Sole_Source_-_FDA-SOL-1213457.pdf

FDA-SOL-1213457

Notice of Intent to Issue a Sole Source purchase order for a Protein Chemical Stability Analyzer with Accessories, Training plus four (4) optional years of Preventive Maintenance

The Food and Drug Administration (FDA) intends to issue a sole-source purchase order to Unchanged Labs at 6940 Koll Center Parkway, Suite 200 Pleasanton, CA 94566. The anticipated purchase order is for a high-throughput protein chemical stability analyzer that can perform the following applications and contain the following components/requirements.

1. Applications

a. Shall Dispense specified volumes of buffer, denaturant (up to 6M Guanidinium Chloride or 8M Urea), and protein to a specified well, and include a software implementation to automate the design of an experiment and provide user-friendly control of liquid dispensing.

b. Shall take fluorescence measurements of protein samples dispensed to plate with excitation at 280 nm and emission between 330-350 nm.

c. Shall provide analysis software implementation to automate the calculation of the concentration of denaturant at which ½ of protein is denatured, the barycentric mean, and the ΔG of a protein.

2. Accessories, Training, and Warranty

a. Shall include all necessary starter kits and software required to control the instrument and perform analysis outlined in applications.

b. Shall include Installation and Operational qualification

c. On-site training and installation

i) Installation shall include setting up machine and performing installation and operational qualification.

ii) Training shall include on-site application training for no more than 3 days

Preventive Maintenance shall cover all parts and installation for a base plus four optional years of service from installation date.

3. Technical Specifications Shall have fluorescence excitation source at 280 nm

Shall have fluorescence detection source capable of detecting wavelengths 300-720 nm and five orders of magnitude of fluorescence dynamic range Shall dispense buffer, denaturant, and protein to a single well of a 96 well or larger plate with a 1% accuracy on dispensation for volumes between 10 and 200 uL

Shall have sample tray capable of handling a variety of options for sample size of at least 96 samples in parallel Shall operate on a 110-240 V line Shall be able to maintain a temperature of 4°C for the protein prior to analysis Shall be capable of being placed on a countertop (<2.5 ft x 2.5 ft base) The instrument shall be built of materials capable of handling the denaturants 8M Guanidinium Hydrochloride and 8M Urea without causing corrosion to instrument.

Award will be made in accordance with Federal Acquisition Regulation (FAR) Part 6.302-1, only one responsible source and no other supplies or services will satisfy the agency requirements using Simplified Acquisition Procedures per FAR Part 13.5. This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within seven (7) days after the publication of this synopsis, which will be considered by the agency. Responses received after seven (7) days or without the required information may not be considered. A determination by the Government not to compete thus, of information received is solely within the discretion of the Government. Information received will be considered solely for determining whether to conduct a competitive procurement. For information concerning this acquisition, contact Linda Troutman, Contract Specialist at Linda.Troutman@fda.hhs.gov