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PDC*line Pharma is GMP accredited by the Belgian Federal Agency for Medicines and Health Products (FAMHP) for its Quality Control and Release Activities for PDC*lung, a drug for lung cancer immunotherapy
11Feb2019
Liège
(Belgium), 21st January 2019. PDC*line Pharma is delighted to announce, that
the company is now accredited by the Belgian Federal Agency for Medicines and
Health Products (FAMHP) for the Quality Control and Release activities of its
anticancer agent PDC*lung, intended for the treatment of patients with lung
cancer.
PDC*line
Pharma is developing a new range of therapeutic anti-cancer vaccine using its
versatile PDC*vac platform. This platform uses a plasmacytoid dendritic cell
line (PDC*line) which can prime and strongly expand anti-tumor T lymphocytes
against any tumorous antigen.
More specifically, this accreditation allows the company to release its batches of PDC*lung vials for treatment of patients, with quality controls ensured by laboratories located at the LabHotel of GIGA (Institute for Interdisciplinary Research in Biomedical Sciences of the University of Liège).
Since the
beginning of 2017, PDC*line Pharma has developed in Liège a Research and
Development and Quality Control activity of its innovative therapies within the
GIGA LabHotel. The quality control analyses carried out in Liège are based on
flow cytometry for identity, purity and safety, and on bioassays for the
functionality of the product.
PDC*line
Pharma has successfully passed the inspection of the FAMHP. The Agency
inspector commented that PDC*line Pharma met the standards of Good
Manufacturing Practice (GMP) for GIGA facilities, and for quality control
activities related to the PDC*lung product.
This step
is a great stride in PDC*line Pharma journey, and supports the rapid progress
leading the Phase I / II clinical study, PDC-LUNG-101, expected to start
enrolling patients in the 1st half of 2019.
Liège (Belgium), 21st January 2019. PDC*line Pharma is delighted to announce, that the company is now accredited by the Belgian Federal Agency for Medicines and Health Products (FAMHP) for the Quality Control and Release activities of its anticancer agent PDC*lung, intended for the treatment of patients with lung cancer. PDC*line Pharma is developing a new
The Medical Simulation Center of the University of Liège organizes its first congress in Health Simulation: “Towards evidence-based simulation”. Event will be held on Thursday, March 28th, 2019 in the faculty of medicine amphitheatres of Liège University, located on Sart-Tilman campus. Several themes will be discussed: Evidence-based Innovations and advances in simulation Medical education –
The Clinical Sciences Department of the Medicine Faculty of the University of Liège organizes from the academic year 2018-2019 a University Certificate in clinical trials. More information is available in this folder