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
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
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.
