Chromatography System/Option Years

Objective FDA has the need for an instrument a Continuous Chromatography System (ContiChrome Cube Combined, or equivalent) with accessories and service options. The Office of Biotechnology Products requires the purchase of a multiple column (or continuous) chromatography system capable of performing simulated moving bed and/or periodic counter-current chromatography processes. To include option year maintenance of 1 base period of one (1) year and four (4) one (1) year option periods. Our goals are two-fold: 1) to continually purify harvested cell culture fluid from perfusion bioreactors, and 2) to investigate and understand the technology to provide knowledge feedback in support of regulatory findings. CLIN Description Price 0001 Chromatography System $ Training/Installation $ Shipping $ 1001 Option Year 1 $ 2001 Option Year 2 $ 3001 Option Year 3 $ 4001 Option Year 4 $ Total Cost $ Technical specifications Continuous chromatography system abilities Must have small footprint similar to 25” x 40”, due to limited bench space Must be able to process 10L/day from 6 separate reactors, for a total of at least 60L of material from our perfusion bioreactor cell cultures Must have flexibility to switch between standard batch and continuous process modalities Must be capable of performing CaptureSMB for antibodies Must be capable of performing in-line dilution Must be capable of performing online enrichment for product-related impurities Must contain pumps with: pressure limit greater than 10MPa flow rates up to 100 mL/min can run both isocratic and gradient elutions Must have at least 2 UV detectors and be able to monitor at least 2 wavelengths at the same time (254 and 280 nm range) UV detectors should be capable of automated dynamic feedback control to control valve switching/column loading Must have at least 2 conductivity sensors capable of measuring a range of 1-150 mS/cm Must contain a refrigerated (cooled) fraction collector Must provide instrument controller with latest updates Must use 120V outlet Requirements Service should be included as 1-year option years that can be purchased for up to 4 years after base award. Plan to include at least 1 PM and all repairs for 1 calendar year Must include all travel, labor, and parts Special Requirements Only certified field technicians must be used for installation and training, maintenance Must be able to provide any needed parts, labor, and travel for repair in a timely fashion (3-7 days) Scheduling must be Monday-Friday between the hours of 9am-4pm. Scheduling to be coordinated through the TPOC on the contract. All technicians must have a valid U.S. Driver’s license for entry through security delivery/Installation U.S. Food and Drug Administration 10903 New Hampshire Ave Bldg 52/72 Rm 2334 Silver Spring, MD 20903 Installation will be considered complete once all installation qualification tests have been successfully completed and all passwords and usernames have been set up and provided to the FDA 1 to 3-day On-site training should be included in the price Factory Warranty should cover all parts and installation for at least 1 year. Period of Performance Delivery of the instrument should be within 60 days of contract award. The period of performance shall be 1 year from the date of delivery and installation to ensure proper establishment of the system warranty.