Request For Information – Supply of Boronophenylalanine for pharmaceutical preparation of compound for BNCT treatment

Kuvaus

Request For Information – Supply of Boronophenylalanine for pharmaceutical preparation of compound for BNCT treatment HUS Pharmacy is searching for a new supplier of L-4-boronophenylalanine (synonyms: BPA, borofalan, 4-(borono- 10B)-L-phenylalanine), CAS No [80994-59-8]. The supplied BPA will be used in pharmaceutical preparation of BPA-fructose complex used in BNCT-treatment at HUS Comprehensive Cancer Centre. The aim of this RFI is to survey and identify suppliers with the capability to manufacture BPA on a scale and according to the medicinal grade specifications set by HUS Pharmacy. After this RFI HUS Pharmacy will conduct a formal tendering process to establish a multi-year supplier contract. The estimated consumption of BPA is 2-4 kilograms per year starting from 2028. This number can change, as the accelerator based BNCT treatment is a novel process and thus under constant clinical study and development. The specifications for BPA are set out in Attachment 1 to this notice. We ask the interested parties to provide as much as possible of the following information: •Approximate minimum and maximum size of order in grams or kilograms, when delivery is from a single production batch. •Approximate time from order to delivery to Finland. We acknowledge that the production of BPA requires several months to complete. •Shelf-life of product from batch release. If provider has an ongoing stability program to extend the shelf-life, then the expected future shelf-life information can also be noted. •Description of the quality assurance of the final product and quality management of the production process. •Any possible regulatory requirements regarding HUS Pharmacy when delivering boron-10 isotope to Finland, if the providers national regulations have such requirements. •Information about other possible boron-10 carriers available for BNCT treatment can be provided. The information can be provided in a format of your choice in English or Finnish. Responses provided by suppliers will be treated confidentially. Interested party can send questions regarding the RFI to HUS Pharmacy with the initial information, and an active discussion can be arranged upon request. RFI can be supplemented based on the dialogue. This is not a contract notice or a request for tenders, but a request for information (RFI). The purpose of the RFI is to assess the market, identify suppliers currently operating in the market, and obtain information on their product portfolios. The RFI does not invite or request the submission of tenders, and this notice does not initiate a competitive tendering process. The information presented in this notice, as well as any information provided during the market consultation, is preliminary and indicative. HUS is under no obligation to proceed with the procurement or to adopt any procurement method. HUS will not pay any compensation for responding to the RFI or participating in the market consultation. Responding to the RFI does not oblige the supplier to participate in any subsequent competitive tendering process, nor is it a prerequisite for participating in any subsequent procurement procedure. Whether or not a supplier responds to the RFI will have no bearing on the supplier’s position in any subsequent competitive tendering process.,

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