Fact sheet

- Lonza Netherlands BV -

GENERAL

Company

Lonza Netherlands B.V., Maastricht (The Netherlands)

Lonza Geleen B.V., Geleen (The Netherlands)

Founded 2005
Location Airports nearby Centrally in Europe, The Netherlands Maastricht (NL) Brussels (B, 1 hr), Cologne (D, 1 hr), Dusseldorf (D, 1 hr), Amsterdam (NL, 2 hr)
Number of Employees 70, 14 nationalities
Departments Lay-Out Team QA, QC, Manufacturing, Engineering, PD&R and PM
Design Core team with member from every department

GENERAL BUSINESS STRATEGY

General Description CMO, GMP Manufacturing of Cell Therapy Products
License GMP license for ATMPs since 2006

SERVICES

Process Research & Development Experience with automation: Continuous flow centrifugation & bioreactor systems
Project Management Efficient Technology Transfer system in place
Incoming Logistics Dedicated courier system. Assistance in patient manufacturing scheduling
Incoming Goods Ensure in-time handling of short shelf life cell materials
Manufacturing

Manufacturing Autologous & Allogeneic products

Master- and Working Cell Bank generation, Drug Substance and Drug Product

Focus on aseptic handling program for real-time-release

Manufacturing Autologous & Allogeneic products
Quality Control Secured Chain of Identity, validated safety, identity & potency assays
Final Formulation Patient specific dosing / Dose escalation studies
Release Real-time batch review & release of fresh products
Outgoing Logistics Dedicated courier system for transport to clinical site
Validated transport system for fresh & frozen products

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