IDM opens cGMP facility
IDM (Immuno-Designed Molecules), a biopharmaceutical company specialised in immunotherapy for the treatment of cancer, has opened its first cGMP production centre in the United States, based at its North American facility in Irvine, California.
IDM (Immuno-Designed Molecules), a biopharmaceutical company specialised in immunotherapy for the treatment of cancer, has opened its first cGMP production centre in the United States, based at its North American facility in Irvine, California.
The centre will be dedicated to the production of cell drugs intended for IDM sponsored clinical trials in North America.
The IDM facility has received a Drug Manufacturing License from the State of California Department of Health Services, which allows IDM to produce cell drugs for therapeutic clinical trials. The site is equipped to handle the complete cell drug manufacturing process, from the receipt of cells following their removal from a patient's blood, to cell processing and freezing, storage and shipment of the final product back to hospitals participating in the clinical trial.
The first products being prepared in Irvine are for the clinical trial utilising Collidem, IDM's product candidate to treat colorectal cancer. The production process began in January 2004.
Collidem is a therapeutic vaccine made up of the patient's dendritic cells combined with a combination of selected peptides present on the cancer cells.
'Following the IND (Investigational New Drug) approval we received from the FDA in late 2003 for this clinical trial in colorectal cancer, this certification of our production center in Irvine by the State of California constitutes a significant step in our development in the United States,' said Jean-Loup Romet-Lemonne, president and ceo of IDM. 'We are now able to produce our cell drugs in North America as well as Europe thanks to our cGMP centres in Irvine and Paris,' he added.