Licenses

- Lonza Netherlands B.V. -

With an approved IMPD, Lonza Netherlands can produce your product for Europe! No product specific licenses for clinical trial programs are needed in The Netherlands.

Lonza Netherlands is qualified for commercial production following MAA product approval and EMA inspection. Our facility holds all licensures for manufacturing under GMP conditions for Advanced Therapeutic Medicinal Products (ATMPs) registered under Investigational Medicinal Product Dossier (IMPD) for the European market.

Lonza Netherlands maintains a cGMP compliant quality system and all documentation is in English.

This means that any product from any client can be GMP manufactured for clinical studies under this license and no separate license per product is required as long as an approved IMPD is provided to Lonza Netherlands.

GMP Certification CMF Geleen

The Geleen Cell Manufacturing Facility was first GMP certified in 2012 by the Dutch authorities (IGZ).

Fact sheet

GMP Certification CMF Maastricht

Our Maastricht Cell Manufacturing Facility was first GMP certified in 2006 and has been successfully inspected by the Dutch Authorities (IGZ) on a regular basis thereafter.

Fact sheet