Continuous Chromatography System

Background
The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER)/Office of Pharmaceutical Quality (OPQ) needs to procure a Continuous Chromatography System with accessories. The solicitation number for this acquisition is 75F40124Q00135 for FDA Project CDER-OPQ-24-C-1575/CDER-2024-121574. This combined solicitation is being issued as a Request for Quotation (RFQ). This requirement is being solicited as a total small-business set-aside; only quotations submitted from small businesses will be considered for award.

Work Details
Continuous chromatography system abilities shall: have small footprint similar to 25” x 40”, due to limited bench space; be able to process 25-50L/day from a 50L perfusion bioreactor; have flexibility to switch between standard batch and continuous process modalities; shall contain pumps with pressure limit greater than 10MPa, flow rates up to 100 mL/min, and can run both isocratic and gradient elutions; have at least (two) 2 UV detectors and be able to monitor at least (two) 2 wavelengths at the same time (254 and 280 nm range); have at least (two) 2 conductivity sensors capable of measuring a range of 1-150 mS/cm; provide instrument controller with latest software and security updates; include a cart with lockable wheels for easy transport between labs and operation on the cart.

Period of Performance
Delivery of all equipment, accessories, installation, and training must be guaranteed less than 180 days after award date or accepted quote unless otherwise postponed by the U.S Food and Drug Administration (FDA). There will be a 12 (twelve) month period of performance of the manufacturer’s warranty which will commence the day of installation and training.

Place of Performance
Shipping and Installation Location: FDA/CDER/OPQR, 5901 Ammendale Road, Suite G, Beltsville, MD 20705