SMALL MOLECULE CONTRACT MANUFACTURING SERVICES

Stammdaten

Auftraggeber

Helmholtz-Zentrum für Infektionsforschung GmbH, Braunschweig

Veröffentlicht

16.02.2025

Frist (Submission)

18.03.2025

Notice-Typ

Ausschreibung

Verfahrensart

Offenes Verfahren

CPV-Code

73100000 — Forschung und Entwicklung

Branche

Gesundheitswesen & Medizintechnik

Rechtsgrundlage

EU-Oberschwelle

Beschreibung

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

Vertragslaufzeit

Periode

4 Jahre

Verlängerungsoption

bis zu 2× verlängerbar

Verfahrens-Bedingungen

Bindefrist

3 Monate

Verfahrensverlauf — alle 2 Veröffentlichungen

• Ausschreibung · Frist: 18.03.2025
• Vergabeergebnis

Zuständige Vergabekammer (laut Bekanntmachung)

Vergabekammer des Bundes, Bonn

Angabe aus der TED-Bekanntmachung. Im Streitfall ist die tatsächlich zuständige Vergabekammer nach §§ 155 ff. GWB maßgeblich, nicht zwingend die hier genannte.