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Lonza Walkersville, Inc. in Maryland is a cGMP/GTP compliant clinical cell processing facility, engineered with exceptional quality in mind and designed specifically to meet the needs of our cell therapy clients. The suites currently include ISO Class 7 (Class 10,000) to meet US requirements and will soon include ISO Class 5 (Class B) for European needs. Ranging in size from 275 to 1,000 square feet, they are designed with a flexibility that permits us to configure the suites to meet unique customer needs.
Features include:
- unidirectional flow design for materials and personnel;
- dedicated QC suite;
- redundant power systems;
- independent air handling systems;
- validated and remotely alarmed equipment;
- excellent technical and support staffs;
- adequate space for expansion into commercial production scale.
This facility is an established FDA Registered Tissue Bank, and is ISO 9001:2000 Registered and ISO 13485 - Medical Devices Registered.
We also have a state-of-the-art clinical cell processing facility in Verviers, Belgium. Both EU and cGMP complaint, it has been inspected and approved by the Belgium Authority for cell therapy manufacturing, and is FDA Registered.
The facility features:
- unidirectional flow of materials and personnel;
- round the clock environmental monitoring;
- validated and remotely alarmed equipment;
- dedicated QC suite;
- multiple walk-in incubator rooms;
- space for expansion to commercial scale production.
For more information about our facilities, please click here.
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