Purchase of Alternating Tangential Flow (ATF) Non-GMP Equipment

Schedule 5, paragraph 6 of the Procurement Act 2023 provides for the following justification for directly awarding contracts where there is only a single supplier who can meet the requirement:

"The following conditions are met in relation to the public contract-

(a)due to an absence of competition for technical reasons, only a particular supplier can supply the goods, services or works required, and

(b)there are no reasonable alternatives to those goods, services or works."

This purchase is for a lab base non-GMP system, but it is required to support the development of the process that will be transferred to GMP Manufacturing. A Repligen system will be used in GMP Manufacturing for the reasons listed below, and therefore the corresponding smaller scale lab system is required for this purchase.

Repligen are the only supplier of GMP Perfusion equipment that operates using Alternating Tangential Flow. There is no other commercially available system that can perform single use ATF style perfusion suitable for use in a GMP cleanroom. ATF style perfusion has been selected for this project as it is technically superior to the alternative TFF (Tangential Flow Filtration)-based or acoustic-based perfusion devices and there is wider industry adoption of ATF for use in bio-therapeutic manufacturing operations for this reason.

Alternative suppliers found from online searches have single-use TFF systems available such as the Sartorius Sartoflow 5000 SU TFF System, but these are not suitable for use in perfusion applications and are not proven to readily connect with Thermo Fisher Dynadrive bioreactors. Extensive re-engineering of BMIC existing systems would need to take place in order to interface these devices and even then it is unlikely to achieve the process intensity outputs required for a suitable reduction in the

cost of goods.