Repligen Corporation Alternating Tangential Flow (ATF) Perfusion System with 5L Benchtop Glass Bioreactors replacement Controllers and Accessories.

The FDA's Center for Drug Evaluation and Research (CDER) intends to award a single-source purchase order to Repligen Corporation for essential components of its Alternating Tangential Flow (ATF) Perfusion System. This acquisition, under FAR RFO 6.103-1, is necessary because Repligen is the sole responsible source capable of providing 100% compatible replacement parts and ensuring system integrity. The existing ATF Perfusion System, crucial for continuous biomanufacturing of protein therapeutics, requires new controllers and various other components manufactured by Repligen. Introducing non-Repligen parts would void warranties and service agreements. The FDA has not identified any other suppliers for these specialized components, reinforcing the single-source determination. Firms believing they can provide these items may submit capability statements by May 27, 2026.