Verfahrensangaben

Central Laboratory Services for Clinical Trial

VO: VgV Vergabeart: Offenes Verfahren Status: Veröffentlicht

Fristen

Fristen
26.10.2026
04.11.2026 11:00 Uhr
04.11.2026 11:01 Uhr

Adressen/Auftraggeber

Auftraggeber

Auftraggeber

BiconY Therapeutics GmbH
HRB 41594
Lagerhofstraße 4
04103
Leipzig
Deutschland
DED51
bicony.tenderprocedure@fgvw.de
+49 69 7191890-12

Angaben zum Auftraggeber

Von einer Bundesbehörde kontrolliertes oder finanziertes öffentliches Unternehmen
Wirtschaftliche Angelegenheiten

Gemeinsame Beschaffung

Beschaffungsdienstleister
Weitere Auskünfte
Rechtsbehelfsverfahren / Nachprüfungsverfahren

Stelle, die Auskünfte über die Einlegung von Rechtsbehelfen erteilt

Zuständige Stelle für Rechtsbehelfs-/Nachprüfungsverfahren

Vergabekammer des Budnes
022894990
Kaiser-Friedrich-Straße 16
53113
Bonn
Deutschland
DEA22
Vergabekammer des Bundes beim Bundeskartellamt
vk@bundeskartellamt.bund.de
+492289499163

Zuständige Stelle für Schlichtungsverfahren

Auftragsgegenstand

Klassifikation des Auftrags
Dienstleistungen

CPV-Codes

85100000-0
Umfang der Beschaffung

Kurze Beschreibung

The Federal Agency for Disruptive Innovation - SPRIND GmbH ("SPRIND") - aims to create new disruptive innovations from Germany. That means products, services and systems that make all our lives noticeably and sustainably better. To achieve this, SPRIND brings together new thinkers from science and business, people with outstanding ideas, special expertise, and passion. Hence, SPRIND provides an entrepreneurial environment that turns ideas into reality.

The objective of BiconY Therapeutics GmbH, a SPRIND subsidiary, is the development of a bispecific antibody combination for the treatment of solid tumours. The combination consists of proprietary, bispecific CD3 anti-bodies (bsAbCD3) and bispecific CD28 co-stimulators (BiCos), which, when used together, significantly improve the specificity, sustainability, and efficiency of a T cell recruitment and thus the immune response against tumour cells. The aim of the research and development activities is to provide proof of concept for the effect of bispecific antibody therapy in the form of two phase I/IIa clinical trials.

For the conduct of the planned phase I/IIa clinical trials, comprehensive central laboratory services are required for the collection logistics, processing, analysis, management, distribution and long-term storage of the biological specimens obtained from the trial participants. This includes in particular the analysis of cytokines in serum and the isolation of peripheral blood mononuclear cells (PBMC). Therefore, BiconY is looking for a service provider to act as central laboratory for these clinical trials.

Please refer to the tender documents for further details.

Beschreibung der Beschaffung (Art und Umfang der Dienstleistung bzw. Angabe der Bedürfnisse und Anforderungen)

The Federal Agency for Disruptive Innovation - SPRIND GmbH ("SPRIND") - aims to create new disruptive innovations from Germany. That means products, services and systems that make all our lives noticeably and sustainably better. To achieve this, SPRIND brings together new thinkers from science and business, people with outstanding ideas, special expertise, and passion. Hence, SPRIND provides an entrepreneurial environment that turns ideas into reality.

The objective of BiconY Therapeutics GmbH, a SPRIND subsidiary, is the development of a bispecific antibody combination for the treatment of solid tumours. The combination con-sists of proprietary, bispecific CD3 anti-bodies (bsAbCD3) and bispecific CD28 co-stimulators (BiCos), which, when used together, significantly im-prove the specificity, sus-tainability, and efficiency of a T cell recruitment and thus the immune response against tumour cells. The aim of the research and development activities is to provide proof of con-cept for the effect of bispecific antibody therapy in the form of two phase I/IIa clinical trials.

For the conduct of the planned phase I/IIa clinical trials, comprehensive central laboratory services are required for the collection logistics, processing, analysis, management, distri-bution and long-term storage of the biological specimens obtained from the trial participants. This includes in particular the analysis of cytokines in serum and the isolation of peripheral blood mononuclear cells (PBMC). Therefore, BiconY is looking for a service provider to act as central laboratory for these clinical trials.

Please refer to the tender documents for further details.

Umfang der Auftragsvergabe

EUR

Laufzeit des Vertrags, der Rahmenvereinbarung oder des dynamischen Beschaffungssystems

Laufzeit in Monaten
18

There is the option to extend the contract.

2
Erfüllungsort(e)

Erfüllungsort(e)

Ort im Europäischen Wirtschaftsraum
---

Weitere Erfüllungsorte

Zuschlagskriterien

Zuschlagskriterien

---
Weitere Informationen

Angaben zu Mitteln der europäischen Union

Angaben zu KMU

Angaben zu Optionen

Zusätzliche Angaben

Verfahren

Verfahrensart

Verfahrensart

Offenes Verfahren

The current service provider has informed the Client (contracting entity, BiconY Therapeu-tics GmbH, hereinafter also called "BiconY") recently in March 2026 that he will be discontinuing his business operations, with operational activities expected to wind down by end of June. The Client will receive batch releases by end of April from their Contract Manufac-turing Organization (CMO) and must ship it to the new, long term service provider. For this reason, there is a case of urgency that could not have been foreseen by the Client.

Angaben zum Verfahren

This is an e open procedure. No negoatiations will take place.

Angaben zum Beschaffungsübereinkommen (GPA)

Besondere Methoden und Instrumente im Vergabeverfahren

Angaben zur Rahmenvereinbarung

Entfällt

Angaben zum dynamischen Beschaffungssystem

Entfällt

Angaben zur elektronischen Auktion

Angaben zur Wiederkehr von Aufträgen

Angaben zur Wiederkehr von Aufträgen

Strategische Auftragsvergabe

Strategische Auftragsvergabe

Gesetz über die Beschaffung sauberer Straßenfahrzeuge

Energieeffizienz-Richtlinie

Angaben zu elektronischen Arbeitsabläufen

Angaben zu elektronischen Arbeitsabläufen

Erforderlich
Auftragsunterlagen

Sprache der Auftragsunterlagen

Englisch
Sonstiges / Weitere Angaben

Kommunikationskanal


All communication takes place in English via communication tool in the project area of the procurement portal DTVP.

https://www.dtvp.de/Satellite/notice/CXP4D9LM2JY

Einlegung von Rechtsbehelfen

According to Article 160, Section 3 of the German Act Against Restraint of Competition (GWB), application for review is not permissible insofar as
1. the applicant has identified the claimed infringement of the procurement rules before submitting the application for review and has not submitted a complaint to the contracting authority within a period of 10 calendar days; the expiry of the period pursuant to Article 134, Section 2 remains unaffected,
2. complaints of infringements of procurement rules that are evident in the tender notice are not submitted to the contracting authority at the latest by the expiry of the deadline for the application or by the deadline for the submission of bids, specified in the tender notice.
3. complaints of infringements of procurement rules that first become evident in the tender documents are not submitted to the contracting authority at the latest by the expiry of the deadline for application or by the deadline for the submission of bids,
4. more than 15 calendar days have expired since receipt of notification from the contracting authority that it is unwilling to redress the complaint,
5. there is a manifest abuse of the right to make an application or lodge a complaint in accordance with section 180(2).
Sentence 1 does not apply in the case of an application to determine the invalidity of the contract in accordance with Article 135, Section 1 (2). Article 134, Section 1, Sentence 2 remains unaffected.

Frühere Bekanntmachung zu diesem Verfahren

Anwendbarkeit der Verordnung zu drittstaatlichen Subventionen

Zusätzliche Informationen

Angebote

Anforderungen an Angebote / Teilnahmeanträge

Übermittlung der Angebote / Teilnahmeanträge

Anforderungen an die Form bei elektronischer Übermittlung

Sprache(n), in der (denen) Angebote / Teilnahmeanträge eingereicht werden können

Englisch

Nebenangebote

Nicht zulässig

Elektronische Kataloge

Nicht zulässig

Mehrere Angebote pro Bieter

Nicht zulässig
Verwaltungsangaben

Bindefrist

8
Wochen

Bedingungen für die Öffnung der Angebote

Nachforderung

Eine Nachforderung von Erklärungen, Unterlagen und Nachweisen ist nicht ausgeschlossen.

Bicony asks - within its discretion - the bidder to submit, complete or correct documents, within the framework laid down by law.

Bedingungen

Ausschlussgründe

Ort der Angabe der Ausschlussgründe

Auswahl der Ausschlussgründe

In accordance with §§ 123,124 GWB, § 22 LkSG

Teilnahmebedingungen

Eignungskriterien / Ausschreibungsbedingungen

Ort der Angabe der Eignungskriterien

Eignungskriterium

Referenzen zu bestimmten Dienstleistungen

Please provide the following references. Please use the form provided for this purpose (03_Self-declaration for the eligibility of tenderers)

At least five references as central laboratory in clinical studies with cytokine multiplex analysis and/or specimen management since October 1, 2022, (it is sufficient that the studies were provided in the reference period in the specified reference project, e.g., a reference that began on January 1, 2022, and ended on February 1, 2023, would be sufficient). Each reference must be either completed or ongoing. In the case of an ongoing reference, specifications of the planned/contractual project duration and information on the current status must be included.

It is irrelevant whether the reference provider is a public or private company.
BiconY reserves the right to verify the listed studies with the sponsors.

Minimum requirements for each of the five references:

1. Since October 1, 2022
2. Completed and ongoing reference; if ongoing, specifications of the planned/contractual project duration and information on the current status of the reference project must be included
3. The respective reference must be as central laboratory in clinical studies with cytokine multiplex analysis and/or specimen management.

Eignungskriterium

Zertifikate von unabhängigen Stellen über Qualitätssicherungsstandards

Accreditation / GCLP: The central laboratory is accredited according to ISO 15189 (or equivalent, e.g. CAP/CLIA) and operates in compliance with GCP/GCLP (Good Clinical Laboratory Practice). If more than one facility is involved, a separate accreditation / certificate needs to be available for each. A copy of the relevant certificate must be attached to the tender.

Eignungskriterium

Maßnahmen zur Sicherstellung der Qualität

Self-Declaration on
compliance with Good Clinical Practice (ICH E6) and with applicable data-protection requirements (GDPR / Regulation (EU) 2016/679) for the handling of human biological specimens and associated data, together with the relevant imple-mented national law (or comparable rules where a provision is not applicable to the bidder/bidding consortium).

Finanzierung

Rechtsform des Bieters

Bedingungen für den Auftrag

Bedingungen für den Auftrag

Place of performance:
Company and central labor is based in the EU.

Angaben zu geschützten Beschäftigungsverhältnissen

Nein

Angaben zur reservierten Teilnahme

Angaben zur beruflichen Qualifikation

Erforderlich für das Angebot

Angaben zur Sicherheitsüberprüfung