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TED - Tenders Electronic Daily (Publications Office of the EU) verified 1 week ago Contract notice

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

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

Closed Germany Köln Medical equipment & pharmaceuticals

Buyer Universitätsklinikum Köln AöR

Key facts

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  1. Published
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Summary

Machine-generated summary

The procurement covers the complete biopharmaceutical development of a GMP-compliant monoclonal antibody against Pseudomonas aeruginosa through to supplying a clinical trial drug suitable for Phase I/II studies, comprising both Drug Substance and Drug Product. Work includes feasibility assessment, development of a stable production cell line, GMP creation of a Master Cell Bank, upstream and downstream process development and optimisation, development and qualification of analytical methods, formulation development, and stability, stress and in-use stability studies. The contract also covers production of non-GMP and GMP batches with all required analytical testing, GMP documentation, release under ICH/GMP requirements and regulatory support documents (IMPD/CTA). Virus reduction testing, placebo manufacture and tissue cross-reactivity studies are optional. The full process should be completed within approximately 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 week ago

Universitätsklinikum Köln AöR

Germany

notices in the register
146
awards
27
awarded in total
€1.1M

Who wins its contracts

Many suppliers
different companies won its awards
21
of the awards went to the three most frequent winners
22%
of its calls state an estimated value
0%

Based on 23 awards with a named winner over the last 3 years. Counted by award, not by value, because lot and framework amounts are not comparable. Concentrated means the three most frequent winners took 65% or more of the awards; many suppliers, under 35% with at least ten different winners.

Competition

tenders per lot on average (open and restricted procedures)
4.5
of those lots received a single tender
9%
of the awards went to companies based in another country
9%

As the official award notices state them, over the last 3 years. Tenders per lot count open and restricted procedures only: in a negotiated procedure or a direct award a single tender is the procedure itself. The country is the one the notice gives for the winner.

One dot per award, on the day it was signed, sized by its value. A ring is an award with no published value.

Awards most often to

  1. Dedalus HealthCare GmbH 3 awards
  2. Cytiva Europe GmbH 1 award €496,693
  3. CH Consult GmbH 1 award €335,740

11 open tenders right now

Market context

open now in Medical equipment & pharmaceuticals
8,192
median open notice
€303,562

Who wins in this market

Many suppliers

Germany · Medical equipment & pharmaceuticals

different companies won awards here
806
of the awards went to the three most frequent winners
9%
buyers awarded contracts here
447

Based on 1,527 awards with a named winner over the last 3 years. Counted by award, not by value, because lot and framework amounts are not comparable. Concentrated means the three most frequent winners took 65% or more of the awards; many suppliers, under 35% with at least ten different winners.

Competition

tenders per lot on average (open and restricted procedures)
12.2
of those lots received a single tender
16%
of the awards went to companies based in another country
7%
of the tenders came from another country
6%

As the official award notices state them, over the last 3 years. Tenders per lot count open and restricted procedures only: in a negotiated procedure or a direct award a single tender is the procedure itself. The country is the one the notice gives for the winner.

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