Operational Expertise

- PharmaCell B.V. -

Production

  • GMP-compliant manufacturing in open & closed cell processing
  • Experience with autologous & allogeneic manufacturing
  • Patient specific dosing
  • Project-dedicated teams with training specific for client’s manufacturing process

Quality Control

  • GMP-compliant safety, identity testing, flow cytometric analysis, functional assays
  • Experience with QC method transfer & Validation of QC tests
  • Secured Chain of Identity
  • In-house Endotoxin, Myco-alert, Bioburden, FACS analysis, ELISA testing
  • Raw material in-house testing prior to release

 Quality Assurance

  • Real-time release
  • Qualified Persons in-house
  • QA release and QP certification for European Market
  • Support for IMPD- and MAA submissions
  • Supplier Qualifications

 Engineering

  • GMP compliant validation & maintenance of equipment
  • Maintenance of Utilities & Building Management System
  • Handling incoming alarms & alarm reporting
  • Breakdown maintenance, 24 hour support

 

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