The Department of Medical BioSciences from Radboudumc has been award a KWF grant for the PROTECT-lynch study. The main goal of the PROTECT-lynch study is a new treatment option for LS patients significantly improving the quality of life of LS patients and most likely the prognosis (occurrence of Lynch-related cancer(s). Standard care for healthy LS patients currently consists of undergoing intensive surveillance programs that do not guarantee timely detection of one or more Lynch-related cancers at a treatable stage. The PROTECT-lynch study may change this with its preventive dendritic cell therapy. To prepare the intended dendritic cell (DC) product for the PROTECT-lynch study, several different short GMP peptides are required in drug substance (Active Pharmaceutical Ingredient, API) quality. As the Medical BioSciences department, we have extensive experience in the preparation of DC products in collaboration with the Pharmacy department, in which comparable peptides were present as important active substances. The specific peptides are always selected based on suitable targets in the intended patient population for which the treatment is being developed. In the case of the PROTECT-lynch study, a comprehensive screening analysis was conducted to identify common gene mutations and their occurrence rates in tumors among a broad patient group with Lynch-related cancers, categorized by HLA type. The selected tumor-specific peptides, so-called neoantigens, were then ordered from research-grade biotech companies and used at the research lab in T cell induction and expansion assays to verify that the targeted specific T cells could be generated and expanded in vitro. In addition, cytotoxicity assays were performed to determine whether the selected tumor-specific peptides could be presented by dendritic cells to T cells in the corresponding HLA type. For this extensive project the Medical BioSciences department is looking for a reliable supplier of custom-made GMP peptides in API quality in the requested quantities, incl. execution of stability studies per peptide according to ICH guidelines and strict timelines. This manufacturer must hold a GMP API manufacturing certificate and have their production facility in Europe. The custom-made GMP peptides that will be used in the PROTECT-lynch study (phase I/II) are expected to be utilized in a large-scale follow-up study (phase III). It is crucial for us that the supplier, who is going to accept the assignment of the custom-made GMP peptides, is reliable (able to meet agreed timelines and fulfill the assignment).

See tender documents as included in Source-to-Contract (Mercell) and/or contact the responsible procurement advisor.

The Department of Medical BioSciences from Radboudumc has been award a KWF grant for the PROTECT-lynch study. The main goal of the PROTECT-lynch study is a new treatment option for LS patients significantly improving the quality of life of LS patients and most likely the prognosis (occurrence of Lynch-related cancer(s). Standard care for healthy LS patients currently consists of undergoing intensive surveillance programs that do not guarantee timely detection of one or more Lynch-related cancers at a treatable stage. The PROTECT-lynch study may change this with its preventive dendritic cell therapy. To prepare the intended dendritic cell (DC) product for the PROTECT-lynch study, several different short GMP peptides are required in drug substance (Active Pharmaceutical Ingredient, API) quality. As the Medical BioSciences department, we have extensive experience in the preparation of DC products in collaboration with the Pharmacy department, in which comparable peptides were present as important active substances. The specific peptides are always selected based on suitable targets in the intended patient population for which the treatment is being developed. In the case of the PROTECT-lynch study, a comprehensive screening analysis was conducted to identify common gene mutations and their occurrence rates in tumors among a broad patient group with Lynch-related cancers, categorized by HLA type. The selected tumor-specific peptides, so-called neoantigens, were then ordered from research-grade biotech companies and used at the research lab in T cell induction and expansion assays to verify that the targeted specific T cells could be generated and expanded in vitro. In addition, cytotoxicity assays were performed to determine whether the selected tumor-specific peptides could be presented by dendritic cells to T cells in the corresponding HLA type. For this extensive project the Medical BioSciences department is looking for a reliable supplier of custom-made GMP peptides in API quality in the requested quantities, incl. execution of stability studies per peptide according to ICH guidelines and strict timelines. This manufacturer must hold a GMP API manufacturing certificate and have their production facility in Europe. The custom-made GMP peptides that will be used in the PROTECT-lynch study (phase I/II) are expected to be utilized in a large-scale follow-up study (phase III). It is crucial for us that the supplier, who is going to accept the assignment of the custom-made GMP peptides, is reliable (able to meet agreed timelines and fulfill the assignment).

See tender documents as included in Source-to-Contract (Mercell) and/or contact the responsible procurement advisor.