PharmaCell has experience with manufacturing Clinical Trial Material in Phase I to Phase III clinical trials. Next to clinical trial manufacturing, PharmaCell is also equipped to support and manufacture for your commercial cell therapy product for Europe.
CHALLENGES in the C ell Therapy Industry relate to high variability:
Incoming material is obtained from patients or cell material. Parameters will vary.
Raw materials used in the manufacturing are not always GMP compliant. Batch-to batch consistency needs to be tested on the right cell type.
Variance in patient treatment schedules requires real-time manufacturing
Project specific QC assays demand deep cell biological knowledge
PharmaCell solely focuses on Cell Therapy Manufacturing and brings experience with autologous and allogeneic manufacturing for clinical programs for clients to bring SOLUTIONS in the design of the clinical program:
Assist in the design of training for and qualification of tissue collection sites
Ensure batch-to batch consistency by setting correct parameters for incoming cell material
Identify and deal with critical steps and materials in the full manufacturing supply chain in support of your clinical study
Have teams ready for real time manufacturing in line with the rate of patient recruitment
Ensure succesful real-time batch release due to intense operator qualification training & environmental trending
GMP Certification CMF Geleen
The Geleen Cell Manufacturing Facility was first GMP certified in 2012 by the Dutch authorities (IGZ).