Summary
Machine-generated summaryThe 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
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
The buyer
Full buyer profileUniversitätsklinikum Köln AöR
- 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
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Market context
- open now in Medical equipment & pharmaceuticals
- 8,192
- median open notice
- €303,562
Who wins in this market
Many suppliersGermany · 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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