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Germany - Medical equipment, pharmaceuticals and personal care products - GMP production of antibacterial antibodies

Original Deutschland - Medizinische Ausrüstungen, Arzneimittel und Körperpflegeprodukte - GMP-Produktion antibakterieller Antikörper

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Key facts

Buyer
Universitätsklinikum Köln AöR
Where
Germany Köln
Procedure
Negotiated procedure The buyer selects candidates, then negotiates the offers before choosing. Full entry Above the EU threshold A contract large enough that EU-wide rules apply and it must be published on TED. Full entry
CPV code The EU's common vocabulary for what is being bought: an eight-digit code every notice carries. Full entry
33000000 Medical equipments, pharmaceuticals and personal care products 33651520 Immunoglobulins
Original language
German
Published
Source
via TED - Tenders Electronic Daily (Publications Office of the EU), verified 1 month ago
Notice number
858061-2025
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Summary

Machine-generated summary

The buyer is seeking a contractor to carry out the full GMP-compliant development of a monoclonal antibody against Pseudomonas aeruginosa up to providing a clinical trial preparation suitable for Phase I/II studies, covering both drug substance and drug product. Work includes feasibility assessment, development of a stable production cell line, creation of a GMP master cell bank, upstream and downstream process development, analytical method development and qualification, formulation, and stability, stress and in-use stability studies. Non-GMP and GMP batches must be produced with all required analytical testing, GMP documentation, release according to ICH/GMP requirements, and regulatory support documents (IMPD/CTA). Virus reduction testing, placebo manufacture and tissue cross-reactivity studies are optional. The entire process should be completed within about 18 to 24 months.

Description

Die Beschaffung umfasst die vollständige GMP-konforme Entwicklung eines monoklonalen Antikörpers bis zur Herstellung eines klinischen Prüfpräparats einschließlich Prozessentwicklung, Analytik, Formulierung und Produktion Der Auftrag umfasst die vollständige biopharmazeutische Entwicklung eines GMP-konformen monoklonalen Antikörpers gegen Pseudomonas aeruginosa bis zur Bereitstellung eines für Phase-I/II-klinische Studien geeigneten Prüfpräparats (Drug Substance und Drug Product). Der Auftrag beinhaltet u. a. die Herstellbarkeitsbewertung, die Entwicklung einer stabilen Produktionszelllinie, die GMP-konforme Erstellung eines Master Cell Banks, die Entwicklung und Optimierung von Upstream- und Downstream-Prozessen, die Entwicklung und Qualifizierung analytischer Methoden, die Formulierungsentwicklung sowie die Durchführung von Stabilitäts-, Stress- und In-Use-Stabilitätsstudien. Weiterhin umfasst die Beschaffung die Herstellung von nicht-GMP- und GMP-Chargen des Antikörpers einschließlich aller erforderlichen analytischen Prüfungen, der Erstellung der GMP-Dokumentation, der Freigabe gemäß ICH/GMP-Vorgaben sowie der Bereitstellung von Unterlagen zur regulatorischen Unterstützung (IMPD/CTA). Optional können Virusreduktionstests, Placeboherstellung und Tissue-Cross-Reactivity-Studien beauftragt werden. Der gesamte Entwicklungs- und Herstellprozess soll innerhalb eines Zeitraums von ca. 18-24 Monaten abgeschlossen werden.

Official source

Source: TED - Tenders Electronic Daily (Publications Office of the EU)

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Last verified against TED - Tenders Electronic Daily (Publications Office of the EU) 1 month ago

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More from this buyer

Full buyer profile

29 open tenders right now

This buyer has no award history in this sector yet. Usual winners, Medical equipment & pharmaceuticals - Germany

Company Wins Total awarded Last win
Siemens Healthineers AG 43 €20.0M Sep 2026
Philips GmbH 21 €7.2M Sep 2026
GlaxoSmithKline GmbH & Co. KG 15 n/a Aug 2026
ASTRAZENECA GMBH 13 n/a Jul 2026
Brainlab Sales GmbH 11 €4.9M Sep 2026

Based on 1053 awards with a linked company profile over the last 2 years.

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Market context

Avg. open tender · Medical equipment & pharmaceuticals
€11,447,367
10,065 open across Europe right now
Buyer track record on Aperlena
94 notices tracked · 15 awarded
€1,141,571 in awarded contracts

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