Our location
Geleen – new mRNA/LNP services and manufacturing
At our site in Geleen, Lonza operates cell and gene therapy process development and manufacturing, mRNA/LNP process and analytical development labs, as well as clinical cGMP capabilities. The facility includes more than 30,000 square feet of laboratory, cGMP manufacturing and office space. The expansion supports the manufacturing of non-GMP product suitable for formulation development and toxicology studies, as well as cGMP product for early and late-stage clinical trials. The expanded development services at the Geleen (NL) site are available with cGMP readiness scheduled in the first quarter 2024.
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Regulatory expertise
Pathway to success in Regulatory filings
Extensive Regulatory Expertise
We offer our in-depth expertise in the interpretation of legal requirements and guidance in innovative and emerging markets. Our regulatory affairs CMC experts are co-located alongside subject matter experts at our manufacturing sites around the globe. Our team has extensive experience in CMC dossier writing as well as preparing responses to questions from health authorities across the world.
Dedicated Regulatory Affairs Contact
We ensure that each project has one dedicated regulatory affairs point of contact who, in partnership with you, will develop and finalize a regulatory CMC strategy. The strategy will ensure you have the required data to support global applications.
Keep Pace with Regulatory Thinking
Our Regulatory Affairs Services prioritize transparent communication. We ensure that you are continuously informed from kick-off and during subsequent interactions, facilitating any CMC development strategy or detailed discussions.