Cell Therapy Manufacturing

Lonza's Walkersville facility is located in northern Maryland approximately 50 miles north and west of Washington, DC.  This manufacturing site 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. Our state-of-the-art manufacturing suites currently include ISO Class 7 (Class 10,000) which are designed to meet US regulatory requirements as well as ISO Class 5 (Class B) suites designed for European regulatory needs. Ranging in size from 275 to 1,000 square feet, each suite is designed with complete flexibility in order to allow us to configure the suites to meet our customer's unique 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.

 

The Walkersville facility is an established FDA Registered Tissue Bank, and is ISO 9001:2000 Registered and ISO 13485 - Medical Devices Registered.