Storage and labelling of GMP Goods | Bicony Therapeutics GmbH | Öffentliches Auftragswesen in Deutschland

Datum	Dokument
2026-03-24	Auftragsbekanntmachung

Kurze Beschreibung

The proper storage of Investigational Medicinal Products (IMPs), GMP-compliant materials, Master Cell Banks (MCBs), and reference standards is a critical requirement to ensure product quality, integrity, and full traceability throughout their lifecycle. All materials must be stored under strictly controlled and continuously monitored conditions in accordance with applicable EU GMP guidelines, ensuring compliance with defined specifications. Therefore, we are looking for a service provider ensuring robust storage systems, including qualified infrastructure, validated monitoring systems, and comprehensive documentation practices fully compliant with regulatory expectations. Please refer to the tender documents for further details.

Beschreibung der Beschaffung

Beschleunigtes 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.

Liste und kurze Beschreibung der Regeln und Kriterien

Please provide the following references. Please use the form provided for this purpose (03_Self-declaration for the eligibility of tenderers) At least three references from reference provider (RP) for the performance of comparable services (The proper storage of Investigational Medicinal Products (IMPs), GMP-compliant materials, Master Cell Banks (MCBs), and reference standards that is robust storage systems, including qualified infrastructure, vali-dated monitoring systems, and comprehensive documentation practices fully compliant with regulatory expectations) since January 1, 2023, (it is sufficient that the comparable services were also 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). Only references to Storage of GMP Goods projects are permitted. Each reference must be either completed or ongo-ing. 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. For verification purposes, the reference details must include the contact details of a responsible person at the respective company, i.e., name, telephone number, and/or email address. Minimum requirements for each reference: 1. Since January 1, 2023 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 include "The proper storage of Investigational Medicinal Products (IMPs), GMP-compliant materials, Master Cell Banks (MCBs), and reference standards that is robust storage systems, including qualified infrastructure, validated monitoring systems, and comprehensive documentation practices fully compliant with regulatory expectations"

Liste und kurze Beschreibung der Regeln und Kriterien

Self-declaration for the following requirements: - QP authorized to approve products for the EU - GMP-compliant labelling Please use the form provided for this purpose (03_Self-declaration for the eligibility of tenderers)

Liste und kurze Beschreibung der Regeln und Kriterien

GMP Certified: issued by EMA (European Medicines Agency) or internationally recognized equivalent. If more than one facility is involved, a separate certificate needs to be available for each. Please submit a copy the relevant certificate with your offer.

Liste und kurze Beschreibung der Regeln und Kriterien

Self-declaration for the following requirement: Handling of antibodies that are not subject to a specific BSL Please use the form provided for this purpose (03_Self-declaration for the eligibility of tenderers)

Genaue Informationen über Fristen für Überprüfungsverfahren

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. 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.