vergebenEU-weitDienstleistungen 1 Berichtigung

SMALL MOLECULE CONTRACT MANUFACTURING SERVICES

Helmholtz-Zentrum für Infektionsforschung GmbH · Braunschweig, Niedersachsen

Aktenzeichen 028/006/2025veröffentlicht 16.02.2025erstmals 16.02.2025DienstleistungenOffenes Verfahren

Laufzeit: 4 Jahre; bis zu 2 Verlängerungen
Hauptleistung: Dienstleistungen im Bereich Forschung und experimentelle Entwicklung; CPV 73100000
Verfahren: Offenes Verfahren

Angebotsfrist18.03.2025, 23:59 Uhrseit 599 Tagen abgelaufen

Zur Bekanntmachungsubreport.de

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Alle Ausschreibungen: Dienstleistungen in Niedersachsen (137 offen)

Auf einen Blick

Art des Auftrags: Dienstleistungen
Geschätzter Wert: keine Angabe
Laufzeit: 4 Jahrebis zu 2 Verlängerungen
Lose: 1
Verfahren: Offenes VerfahrenVgV, EU-weit
Rahmenvereinbarung: nein
Ort der Leistung: Braunschweig38124, Niedersachsen
Einreichung: elektronisch: Erforderlichsubreport.de

Schnellprüfung für Bieter

Unterlagen frei zugänglichnein
Elektronische Einreichung verpflichtendja
Nebenangebote zugelassennein
Mehrere Hauptangebote zugelassennein
Laut Auftraggeber für KMU geeignetnein
Sicherheiten verlangtkeine Angabe
Teilnahme vorbehalten (z. B. Werkstätten)nein
E-Rechnung verpflichtendja
Vertraulichkeitserklärung verlangtja
Elektronische Auktionnein
Aus EU-Mitteln finanziertnein
Wiederkehrender Auftragkeine Angabe

Einordnungvon uns ausgewertet

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Was jetzt zu tun ist

Unterlagen auf der Vergabeplattform abrufen und das Angebot vollständig bis zur Angebotsfrist abgeben.

Bei dieser Vergabestelle vergehen von der ersten Meldung bis zum Ergebnis im Mittel 82 Tage (13 Verfahren, 24 Monate).

Sie erhält im Median 4 Angebote je Los (9 Lose mit Angabe).

Wertung laut Bekanntmachung: Preis 30 %, Leistung und Qualität 70 %.

Weighting (exact percentage): 3030 %
Weighting (exact percentage): 3535 %
Weighting (exact percentage): 3535 %

Unterlagen schon heruntergeladen? Vergabeunterlagen prüfen (Team): Fristen, Gewichtung, Mengen, Zertifikate und Fehler im Preisblatt.

Was kostet ein höherer Preis an Punkten?

Mein Angebot ist% teurer als das günstigste.

Das kostet etwa 5 von 100 Punkten der Gesamtwertung.

Punktverlust je Mehrpreis
10 % teurer	−2,7 Punkte
25 % teurer	−6 Punkte
50 % teurer	−10 Punkte
100 % teurer	−15 Punkte

Annahme: Preispunkte = günstigstes Angebot geteilt durch das eigene. Die verbindliche Formel steht in den Vergabeunterlagen.

Fristen und TermineStand 08.11.2026

16.02.2025
Erstveröffentlichung
vor 21 Monaten
16.02.2025
1. Berichtigung (diese Fassung)
vor 21 Monaten
05.03.2025
Fragen bis 23:59 Uhr
an Helmholtz-Zentrum für Infektionsforschung GmbH
vor 20 Monaten
18.03.2025
Angebotsfrist 23:59 Uhr
nur elektronisch über subreport.de
vor 20 Monaten
18.03.2025
Öffnung der Angebote 23:59 Uhr
vor 20 Monaten
19.06.2025
Bindefrist endet
3 Monate ab Angebotsfrist, von uns berechnet
vor 17 Monaten
08.11.2026
Heute

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

Gegenstand nach CPV

73100000 Dienstleistungen im Bereich Forschung und experimentelle EntwicklungHauptgegenstand
33600000 Arzneimittel

Bedingungen

Zuschlag3 von 3 angegeben

Weighting (exact percentage): 3030 %

Weighting (exact percentage): 3535 %

Preis: Weighting (exact percentage): 30Evaluation 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)
Qualität: Weighting (exact percentage): 35Submission 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)
Qualität: Weighting (exact percentage): 35Submission 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.

Eignung6 von 6 angegeben

Kriterium: Applicants should submit the following documents with the offer if possible (from each member in the case of consortia): #a) Informal company presentation stating the name, registered office, contact details, VAT identification number and entry in the commercial register/professional register. #b) … ganz lesenkürzer
Applicants should submit the following documents with the offer if possible (from each member in the case of consortia): #a) Informal company presentation stating the name, registered office, contact details, VAT identification number and entry in the commercial register/professional register. #b) Informal self-declaration sating that - there are no grounds for exclusion within the meaning of §§ 123, 124 GWB respectively that successful self-remediation measures within the meaning of § 125 GWB have been carried out; - that they comply with the provisions of Art. 5k of the Regulation (EU) 833/2014 in the version of Art. 1 point 22 of Council Regulation (EU) 2023/1214 of June 23, 2023 as part of the EU sanctions package related to Russia's war of aggression on Ukraine. #c) Applicant consortia should also submit a declaration stating that there has been no breach of antitrust law and that no unlawful agreements restricting competition have been made. Applicants should use the forms provided by the Contracting Authority. The Contracting Authority reserves the right to request additional documents in accordance with § 56 (2) VgV. There is no legal entitlement to this.
Kriterium: If possible, applicants should submit the following documents with their tender (in the case of applicant consortia with at least one member): #a) Confirmation that the applicant maintains professional indemnity/company liability insurance with cover of at least EUR 5 million per claim, 2 times maxi … ganz lesenkürzer
If possible, applicants should submit the following documents with their tender (in the case of applicant consortia with at least one member): #a) Confirmation that the applicant maintains professional indemnity/company liability insurance with cover of at least EUR 5 million per claim, 2 times maximum, or will take out such insurance if the contract is awarded. In the event that a candidate wishes to use individual companies as subcontractors, reference is made to the possibility of suitability lending and the requirements specified in Section 47 VgV. If and insofar as the applicant relies on the suitability of the subcontractor, a declaration of commitment from the subcontractor that it will make its resources and capacities available to the applicant in the event of a contract being awarded must be submitted with the tender. Applicants should use the forms provided by the contracting authority. The contracting authority reserves the right to request additional documents in accordance with Section 56 (2) VgV; there is no legal entitlement to this.
Kriterium: Applicants should submit the following documents with the offer if possible (in the case of applicant consortia of at least one member): Informal self-declaration in which the applicant states whether and how it intends to cooperate with other companies in the event of a contract. Applicant consort … ganz lesenkürzer
Applicants should submit the following documents with the offer if possible (in the case of applicant consortia of at least one member): Informal self-declaration in which the applicant states whether and how it intends to cooperate with other companies in the event of a contract. Applicant consortia are considered as a whole when assessing the suitability. In the event that an applicant / a consortium of applicants wishes to use individual companies as subcontractors, reference is made to the possibility of suitability lending and the requirements specified in § 47 VgV. If and insofar as the applicant / consortium of applicants relies on the suitability of the subcontractor, a declaration of commitment by the subcontractor that it will make its resources and capacities available to the applicant / consortium of applicants in the event of a contract must be submitted with the application. Applicants should use the forms provided by the Contracting Authority. The Contracting Authority reserves the right to request additional documents in accordance with § 56 (2) VgV. There is no legal entitlement to this.
Kriterium: In addition, proof of suitability is required by written statement for the following project specific matters: referece for proving his competence and experience with formulation development in the research phase.
Nachreichen von Unterlagen: Die Nachforderung von Erklärungen, Unterlagen und Nachweisen ist nicht ausgeschlossen.
Ausschlussgründe: Rein nationale Ausschlussgründe, Schwere Verfehlung

Laufzeit und Umfang4 von 6 angegeben

Vertragsbeginn: keine Angabe
Vertragsende: keine Angabe
Dauer: 4 Jahre
Verlängerung: bis zu 2-mal
Optionen: Minimum contract term: 1 year (with the completion of SCOPE 1)***Optional contract terms: 2 extensions (1,5 years/1,5 years; max. 4 years in total)***End: With the completion of SCOPE 2 and 3 (expected end: 12/2028) If the contract is not cancelled at least three months before its expiry date, it wi … ganz lesenkürzer
Minimum contract term: 1 year (with the completion of SCOPE 1)***Optional contract terms: 2 extensions (1,5 years/1,5 years; max. 4 years in total)***End: With the completion of SCOPE 2 and 3 (expected end: 12/2028) If the contract is not cancelled at least three months before its expiry date, it will be automatically renewed for a further year. The contract ends automatically when the maximum term of 4 years is reached without prior cancellation.
Rahmenvereinbarung: nein

Angebot und Einreichung9 von 10 angegeben

Elektronische Einreichung: Erforderlich
Einreichung über: subreport.de
Sprache: Englisch, Deutsch
Nebenangebote: Nicht zulässig
Mehrere Hauptangebote: Nicht zulässig
Elektronische Signatur: nicht verlangt
Elektronischer Katalog: Nicht zulässig
Bindefrist: 3 Monate
Angebotsöffnung: 18.03.2025, 23:59 Uhr
Sicherheiten: keine Angabe

Ausführung6 von 6 angegeben

Vertraulichkeit: Erklärung verlangt
E-Rechnung: Erforderlich
Elektronische Bestellung: wird genutzt
Elektronische Zahlung: wird genutzt
Vorbehaltene Ausführung: Nein
EU-Mittel: Auftragsvergabeprojekt nicht aus EU-Mitteln finanziert

Rechtsschutz3 von 3 angegeben

Nachprüfungsstelle: Vergabekammer des Bundes, Villemombler Straße 76, 53123 Bonn
Fristen für Nachprüfungsanträge: 1) A review procedure before the Public Procurement Tribunal is inadmissible pursuant to Section 160 (3) Sentence 1 No. 4 ARC if more than 15 calendar days have elapsed since receipt of the contracting authority's notification that it does not intend to remedy a complaint. 2) In particular, Sectio … ganz lesenkürzer
1) A review procedure before the Public Procurement Tribunal is inadmissible pursuant to Section 160 (3) Sentence 1 No. 4 ARC if more than 15 calendar days have elapsed since receipt of the contracting authority's notification that it does not intend to remedy a complaint. 2) In particular, Section 160 (3) Sentence 1 Nos. 1, 2 and 3 of the ARC and Section 134 (2) of the ARC shall be observed. 3) The period for asserting the invalidity of the contract pursuant to Section 135 of the ARC ends no later than 30 calendar days after publication of the notice of award procedures in the Official Journal of the European Union; see Section 135(2), second sentence, of the ARC.
Beschaffungsübereinkommen (GPA): fällt darunter

Zusätzliche Informationen2 von 2 angegeben

Hinweis: The following A-criteria (minimum requirements) must be met and explicitly confirmed by the bidder with a 'Yes'. Failure to meet at least one of these A Criteria will result in the exclusion of the tender from further consideration: > Compliant with the principles of Good Manufacturing Practices? ( … ganz lesenkürzer
The following A-criteria (minimum requirements) must be met and explicitly confirmed by the bidder with a 'Yes'. Failure to meet at least one of these A Criteria will result in the exclusion of the tender from further consideration: > Compliant with the principles of Good Manufacturing Practices? (certificate(s) of GMP compliance for drug substance, injectable products and semi-solids have to be handed in) > Regulatory Release of IMPs in the European Union? (By certificate) > Qualified to manufacture the following IMPs: sterile liquids (injectable dosage form) and semi-solids (topical dosage form)? (please provide authorizations as applicable) > Existing business liability insurance policy with minimum coverage of EUR 5m per occurence and policy year? (please answer yes or no) > Competence and Experience with formulation development in the research phase available (one references has to be handed in) *** A valid tender cannot be submitted without a CDA. To obtain the confidential document ' A_05_(AFTER CDA)_AdditionalConfidentialInformation', the signed CDA must be submitted by 28 February at the latest. It is possible to submit the CDA later, but this is the bidder's responsibility. If a bidder submits the CDA after 28 February, the bidder runs the risk that the remaining time may not be sufficient to prepare a complete and timely bid. The contracting authority is under no obligation to extend the tender deadline as a result of a late submission. The CDA can be requested up to five days before the tender deadline. Subcontractors must also sign and submit the CDA. Disclosure of confidential information by the main contractor is not permitted. *** In order to verify the information provided in the tender (in particular the concepts), the contracting authority reserves the right to invite the two best bidders to a verification tender presentation. The purpose of the tender submission is the verification of the information provided by the tenderer. No negotiations will take place and no changes can be made to the offer. The offer presentation is expected to take place on 3 April 2025. The exact time and any change of the date will be communicated via the Tender Platform by 1 April 2025. The contracting authority reserves the right to correct the evaluation of the concept in case of non-performance or insufficient performance.
Hinweis: In order to obtain the confidential document “A_05_AdditionalConfidentialInformation”, the signed CDA “A_01_CDA_small molecule manufacturing .doc” must be submitted. This is a prerequisite for submitting a valid offer. Subcontractors must also sign and submit the CDA. The main contractor is not allo … ganz lesenkürzer
In order to obtain the confidential document “A_05_AdditionalConfidentialInformation”, the signed CDA “A_01_CDA_small molecule manufacturing .doc” must be submitted. This is a prerequisite for submitting a valid offer. Subcontractors must also sign and submit the CDA. The main contractor is not allowed to pass on the confidential information. Documents that become part oft he contract and must be completed, signed and enclosed with the offer: 1. A_01_CDA_small molecule manufacturing 2. A_03_Price Schedule 3. A_04_Catalogue A_cirtiera 4. A_05_(AFTER CDA)_AdditionalConfidentialInformation 5. B_01_Data protection 6. C_00_Declaration on Exclusion Grounds 7. C_01_Self-declaration 8. C_02_Declaration_EU sanctions 9. C_03_Questions by applicants 10. D_01_Submission of Tender 11. D_02_Terms and Conditions 12. Project Schedule (according to B_02_Submission of a Project Schedule) 13. manufacturing quality concept (according to B_03_Submission of a manufacturing quality concept) Documents that become part oft he contract and remain with the bidder: 14. B_00_Cover Letter 15. A_02_Performance description 16. Additional Contractual Conditions Further documents that must be enclosed with the offer: 17. D_00_Master Service Agreement-Template_20231127 (for information only)

Bezeichnungen aus den amtlichen eForms-Codelisten (EU und eForms-DE). Maßgeblich sind die Vergabeunterlagen.

AuftraggeberZur Seite der Vergabestelle

Name: Helmholtz-Zentrum für Infektionsforschung GmbH
Art: Körperschaften des öffentlichen Rechts auf Bundesebene, Gesundheit
Anschrift: Inhoffenstr. 7, 38124 Braunschweig
Website: helmholtz-hzi.de
Kontakt: einkauf@helmholtz-hzi.de

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Vergabemeldungen der letzten 24 Monate mit Hauptgegenstand CPV 731 (Dienstleistungen im Bereich Forschung und experimentelle Entwicklung) in Niedersachsen. Abgeleitet aus veröffentlichten Bekanntmachungen, keine amtliche Statistik. Zuschlagswerte unter 1.000 € zählen wir als Platzhalter nicht mit.

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