EVREA-Phage

Development of early manufacturing processes and production of bacteriophages, ideally up to the clinical trial material.

Hauptort der Ausführung: Leibniz Institute DSMZ-German Collection of Microorganisms and Cell Cultures GmbH Inhoffenstr. 7 B 38124 Braunschweig

The services are divided into two phases, which will be awarded simultaneously to the same bidder.

Phase 1: The client works on the characterization of bacteriophages and the composition of a phage cocktail directed against Enterococcus faecium for an oral application. The cocktail will consist of four individual, well-characterized phages and aims for the intestinal VRE and VRE+ decolonization in immunocompromised patients. In this context the customer is looking for a service provider located in the EU that can offer the early process development and production of non-GMP bacteriophages. The procurement also includes the development and implementation of analytical methods, the production of a research cell bank, a research phage seed and the development of the upstream and downstream processes.

Phase 2: This phase includes the development of the subsequent GMP manufacturing process, the chemistry, the control activities and the production of clinical trial material (oral administration) for the clinical phase I trials planned for 2026. Phase 2 is subject to the reservation of financing, i.e. the corresponding services will only be called off by the client if the client for his part receives the corresponding funds and orders phase 2 separately from the contractor in writing. The funding reservation depends on the cost-related result of the EU tender for phase 2. The client in turn applies to the sponsor for the funds for phase 2. In addition, the funding reservation for phase 2 depends on whether suitable bacteriophages can be found in phase 1 and on what effect is shown in the translational mouse model. Until the end of the project (December 31st, 2026) the contractor is bound by the conditions offered for phase 2. The contractor is not entitled to the services for phase 2, and without a separate order for phase 2 also has no right to payment for phase 2.

Beschreibung der Optionen:

Anzahl der eingegangenen Angebote von KMU: 0

Anzahl der elektronisch eingegangenen Angebote: 1

1) The tender documents are available until the specified date for unrestricted and complete direct access free of charge on the award platform at the Internet address stated under I.3. No paper copies will be sent out.

2) The awarding authority points out that, in order to ensure a speedy procedure, only bidder inquiries received by the awarding authority in due time and via the awarding platform can be answered.

3) Questions regarding the tender documents must be submitted in writing and without delay after they become known, but no later than 7 days before the expiry of the deadline for submission of bids (see IV.2.2) via the Internet address stated under I.3.

4) Binding answers shall be published as "Bidders' questions/specifics" in the tender documents at the Internet address specified in Section I.3 up to 6 days before the expiry of the deadline for submission of bids.

5) The specifics shall become part of the award documents and shall thus form an integral part of the contract. They must be enclosed with the electronic bid supplemented by the information requested from the bidder.

6) Legal form of/ requirement for bidding consortia: Bidding consortiums must submit a declaration of all members in text form with the bid. At the request of the contracting authority, a declaration signed or advanced or qualified signed by all members must be submitted. Multiple bids by individual bidders and/or bidders as members of one or more bidding consortia are not permitted and will automatically result in exclusion. It is recommended that the bidding consortium declaration be submitted with the bid. A bidding consortium declaration that is not fully completed or signed, even upon request, will result in the mandatory exclusion of the bid.

If you intend to participate in our award procedures, we recommend that you register free of charge with the subreport ELViS award platform, as otherwise we cannot guarantee the complete and transparent transmission of information. Non-registered participants are obligated to independently inquire about changes to the award documents and possibly provided information (answers to bidders' questions, date and deadline changes) regarding the respective procedures at the awarding authority.

Assistance on the application and use of the subreport ELViS award platform is available at https://www.subreport.de/service/support-elvis/ and directly in the application.

Information on the requirements for the use of electronic means in award procedures (in accordance with §11, Para. 3 VgV) is available at the following location:

Data protection: see data protection notice HZI (enclosed with the award documents) that must be signed by the bidder.

Genaue Angaben zu den Fristen für die Einlegung von Rechtsbehelfen: