SMALL MOLECULE CONTRACT MANUFACTURING SERVICES
Awarded
The competition has ended and a winner has been selected.
- Deadline
- May 4, 2025Expired
- Award
- Submission of a manufacturing quality concept 35% and 1 more
Brief
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 and explora-tory tox/safety studies in preclinical animal models SCOPE2: process scale up to GMP manufacturing of drug substance and drug product to perform regulatory preclinical tox and safety studies (GLP compliant) as well as a GCP-compliant phase 1 first-in-human clinical trial for the sterile liquid dosage form and infusion administration SCOPE3: development of the semisolid dosage form for preclinical and phase 1 clinical administration via the topical route
Forsknings- og utviklingsvirksomhet og tilhørende konsulenttjenester
Result
- Ardena Holding N.V.Winner
- 3Number of bids
- €0Contract value
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Award Criteria
Description
Bidders are requested to submit a detailed Project Schedule covering the following aspects: * time planning * work packages/tasks; major deliverables * regulatory support * client communication The concept will be evaluated according to the following criteria: * completeness and depth of detail * quality of the proposed measures * conformity with quality requirements and relevant regulations Formal requirements: minimum 5, maximum 30 pages (excluding table of contents and cover page)
Source
No source found in the documents. Check the weight against the tender documents.
Description
Bidders are requested to submit a manufacturing quality concept covering the following aspects: * manufacturing track record (previous projects can be used as examples) * manufacturing sites, technical equipment and manufacturing processes * staff qualification and training * quality management measures The concept is evaluated according to the following criteria: * completeness and depth of detail * quality of the proposed measures * conformity with quality requirements and relevant regulations Formal requirements: minimum 4, maximum 10 pages (excluding table of contents and cover page)
Source
No source found in the documents. Check the weight against the tender documents.
Description
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 the score depending on the most favourable offer of the A_03_Price Schedule.xlsx.
Source
No source found in the documents. Check the weight against the tender documents.
Previous winners
Who are you up against?
The suppliers who have won similar contracts at Helmholtz-Zentrum für Infektionsforschung GmbH
From the notice
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 and explora-tory tox/safety studies in preclinical animal models SCOPE2: process scale up to GMP manufacturing of drug substance and drug product to perform regulatory preclinical tox and safety studies (GLP compliant) as well as a GCP-compliant phase 1 first-in-human clinical trial for the sterile liquid dosage form and infusion administration SCOPE3: development of the semisolid dosage form for preclinical and phase 1 clinical administration via the topical route
Contact
einkauf@helmholtz-hzi.de- ResultType
- Braunschweig, Kreisfreie StadtLocation
- 73100000Main codeResearch and experimental development services
- 33600000Pharmaceutical products