Public procurement notice: Voluntary Ex Ante Transparency Notice
Published: 2022-11-02
Buyer: SYKEHUSINNKJØP HF
Country: NO
Contract type: Supplies
Procedure: Contract award without prior publication
CPV classification: 33000000 | 38000000
Estimated value: 3700000 NOK

Technical requirements: Laboratory equipment, bioreactor for the preparation of an advanced cell therapy product for Bergen Hospital Trust
Sykehusinnkjøp intends, on behalf of Bergen Hospital Trust, to enter into a procurement contract with Miltenyi Biotec for the instrument CliniMACS Prodigy for the Ex-vivo facility (classified clean room) in the Immunology and Transfusion Medicine Department (AIT) at Haukeland University Hospital.
There is already a CliniMACS Prodigy instrument in a laboratory on the 5th floor in the laboratory building. This instrument is used for the establishment of protocols for the production of a cell product (medicine) for use in clinical studies. When these protocols have been established, the production processes will be able to reproduced on an equivalent instrument (in order to manufacture an equivalent product) in the Ex-vivo facility, in laboratory premises that have been approved by the Norwegian Medicines Agency for the treatment of patients. In order to carry out the same production process, and get the same yield/final product, it is a prerequisite that the instrument used for the production process is the same in both the preclinical protocol and the clinical protocol. I.e., the production process that is carried out in the Ex-vivo facility, where the procured instrument will be placed, must be carried out so it produces the same final product as shown in the preclinical studies.
Based on this conditions a call for tenders cannot be implemented and the terms in the Public Procurement Regulations' § 13-4 first section, letter b, no. 2 are therefore fulfilled.
There is already a CliniMACS Prodigy instrument in a laboratory on the 5th floor in the laboratory building. This instrument is used for the establishment of protocols for the production of a cell product (medicine) for use in clinical studies. When these protocols have been established, the production processes will be able to reproduced on an equivalent instrument (in order to manufacture an equivalent product) in the Ex-vivo facility, in laboratory premises that have been approved by the Norwegian Medicines Agency for the treatment of patients. In order to carry out the same production process, and get the same yield/final product, it is a prerequisite that the instrument used for the production process is the same in both the preclinical protocol and the clinical protocol. I.e., the production process that is carried out in the Ex-vivo facility, where the procured instrument will be placed, must be carried out so it produces the same final product as shown in the preclinical studies.
Based on this conditions a call for tenders cannot be implemented and the terms in the Public Procurement Regulations' § 13-4 first section, letter b, no. 2 are therefore fulfilled.
Objections to the intention to sign a contract must be directed to Sykehusinnkjøp, c/o consultant Jessica H. ONeil by 07.11.2022.


Winner: Miltenyi Biotec Norden AB
Award value: 3700000