Supply of consumables, upgrade and maintenance for the NanoAssembler Ignite System

The Unit F.2 is conducting studies into the area of characterization of Lipid Nanoparticles-RNA formulations used in different therapeutic areas, and in particular for some vaccines against COVID-19. Such studies will, in part, contribute to the development of characterization methods for LNP-RNA therapeutics and to their harmonization. For these studies …

CPV: 38437000 Pipetas de laboratorio y sus accesorios, 24000000 Productos químicos, 33696500 Reactivos de laboratorio, 50000000 Servicios de reparación y mantenimiento
Lugar de ejecución:
Supply of consumables, upgrade and maintenance for the NanoAssembler Ignite System
Organismo adjudicador:
European Commission, DG JRC - Joint Research Centre
Número de premio:
EC-JRC/IPR/2024/NP/0967

1. Buyer

1.1 Buyer

Official name : European Commission, DG JRC - Joint Research Centre
Legal type of the buyer : EU institution, body or agency
Activity of the contracting authority : General public services

2. Procedure

2.1 Procedure

Title : Supply of consumables, upgrade and maintenance for the NanoAssembler Ignite System
Description : The Unit F.2 is conducting studies into the area of characterization of Lipid Nanoparticles-RNA formulations used in different therapeutic areas, and in particular for some vaccines against COVID-19. Such studies will, in part, contribute to the development of characterization methods for LNP-RNA therapeutics and to their harmonization. For these studies we have purchased an instrument, the NanoAssembler Ignite System from Precision NanoSystems (JRC/IPR/2021/NP/2748), able to synthesize with high reproducibility Lipid-RNA formulations with composition and characteristics similar to the LNP-mRNA vaccine formulations (size in the 60 to 100 nm size range with low variability and low polydispersivity) with volumes in the 1 to 10 mL range. These characteristics require using single-use microfluidic cartridges, together with provision of appropriate reagents (ionisable lipid in correct mixture with the other needed lipids). Having experienced the great potential of the equipment, we have succesfully won an exploratory reaserch project "PANGOLIN" were the instrument will be used to create Liposomes formulations, furthermore the instrument has been included in the list of acessible istrument for the Outrech Open Lab programme and already requested. In order to fulfill all intended used described above and considering the cost of the consumables (cartriges, off-the shelf LNP reagents like ionisable lipids mixture, with or without dye etc), F.2 Unit wants to launch a negotieted procedure base on the unicity for the supply of reagents to use on the NanoAssembler Ignite System from Precision NanoSystems. Within this procedure we also include maintenance and upgrade kit.
Procedure identifier : eaf0e6d2-0cf4-493e-ad7d-808a327d579c
Internal identifier : EC-JRC/IPR/2024/NP/0967
Type of procedure : Negotiated without prior call for competition
Justification for the accelerated procedure :
Main features of the procedure :

2.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 38437000 Laboratory pipettes and accessories

2.1.4 General information

Legal basis :
Regulation (EU, Euratom) 2018/1046

5. Lot

5.1 Lot technical ID : LOT-0001

Title : Supply of consumables, upgrade and maintenance for the NanoAssembler Ignite System
Description : The Unit F.2 is conducting studies into the area of characterization of Lipid Nanoparticles-RNA formulations used in different therapeutic areas, and in particular for some vaccines against COVID-19. Such studies will, in part, contribute to the development of characterization methods for LNP-RNA therapeutics and to their harmonization. For these studies we have purchased an instrument, the NanoAssembler Ignite System from Precision NanoSystems (JRC/IPR/2021/NP/2748), able to synthesize with high reproducibility Lipid-RNA formulations with composition and characteristics similar to the LNP-mRNA vaccine formulations (size in the 60 to 100 nm size range with low variability and low polydispersivity) with volumes in the 1 to 10 mL range. These characteristics require using single-use microfluidic cartridges, together with provision of appropriate reagents (ionisable lipid in correct mixture with the other needed lipids). Having experienced the great potential of the equipment, we have succesfully won an exploratory reaserch project "PANGOLIN" were the instrument will be used to create Liposomes formulations, furthermore the instrument has been included in the list of acessible istrument for the Outrech Open Lab programme and already requested. In order to fulfill all intended used described above and considering the cost of the consumables (cartriges, off-the shelf LNP reagents like ionisable lipids mixture, with or without dye etc), F.2 Unit wants to launch a negotieted procedure base on the unicity for the supply of reagents to use on the NanoAssembler Ignite System from Precision NanoSystems. Within this procedure we also include maintenance and upgrade kit.
Internal identifier : EC-JRC/IPR/2024/NP/0967

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 38437000 Laboratory pipettes and accessories
Additional classification ( cpv ): 24000000 Chemical products
Additional classification ( cpv ): 33696500 Laboratory reagents
Additional classification ( cpv ): 50000000 Repair and maintenance services

5.1.3 Estimated duration

Duration : 48 Month

5.1.4 Renewal

The buyer reserves the right for additional purchases from the contractor, as described here : The framework contract is concluded for an initial period of 12 (twelve) months, renewable 3 (three) time(s). Please consult the draft framework contract in the procurement documents.

5.1.6 General information

Procurement Project fully or partially financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes
Additional information : Within 2 months of the notification of the award decision, an appeal may be lodged to the review body in Section VI.4.1. You may submit any observations concerning the award procedure to the contracting authority indicated in Section I.1. If you believe that there was maladministration, you may lodge a complaint to the European Ombudsman within two years of the date when you became aware of the facts on which the complaint is based. Such complaint does not have as an effect either to suspend the time-limit to launch an appeal or to open a new period for lodging an appeal.

5.1.10 Award criteria

Criterion :
Type : Price
Name :
Description : Please consult the procurement documents.
Weight (percentage, exact) : 100
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.15 Techniques

Framework agreement :
Framework agreement, without reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : Court of Justice of the European Union
Organisation signing the contract : European Commission, DG JRC - Joint Research Centre
TED eSender : European Commission

6. Results

Maximum value of the framework agreements in this procedure : 413 545,73 Euro
Direct award :
Justification for direct award : The contract can be provided only by a particular economic operator because of an absence of competition for technical reasons
Other justification : in order to fulfill all intended used of the Ignite instrument and considering the cost of the consumables (cartriges, off-the shelf LNP reagents like ionisable lipids mixture, with or without dye etc), F.2 Unit wants to launch a negotiated procedure based on the unicity for the supply of reagents to use on the NanoAssembler Ignite System from Precision NanoSystems. Within this procedure we also include maintenance and upgrade kit which are of exclusivity of Precision Nanosystems

6.1 Result lot ldentifier : LOT-0001

At least one winner was chosen.
Framework agreement :
Maximum value of the framework agreement : 413 545,73 Euro

6.1.2 Information about winners

Winner :
Official name : Cytiva Italy Srl
Tender :
Tender identifier : Cytiva Italy Srl
Identifier of lot or group of lots : LOT-0001
Contract information :
Identifier of the contract : 947312
Date on which the winner was chosen : 22/10/2024
The contract is awarded within a framework agreement : no
Organisation signing the contract : European Commission, DG JRC - Joint Research Centre

6.1.4 Statistical information

Received tenders or requests to participate :
Type of received submissions : Tenders submitted electronically
Number of tenders or requests to participate received : 1

8. Organisations

8.1 ORG-0001

Official name : European Commission, DG JRC - Joint Research Centre
Registration number : COM
Department : JRC.F - Health and Food
Postal address : Via Enrico Fermi 2749
Town : Ispra (VA)
Postcode : I-21027
Country subdivision (NUTS) : Varese ( ITC41 )
Country : Italy
Telephone : +32 2 299 11 11
Internet address : https://ec.europa.eu/jrc/
Roles of this organisation :
Buyer
Organisation signing the contract

8.1 ORG-0002

Official name : Court of Justice of the European Union
Registration number : CURIA
Postal address : Rue du Fort Niedergrünewald
Town : Luxembourg
Postcode : L-2925
Country subdivision (NUTS) : Luxembourg ( LU000 )
Country : Luxembourg
Telephone : +352 4303-1
Internet address : http://curia.europa.eu
Roles of this organisation :
Review organisation

8.1 ORG-0003

Official name : European Commission
Registration number : EUCOM
Postal address : Mondrian (CDMA), Rue du Champ de Mars 21
Town : Brussels
Postcode : B-1050
Country subdivision (NUTS) : Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad ( BE100 )
Country : Belgium
Telephone : +32 2 299 11 11
Roles of this organisation :
TED eSender

8.1 ORG-0004

Official name : Cytiva Italy Srl
Registration number : IT12371320966
Postal address : Via Emilia 26
Town : Buccinasco
Postcode : 20090
Country subdivision (NUTS) : Extra-Regio NUTS 3 ( ITZZZ )
Country : Italy
Telephone : +800529317
Roles of this organisation :
Tenderer
Winner of these lots : LOT-0001

11. Notice information

11.1 Notice information

Notice identifier/version : 8e87f11f-81d1-4f17-8f4a-d94d76f85483 - 01
Form type : Result
Notice type : Contract or concession award notice – standard regime
Notice dispatch date : 23/10/2024 16:46 +02:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00650445-2024
OJ S issue number : 209/2024
Publication date : 25/10/2024