EVREA-Phage
Auftragsbekanntmachung
Dienstleistungen
Abschnitt I: Öffentlicher Auftraggeber
Nationale Identifikationsnummer: 054_004_2023
Postanschrift:[gelöscht]
Ort: Braunschweig
NUTS-Code: DE911 Braunschweig, Kreisfreie Stadt
Postleitzahl: 38124
Land: Deutschland
E-Mail: [gelöscht]
Telefon: [gelöscht]0
Internet-Adresse(n):
Hauptadresse: https://www.helmholtz-hzi.de
Abschnitt II: Gegenstand
EVREA-Phage
Development of early manufacturing processes and production of bacteriophages, ideally up to the clinical trial material.
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.
Phase 2 is subject to the condition of financing and to a separate Phase2-order (cf. II.2.4 above)
Abschnitt III: Rechtliche, wirtschaftliche, finanzielle und technische Angaben
• General Terms and Conditions of the HZI Purchasing Department, “Einkaufsbedingungen”
• Anti-corruption clause, “Antikorruptionsklausel”
• Declaration on taxes and social security contributions, as well as existing or impending bankruptcy proceedings, “Steuern, Abgaben, Insolvenz, etc”
• Data protection notice, “Datenschutzhinweise”
• Self-declaration of the applicant, “Eigenerklärung”
• Self-declaration_RUS_Sanctions_Art_5k
By written statement: the manufacturer must be able to demonstrate experience in the production of several different phage-based drugs for clinical trials. The provider must be able to show a sustainable/ profitable track record in the contract development and manufacturing space, e.g. reference to public domain or contact references.
• By certificate: Proof of compliance with local legal requirements for manufacture of an API for an Investigational Medicinal Product to be used in clinical trials phase I-III according to current EU legislation (Regulation (EU) No 536/2014), e.g. Manufacturing Authorization according to § 13 (1) AMG. Candidates are also accepted that comply with cGMP standards and commit to obtain the required manufacturing authorization on a timeline acceptable for the clinical trial material production. There is the regulatory requirement that the material used in preclinical studies must not vary much from the subsequent IMP material for clinical studies.
• Proof of registration in a public register (e.g. commercial or trade central register; not older than three months) or comparable.
• Proof of an existing business/professional liability insurance policy
• By written statement: availability of the main bioreactor >=20 L, preferable up to 200 L, and adequate USP and DSP equipment.
• By certificate or written statement: Environmental management system (for example EMAS)
The entire process will be awarded to the CMO as a phased contract and must run sequentially after successful completion of each work package. A Master Service Agreement (MSA) will be signed to facilitate the commission of the required work packages. There will be a commercial agreement and an additional quality assurance agreement.
It is expected to have acceptable waiting times for room and equipment bookings to avoid delays in the timelines. The main delivery of the procurement is to establish a robust quality manufacturing process of the API that is upscaled to >=20 L for the subsequent GMP manufacturing.
Work packages must include:
• Development and implementation of analytical methods
• Production of a research cell banks (RCB) including relevant tests and studies for the release
• Research phage banks/seeds (RPS) including relevant tests and studies for the release
• Development of the API manufacturing process, including upstream (USP) and downstream (DSP) processes
• The aim of the early process development is to establish a robust quality manufacturing process of the API that is upscaled to >=20 L for the subsequent GMP manufacturing
Phase 2 includes the continuation of the early development services of the procurement up to the formal GMP manufacturing process up to the manufacturing of clinical trial material to fulfill the regulatory requirements that the quality of pre-GMP and GMP material are comparable. Additionally, the transition from early process development to GMP manufacturing must go hand in hand to avoid a time consuming transfer to a different CMO and to benefit from the knowledge and experiences gained from the early process development.
The GMP activities include the following:
• Production of a master cell bank
• Master phage seed
• Chemistry, manufacturing and control activities
• Technical runs
• Engineering runs
• GMP runs to gain the drug substance (API)
• Manufacturing of clinical trial material, drug product/ oral formulation
• GMP of placebo
• CMC documentation for IND filing
Abschnitt IV: Verfahren
Abschnitt VI: Weitere Angaben
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:
https://www.subreport.de/wp-content/uploads/2011/06/Zusammenfassung-%C2%A7-11-VgV-Abs.-3.pdf
Data protection: see data protection notice HZI (enclosed with the award documents) that must be signed by the bidder.
Postanschrift:[gelöscht]
Ort: Bonn
Postleitzahl: 53123
Land: Deutschland
Telefon: [gelöscht]
Fax: [gelöscht]
Internet-Adresse: http://www.bundeskartellamt.de/SharedDocs/Kontaktdaten/DE/Vergabekammern.html
Precise information on deadline(s) for review procedures:
The award procedure is subject to review in a review procedure pursuant to section 155 et seq. of the "act against restraints of competition" (GWB “Gesetz gegen Wettbewerbsbeschränkungen”). The competent procurement chamber shall initiate review proceedings only upon application (section 160 (1) GWB). An application for review is inadmissible pursuant to section 160 (3) sentence 1 GWB insofar as:
1. the applicant has recognized the asserted infringement of procurement regulations prior to submitting the application for review and has not objected to it towards the contracting entity within a period of ten calendar days; the expiry of the period pursuant to section 134 (2) shall remain unaffected,
2. violations of procurement regulations which are apparent from the notice are not notified to the contracting entity until the expiry of the period for application or submission of bids specified in the notice,
3. violations of procurement regulations which are only recognizable in the award documents are not notified to the contracting entity at the latest by the expiry of the period for application or submission of bids,
4. more than 15 calendar days have elapsed since receipt of the contracting entity's notification that it does not intend to remedy a complaint.
The contracting authority is obliged to send a bidder information at the latest 10 days before the award of the contract (Section 134 GWB).
After the award of the contract (signing of the contract), an application for review is no longer admissible. Exceptions to this are applications for a declaration that the contract is invalid pursuant to Section 135 (1) GWB, i.e. due to a breach of the aforementioned obligation to inform the bidder and compliance with the waiting period pursuant to Section 134 GWB or due to an inadmissible award without prior publication of a notice in the Official Journal of the EU. According to Section 135 (3) GWB, such applications for a declaration of invalidity of the contract are only admissible within 30 calendar days after the contracting authority has informed the bidders and candidates concerned about the conclusion of the contract, but not later than six months after the conclusion of the contract. If the contracting authority has published the award of the contract in the Official Journal of the European Union, the period for asserting invalidity ends 30 calendar days after publication of the notice of this award in the Official Journal of the European Union.
Postanschrift:[gelöscht]
Ort: Braunschweig
Postleitzahl: 38124
Land: Deutschland
E-Mail: [gelöscht]
Telefon: [gelöscht]0
Internet-Adresse: https://www.helmholtz-hzi.de/de/