SMALL MOLECULE CONTRACT MANUFACTURING SERVICES
Buyer: Helmholtz-Zentrum für Infektionsforschung GmbH
- Published
- 17 February 2025
- Submission deadline
- 18 March 2025, 10:00
- Place of performance
- DE911
- Procedure
- Open procedure
- Lots
- 1
- Documents
- 1
- Notice number
- 00104746-2025
- Reference
- e699c4a8-d49d-47af-9fc8-8095a6304873
- Official source
- Official source
CPV codes
- 73100000Servicios de investigación y desarrollo experimental
- 33600000Productos farmacéuticos
Description
The headline objectives of the present manufacturing project are the use of the deliverables in GLP compliant preclinical toxicology and safety pharmacology studies as well as a phase 1 first-in-human clinical trial. The objective of the project is to manufacture two alternative pharmaceutical dosage forms, sterile liquid and semi-solid, to enable dosing as i.v. infusion and topical administration, respectively. This solely relates to current lack of clinical target validation and the requirement to ready the technology for proof-of-mechanism in systemic versus skin administration. We are targeting a virulence factor of S. aureus that may cause pulmonary or dermal infections. HZI wishes to commission the following activities under Master Service Agreement to a suited contractor. A Go/ NoGo milestone is set after scope 1 while the tendering process and resulting contract shall comprise SCOPE1, SCOPE2, and SCOPE3 activities so as to assure these can be offered in the most economical way in terms of price and quality from one legal entity. SCOPE1: process development and non-GMP manufacture of drug substance and injectable drug product to enable preclinical efficacy, pharmacokinetic…
Award criteria
- Price — Evaluation of price The criterion "price" is evaluated on the basis of the following points. The most favourable offer (lowest price) receives a score of 30. The prices of the other offers receive…
- Quality — Submission of a Project Schedule Concept Requirement and Evaluation Bidders are requested to submit a detailed Project Schedule covering the following aspects: • time planning • work…
- Quality — Submission of a manufacturing quality concept Bidders are requested to submit a manufacturing quality concept covering the following aspects: • manufacturing track record (previous projects can be…
Official publications
- TED · 00104746-2025 · 17 February 2025
- OJS · 33/2025 · 17 February 2025
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- SMALL MOLECULE CONTRACT MANUFACTURING SERVICES
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- Neubau HIRI (Helmholtz-Institut für RNA-basierte Infektionsforschung in Würzburg)
Frequently asked questions
- What is the deadline to bid for this tender?
- The submission deadline is 18 March 2025, 10:00. Check the official source, as dates can be modified.
- Who is the buyer of this tender?
- The contracting authority is Helmholtz-Zentrum für Infektionsforschung GmbH (European Union).
- How can I bid for public tenders in European Union?
- Bids are submitted through the official procurement portal of European Union. El Vínculo helps you find tenders and analyse their documents; submission always happens at the official source.
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