Expansion of G3Lab Bioprocess Controllers, Delta-V and Bioreactor Capability

NIBRT currently has as part of its Analytics & Characterisation laboratory, 2 G3Lab controllers, one with a 7-litre glass bioreactor and one with a 3-litre glass bioreactor, acquired from Finesse in 2017, which is now part of ThermoFisher Scientific.

The company now wishes to award a contract to expand the platform into an operational 7-litre four pack and to acquire an additional 7-litre vessel, and controller together with an upgrade to the TruBio Delta-V platform to allow for additional hardware capacity. The purpose of this expansion is to support a growing volume of work in advanced process related research.

National Institute For Bioprocessing Research and Training (NIBRT), Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin

• Finesse bioreactors produce biotherapeutics in a controlled and sterile environment.

• The mass flow controllers (MFCs) built into the G3Lab controllers allow for accurate control over the flow rate of gases entering the vessels which can have an impact on the characteristics of the product being formed.

• This control is managed through the Delta-V software.

• Aside from controlling the flow rate of gases the Delta-V software is capable of monitoring important variables within the vessel such as temperature, pH and gas concentration over time. It is important that these parameters are controlled and monitored carefully as they can have an impact on product characteristics. The signals for these parameters are sent from probes inserted into the bioreactor, attached to the G3Lab controllers and represented within Delta-V.

As per Article 32 of EU Directive 2014/24, NIBRT wishes to avail of the negotiated procedure without prior publication.

Explanation:

The contract can only be performed by Thermo Fisher for the following reasons, which fall under paragraph 3(b) of Article 32 of EU Directive 2014/24:

• Interoperability of the new equipment with the existing controllers and bioreactors acquired in 2017. The additional equipment is intended to be an extension of the original acquisitions. Were a different contractor and brand to be used, the equipment would have different technical characteristics which would result in incompatibility or disproportionate technical difficulties in operations and maintenance. The original equipment would in effect require repurchase under the new brand at a significant cost to complete the proposed platform.

• Interoperability with other equipment in the Analytics & Characterisation laboratory, including the LC-MS systems.