer support. This partnership is designed to help the pharmaceutical industry take full advantage of our scientific leadership, unique Compounds Screener Database, personalized support, and other resources that will be offered through this alliance. This strategic partnership will allow Nelson Labs to further expand our position in the vibrant and rapidly developing Asia Pacific Region.”

Stefan Verheyden, Global VP, Gx Biological Solutions
“Thanks to this partnership with Nelson Labs, and its proven track record in the fields of container closure integrity (CCI) and E&L, we at Gerresheimer have become one of the world’s leading partners of the pharmaceutical and healthcare industries. Our broad portfolio includes many pharmaceutical packaging products and safe drug delivery systems such as insulin pens, inhalers, prefilled syringes, vials, cartridges, and bottles and containers for liquid and solid drugs with closure and safety systems. We have been serving the biologics market with our solutions for many years and have recently observed an increasing diversification of the market, its industry leaders, and their requirements. Therefore, we are extremely excited to enter this strategic partnership with Nelson Labs to further expand the support we offer biopharmaceutical companies.”

Jean-Edouard Rabier, Director, Business Development, Gx Biological Solutions
“With this agreement, Gx Biological Solutions will be able to offer an extended service package to our pharmaceutical and biotechnological customers for their new drug development and product life cycle management. We are now able to provide our customers the best selection of primary packaging systems (vials, syringes, and cartridges) made of glass or cyclic olefin polymer (COP) without any concerns about compatibility, stability, or safety of the drug product. Leading-edge scientific expertise, strong market recognition of Nelson Labs is definitely a must for Gx Biological Solutions to reach our objectives to be a scientific destination and a provider of best-in class primary packaging systems, with an end-to-end support to our customers.”

About Gx Biological Solutions
Gx Biological Solutions is an interdisciplinary team with global resources and cross-divisional product expertise to advise our customers. We support companies during drug development and throughout the drug’s product lifecycle by providing customized application and indication-based recommendations. We provide short-term platform solutions as well as product samples for early clinical studies. Gx Biological Solutions can also perform, evaluate, and interpret functional or laboratory tests as well as develop customized solutions for our customers.

About Nelson Labs
Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Nelson Labs serves over 3,800 customers across 15 facilities in the United States, Mexico, Asia, and Europe. We have a comprehensive array of over 800 laboratory tests supporting our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety, and quality assurance. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.
Based in Leuven, Belgium, Nelson Labs Europe specializes in providing premium extractables & leachables testing services to the pharmaceutical and medical device industries. We also support pharmaceutical companies across the globe in developing worldwide compliance testing strategies to qualify container/closure applications and pharmaceutical production equipment from an extractables & leachables perspective.
With decades of expertise, we stand behind the quality of our results and the strength or our customer partnerships. Along with our sister companies Sterigenics and Nordion, we are part of Sotera Health, the leading protector of global health.
Safeguarding Global Health® – with every test we complete. www.nelsonlabs.com