Public procurement notice: Contract Award Notice
Published: 2025-05-07
Buyer: Helmholtz-Zentrum für Infektionsforschung GmbH
Country: DE
Region: DE911
Contract type: Services
Procedure: Open procedure
CPV classification: 33600000: Pharmaceutical products | 73100000
Estimated value: 0.01 EUR
Award criteria: price, quality

Technical requirements: 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
The place of performance refers only to the delivery service. The place of manufacture shall be the bidder's place of business.
Evaluation of price 
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.

Formula (price) = 30 * (most favourable offer / offer under consideration)
Submission of a Project Schedule
Concept Requirement and Evaluation

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)

Time planning (30 points)	
25 - 30 points	Very good	Conclusive, realistic and flexible planning with sensible milestones and buffer times.
17 - 24 points	Satisfactory	Basic scheduling with minor ambiguities or insufficient adaptability.
0 - 16 points	Poor	Unclear, unrealistic planning without buffer times and dependencies.

Project structure & tasks (30 points)	
25 - 30 points	Very good	Clear, logical distribution of tasks with sensibly linked deliverables.
17 - 24 points	Satisfactory	Basic structure in place, but with ambiguities in tasks or dependencies.
0 - 16 points	Poor	Illogical, incomplete task structure with missing deliverables.

Regulatory support (20 points)	
16-20 points	Very good	Support with IMPD writing (DS&DP sections)
8-15 points	Satisfactory	Support in answering regulatory questions (e.g. analytical methods)
0-7 points	Poor	Little to no support

Client communication (20 points)	
16 - 20 points	Very good	Clear reporting channels and communication structures with systematic documentation.
8 - 15 points	Satisfactory	Communication available, but not always clear or consistent.
0 - 7 points	Poor	Missing or inadequate communication structures and reporting channels.

Overall rating (100 points)
-	Coherent and comprehensive concept that meets high standards.
-	Solid planning with optimization potential in individual areas.
-	Incomplete or impracticable concept with unfulfilled requirements.

Quality evaluation
The criterion "quality" is evaluated based on the following documents:
B_02_Submission of a Project Schedule 
B_03_Submission of a manufacturing quality concept

A maximum of 100 points can be achieved for the Project Schedule, representing a maximum of 35% of the quality score.

Formula (quality per concept) = 35 * (bidder´s concept / 100)
Submission of a manufacturing quality concept
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)

Evaluation scheme:
manufacturing track record  (25 points)	
20 - 25 points	Very good	Coherent, detailed and methodical approach; successful production implementation proven through quality assured implementation. (Refer to projects already completed)
12 - 19 points	Satisfactory	Solid approach, but not consistently convincing; track record in manufacturing partly recognizable, but not specific enough.
0 - 11 points	Poor	Inadequate approach, vague description, no realistic implementation, no visible track record in manufacturing. 

manufacturing sites, technical equipment and manufacturing processes (25 points)	
20 - 25 points	Very good	State-of-the-art technology, regularly maintained and innovative systems
12 - 19 points	Satisfactory	Solid equipment, functional and typical industry standard
0 - 11 points	Poor	Outdated or limited equipment, occasional failures

Staff qualification and training (25 points)	
20 - 25 points	Very good	Highly qualified and specialized staff with many years of experience
12 - 19 points	Satisfactory	Expert staff with solid training and relevant experience
0 - 11 points	Poor	Limited specialist knowledge or lack of experience in specific areas

Quality management measures (25 points)	
20 - 25 points	Very good	Convincing, consistent, modern quality management concept
12 - 19 points	Satisfactory	Quality concept available but incomplete
0 - 11 points	Poor	Not available.

Overall rating (100 points)
-	Coherent and comprehensive concept that meets high standards.
-	Solid planning with optimization potential in individual areas.
-	Incomplete or impracticable concept with unfulfilled requirements.

A maximum of 100 points can be achieved for the manufacturing quality concept, representing a maximum of 35% of the quality score.

Formula (quality per concept) = 35 * (bidder´s concept / 100)

***

Overall result
The overall result is calculated from the composition of all points achieved for the individual award criteria.

The contract will be awarded to the highest score bid.


Winner: Ardena Holding N.V.
Award value: 0.01