USP & DSP of Corallopyronin A

Universitätsklinikum Bonn AöR

Deadline

Die Frist für den Eingang der Angebote war 2022-09-28. Die Ausschreibung wurde veröffentlicht am 2022-08-29.

Anbieter

Die folgenden Lieferanten werden in Vergabeentscheidungen oder anderen Beschaffungsunterlagen erwähnt:

• Phyton Biotech GmbH

Wer?

• Universitätsklinikum Bonn AöR

Wie?

• Forschungsdienste › Forschungslabordienste

Wo?

• Köln › Bonn, Kreisfreie Stadt

Geschichte der Beschaffung

Datum	Dokument
2022-08-29	Auftragsbekanntmachung
2023-09-20	Bekanntmachung über vergebene Aufträge

Auftragsbekanntmachung (2022-08-29)
Objekt
Umfang der Beschaffung
Titel: Forschungs- und Entwicklungsdienste und zugehörige Beratung
Referenznummer: 2022_11
Kurze Beschreibung: USP & DSP of Corallopyronin A
Metadaten der Bekanntmachung
Originalsprache: Englisch 🗣️
Dokumenttyp: Auftragsbekanntmachung
Art des Auftrags: Dienstleistungen
Verordnung: Europäische Union, mit GPA-Beteiligung
Gemeinsames Vokabular für öffentliche Aufträge (CPV)
Code: Forschungs- und Entwicklungsdienste und zugehörige Beratung 📦
Zusätzlicher CPV-Code: Forschungslabordienste 📦
Ort der Leistung
NUTS-Region: Bonn, Kreisfreie Stadt 🏙️

Verfahren
Verfahrensart: Verhandlungsverfahren
Angebotsart: Angebot für alle Lose
Vergabekriterien
Wirtschaftlichstes Angebot

Öffentlicher Auftraggeber
Identität
Land: Deutschland 🇩🇪
Art des öffentlichen Auftraggebers: Einrichtung des öffentlichen Rechts
Name des öffentlichen Auftraggebers: Universitätsklinikum Bonn AöR
Postanschrift: Venusberg-Campus 1
Postleitzahl: 53127
Postort: Bonn
Kontakt
Internetadresse: http://www.ukbonn.de 🌏
E-Mail: sekretariat.gb4@ukbonn.de 📧
URL der Dokumente: https://www.evergabe.nrw.de/VMPSatellite/notice/CXPNY5YDF6K/documents 🌏
URL der Teilnahme: https://www.evergabe.nrw.de/VMPSatellite/notice/CXPNY5YDF6K 🌏

Referenz
Daten
Absendedatum: 2022-08-29 📅
Einreichungsfrist: 2022-09-28 📅
Veröffentlichungsdatum: 2022-09-02 📅
Kennungen
Bekanntmachungsnummer: 2022/S 169-478179
ABl. S-Ausgabe: 169
Zusätzliche Informationen
Bekanntmachungs-ID: CXPNY5YDF6K

Objekt
Umfang der Beschaffung
Kurze Beschreibung:

The GMP service provider should feature the necessary facility and knowhow to cultivate a S1 bacterial producer strain (bioreactor volume >= 5000 L) and subsequently extract and purify the API (Corallopyronin A) with organic solvents and preparative MPLC to the required purity of >= 90%. Ideally but not required, the service provider is also able to perform the formulation of the API to gain the drug product for use in clinical phase I trials. At the moment the USP and DSP is established up to 15000 L scale. The 15000 L scale will be the maximum size since it is problematic to reach an adequate biomass for production and handle the DSP due to stability issues of the drug substance. Due to these reasons, the CMO service should be charged in regard to bioreactor runs and processed crude material rather than final API quantity. The analytics and stability are established but need to be validated. We would welcome if the technology transfer could be performed in 2022. The required SOPs for USP, DSP, cleaning and formulation are established but adaptations to the SOPs can be suggested according to the available facility equipment or local conditions.

The consortium of the Corallopyronin (CorA) project, led by University Hospital Bonn with involvement of the Helmholtz Centre of lnfection Research (HZl), has developed a fermentation procedure with the heterologous producer strain Myxococcus xanthus DKL622::pDPOmxn116-Pvan-Tpase (S1 GMO), the corresponding downstream processing protocol for the extraction and purification of CorA (API) and established the formulation to perform toxicology studies. The small molecule CorA (natural product) is a bacterial RNA polymerase inhibitor and a promising candidate as antiparasitic and antibacterial drug currently in preclinical development with planned phase I clinical trials in Q3/2024. The primary indication is onchocerciasis intended for human and animal use. Secondary indications are MRSA bloodstream infections and sexually transmitted infections caused by Neisseria and Chlamydia. The non-GLP in vitro toxicity studies (micronucleus, AMES, hERG, phototoxicity, off-target profiling) are finalized with no results that are of relevant concern at this stage. A safety data sheet for CorA is in preparation. The maximal tolerated dose (MTD) in dog was very high (1000 mg/kg), with mild symptoms at 500 mg/kg, which were reversible after 150 minutes. The 7-day repeated dose toxicity in rat will be conducted in July 2022, the 7-day repeated dose toxicity study in dog will start in autumn 2022. The MTD for rat was very high (1000 mg/kg) and the animals tolerated this dose for four consecutive days. The project was able to attract public funding from the German Ministry of Education and Research to prove safety and efficacy in humans and to de-risk the technology for potential investors and out-licensing activities to pharma industry.

Dauer: 27 Monate
Beschreibung der Optionen:

Formulation of the API/Drug Product Manufacturing:

- Formulation of the API with polymer solution to gain clinical test material (drug product).

- Formulation includes spray drying, dry granulation, milling, sieving and filling into gastro resistant capsules.

- Manufacturing Authorization according to § 13 (1) AMG and respective GMP certificate for the manufacture of Investigational Medicinal Products (IMP) for use in clinical trials.

Ort der Leistung
Hauptstandort oder Erfüllungsort: Facility of the provider.

Rechtliche, wirtschaftliche, finanzielle und technische Informationen
Bedingungen für die Teilnahme
Wirtschaftliche und finanzielle Leistungsfähigkeit:

- By written statement: provider should have sustainable/ profitable track record in the contract development and manufacturing space, e.g. reference to public domain.

Technische und berufliche Fähigkeiten:

- By certificate: local legal requirements for manufacture of an API via GMO fermentation (microbial) for an Investigational Medicinal Product to be used in clinical trials phase I-III according to current EU legislation (Regulation (EU) No 536/2014), e.g. Manufacturing Authorization according to § 13 (1) AMG. Candidates are also accepted that comply with cGMP standards and commit to obtain the required manufacturing authorization on a timeline acceptable for the clinical trial material production.

- By certificate: permission to handle and cultivate a biosafety level 1 bacterial producer strain (GMO).

- By certificate: permission to handle and dispose larger volumes of acids and organic solvents.

- By written statement: availability of the main bioreactor (>= 5000 L) and corresponding bioreactors for the seed cultures as well as adequate DSP equipment.

- By written statement: personnel are trained and qualified for the required process.

Informationen über einen bestimmten Beruf: Services
Verweis auf einschlägige Rechts- oder Verwaltungsvorschriften:

Local legal requirements for manufacture of an API via GMO fermentation (microbial) for an Investigational Medicinal Product to be used in clinical trials phase I-III according to current EU legislation (Regulation (EU) No 536/2014), e.g. Manufacturing Authorization according to § 13 (1) AMG. Candidates are also accepted that comply with cGMP standards and commit to obtain the required manufacturing authorization on a timeline acceptable for the clinical trial material production.

Auftragsausführung
Bedingungen für die Vertragserfüllung:

The entire process will be awarded to the CMO as a phased contract and should run sequential after successful completion of each work package. A Master Service Agreement (MSA) or framework agreement is preferred to facilitate the commission of the required work packages. There will be a commercial agreement and an additional quality assurance agreement.

It is expected to have acceptable waiting times for room and equipment bookings to avoid delays in the timelines. The main delivery is the API Corallopyronin A (purity >= 90%) for the use as clinical trial material in Q3/2024.

Work packages include the USP and DSP of, e.g.:

1. Feasibility study (>= 100 L) to prove capability to handle the bacterial strain, the fermentation and the DSP. Larger volumes are welcome whereas smaller volumes are not accepted since <100 L doesn't reflect the behavior in larger scale bioreactors.

2. Technical run(s) (bioreactor volume >= 5000 L) to produce material for remaining preclinical studies and to establish the validation methods for the production under GMP, e.g. analytics, stability, cleaning, ethics.

3. Engineering run/test run for GMP production (bioreactor volume >= 5000 L).

4. GMP run(s) (bioreactor volume >= 5000 L) to produce clinical trial material.

Verfahren
Rechtsgrundlage: 32014L0024
Mindestzahl der Bewerber: 3
Zeitpunkt des Eingangs der Angebote: 23:59
Datum der Absendung der Aufforderungen: 2022-08-28 📅
Sprachen, in denen Angebote oder Teilnahmeanträge eingereicht werden können: Deutsch 🗣️
Englisch 🗣️
Gültigkeitsdauer des Angebots: 2 Monate

Öffentlicher Auftraggeber
Kontakt
Internetadresse: www.ukbonn.de 🌏
Dokumente URL: https://www.evergabe.nrw.de/VMPSatellite/notice/CXPNY5YDF6K/documents 🌏

Ergänzende Informationen
Körper überprüfen
Name: Vergabekammer Rheinland c/o Bezirksregierung Köln
Postanschrift: Zeughausstraße 2-10
Postort: Köln
Postleitzahl: 50667
Land: Deutschland 🇩🇪
Informationen zu Fristen für Nachprüfungsverfahren:

The award procedure is subject to review in a review procedure pursuant to section 155 et seq. of the "act against restraints of competition" (GWB). The competent procurement chamber shall initiate review proceedings only upon application (section 160 (1) GWB). An application for review is inadmissible pursuant to section 160 (3) sentence 1 GWB insofar as:

1. the applicant has recognized the asserted infringement of procurement regulations prior to submitting the application for review and has not objected to it towards the contracting entity within a period of ten calendar days; the expiry of the period pursuant to section 134 (2) shall remain unaffected,

2. violations of procurement regulations which are apparent from the notice are not notified to the contracting entity until the expiry of the period for application or submission of bids specified in the notice,

3. violations of procurement regulations which are only recognizable in the award documents are not notified to the contracting entity at the latest by the expiry of the period for application or submission of bids,

4. more than 15 calendar days have elapsed since receipt of the contracting entity's notification that it does not intend to remedy a complaint.

Quelle: OJS 2022/S 169-478179 (2022-08-29)

Bekanntmachung über vergebene Aufträge (2023-09-20)
Objekt
Umfang der Beschaffung
Gesamtwert des Auftrags: 8 758 000 EUR 💰
Metadaten der Bekanntmachung
Dokumenttyp: Bekanntmachung über vergebene Aufträge

Verfahren
Angebotsart: Entfällt

Referenz
Daten
Absendedatum: 2023-09-20 📅
Veröffentlichungsdatum: 2023-09-25 📅
Kennungen
Bekanntmachungsnummer: 2023/S 184-576058
Verweist auf Bekanntmachung: 2022/S 169-478179
ABl. S-Ausgabe: 184
Zusätzliche Informationen
Bekanntmachungs-ID: CXPNY5YDJED

Verfahren
Vergabekriterien
Qualitätskriterium (Bezeichnung): Technische Eignung
Qualitätskriterium (Gewichtung): 60
Preis (Gewichtung): 40

Auftragsvergabe
Datum des Vertragsabschlusses: 2023-09-20 📅
Name: Phyton Biotech GmbH
Postanschrift: Alter Postweg 1
Postort: Ahrensburg
Postleitzahl: 22926
Land: Deutschland 🇩🇪
Telefon: +49 4102490664 📞
E-Mail: kai.schuette@phytonbiotech.com 📧
Land: Bonn, Kreisfreie Stadt 🏙️
Internetadresse: http://phytonbiotech.com 🌏
Gesamtwert des Auftrags: 8 758 000 EUR 💰
Informationen über Ausschreibungen
Anzahl der eingegangenen Angebote: 1
Quelle: OJS 2023/S 184-576058 (2023-09-20)

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