SOLICITATION NOTICE
66 -- Tribute Peptide Synthesizer “Brand Name or Equal” - FDA-RFQ-1169411
- Notice Date
- 6/20/2016
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-RFQ-1169411
- Archive Date
- 7/15/2016
- Point of Contact
- Lisa K. Yaw, Phone: 2404024018
- E-Mail Address
-
lisa.yaw@fda.hhs.gov
(lisa.yaw@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- The U.S. Food and Drug Administration’s (FDA Center for Biologics Evaluation and Research (CBER) has a requirement new Tribute Peptide Synthesizer or equal. Part 1 - Description The U.S. Food and Drug Administration's (FDA Center for Biologics Evaluation and Research (CBER) has a requirement new Tribute Peptide Synthesizer or equal. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued. This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-86. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing. The associated small business standard is 500 employees. This requirement is for a small business set-aside. Part 2 - Supplies or Services and Prices/Costs Purchase Order Type: Firm-Fixed Price Base Year ManufacturerItem No.DescriptionPrice Protein TechnologiesTPS-110TRIBUTE® - Automated 2 Channel, Solid-Phase, Bio-Organic Synthesizer (115 VAC, 60 Hz), with Semi-automated cleavage. Complete with embedded computer, TRIBUTE® software, touch-screen Complete with embedded computer, TRIBUTE® software, touch-screen monitor and cables, PTI Peptide Predictor software, safety shield, 20 Liter single waste container, safety-coated solvent bottles, 12 collect tubes Protein TechnologiesTPS-INSTALLOnsite installation and training for 2 days by a PTI trained technical support person, including running verification test peptides and test peptide AA), Reaction Vessels (30 x 10 mL disposable reaction Protein TechnologiesTPS-STARTKITTribute start-up kit, complete with 98 pre-filled AA bottles with activator, Fmoc-L-Gly Wang Resin, Rink Amide MBHA Resin Protein TechnologiesTPS-UV-OPTTwo-Channel On-Line Intelli-Synth TM UV Monitoring and Feedback Synth TM UV Monitoring and Feedback control system and software Protein TechnologiesTPS-IR-OPTTwo individually controlled IR heating unit, with software and heating control systems Protein TechnologiesTPS-CLV-OPTCleave/Collect Assembly Protein TechnologiesPPS-RV-PREPSTATPrelude/Tribute Reaction Vessel Preparation Station Protein TechnologiesTPS-TXT-EML-RPTRemote Synthesis Report Options Protein TechnologiesTPS-USR-WRK-UTLUser Workstation Utility shipping Installation and training One (1) year warranty on parts, labor, and travel Total Option Years Option YearDescriptionPrice 1Service Agreement 2Service Agreement 3Service Agreement 4Service Agreement Total Firm Fixed Price The total price for the base and four option years is $____________. Part 3 - Description/Specifications 3.1 Background The Facility for Biotechnology Resources (FBR) of the Center for Biologics Evaluation and Research (CBER) provides an array of services, including the synthesis of peptides for scientists at CBER and CDER. Peptides are utilized in research ranging from studies of protein-protein interactions, regulation of cell functions, to development of vaccines to flu, pertussis or tetanus viruses and other infectious organisms. Crude peptides are synthesized at FBR using peptide synthesizers and 20 amino acids in fully automatic chemical coupling reactions. The current instrument in place is very old and no longer supported by the manufacturer, therefore a new instrument is required. 3.2 Statement of Work/Salient Characteristics Scientists at CBER and CDER conduct cutting-edge studies in order to elucidate molecular mechanisms of proteins/peptides functions in living organisms or to combat infectious agents such as flu, pertussis, tetanus viruses and microorganisms through the development of effective vaccines. Often these studies require synthetic peptides as ligands for studying signal transduction, biochemical mechanisms, and as antigens for vaccine development. Peptides are currently synthesized at FBR using Applied Biosystems 433 single-vessel synthesizers. These synthesizers deliver chemicals to a reaction vessel where coupling between two amino acids occurs. In short, each coupling reaction involves de-protection of FMOC group of the amino acid on a resin using a weak base, followed by activation of carboxylic group of the incoming amino acid, coupling of peptide bond, and washing to remove excessive reagents. In essence, the synthesizer provides fluid delivery, mechanical agitation of the reaction vessel, and the advancing of vials containing amino acids according to synthesis sequence. The current instrument used for synthesis is no longer supported by the manufacturers. Therefore a new dual-channel peptide synthesizer is required from a vendor currently manufacturing and supplying peptide synthesizer with updated technologies. A dual-channel solid-phase peptide synthesizing system, with semi-automated cleavage with the following specifications are required: 1.A fully automated solid phase peptide synthesizer supporting FMOC and tBoc chemistries and require 110V power supply. 2.Synthesis scale range between 5 µmol and 2 mmol. 3.Provides 2 independent reaction vessels allowing simultaneous synthesis of two completely different peptides with different scales. 4.Use two independent UV monitoring systems for each reaction vessel and two IR heating source for each reaction vessel. 5.Shall have user programmable/selectable top-down and bottom-up solvent deliveries and washing. Shall have fixed loop liquid measurement techniques with optical sensors ensuring accurate deliveries irrelevant of viscosity changes etc. 6.Shall have user selectable mixing modes- such as adjustable nitrogen bubbling, adjustable vortexing and combination of both. 7.Shall have on board barcode scanner for AA vials / cartridges-allowing to keep records and to put any AA at any position. 8.Shall have flexible stop, start, and pause and restart functions for interrupted synthesis-allowing to add special reagents. 9.Shall have built in computer and must have built-in full color, TFA (trifluoroacetic acid)- resistant touch screen, and software etc. 10.Shall have reporting of real time log of each instrument function, printing to file, screen or printer. 11.Shall have on board diagnostic and error reporting and reaction to the error. For example, when synthesis is interrupted due to any reason, it should drain the active reaction vessel and wash the resin with solvent of our choice and repetition automatically to prevent side reactions, and undesired by products to save chemistries & time and reagents etc, and must also inform user by e-mail. 12.Software shall have has all the controlling and operating and reporting facilities as per GMP / GLP norms, and in addition all the calculations etc and must also have capability to calculating the coupling difficulty for any peptide sequence. 13.Shall limit access to authorized users / individuals with different access right by electronic signature and passwords. 14.Shall have on board fully automated and programmable cleavage facility for at least FMOC chemistries. 15.Shall have onsite installation and two days instrument training. 16.Shall include a start-up kit to validate the function of the instrument. The instrument shall perform the following: 1.Delivery, Installation, Training and Warranty: •Installation shall include of the installation of the system and all components, as well as calibration, quantification, and software installation •Shall include a demonstration/training for lab personnel •Shall include a warranty for at least one (1) year from date of installation which covers all labor, parts, and travel expenses required for repairs for equipment and software. Technical support and troubleshooting assistance shall be provided via phone, email, or live-chat interface. 3.3 Optional Service Agreement The FDA shall have a unilateral right to exercise optional periods to continue the service agreement described below: The offerors pricing for optional service agreement shall include coverage of labor, parts and travel expenses. Parts- The service plan will use Original Equipment Manufacturer (OEM) certified parts. Services On-Site- The contractor will initiate corrective maintenance/repairs within 48 hours from the service call. The repairs will be completed within 72 hours from the on-site arrival of the technician/service engineer. There will be no limit to the number of on-site repair service visits. The service shall be delivered by an authorized OEM service provider. Services Off-Site- Technical support and troubleshooting assistance will be provided by the contractor via phone, email, or live-chat interface within 1 hour of initial contact. Part 4 -Performance and Deliverables 4.1 Place of Performance and Work Hours All applicable equipment is located at the location listed below. Normal workdays are Monday through Friday except US Federal Holidays. Work hours are typically from 8 am to 5 pm (et). Service visits shall be coordinated with TBD, see below. Location and Point of Contact: Food and Drug Administration CBER/OD/FBR White Oak Campus Building 52/72 Room 1106 10903 New Hampshire Ave Silver Spring, MD 20993 ATTN: TBD The system will be delivered to the address above for assembly, installation, and onsite training. 4.2 Period of Performance The equipment shall be delivered by September 1, 2016. The warranty shall start when equipment is installed and accepted by FDA and be in effect for one year. The period of performance shall be September 1, 2016 to August 31, 2017. Optional Periods DeliverablePeriod of Performance Option Period 1 -Service AgreementTo begin 1st year following receipt of equipment Option Period 2 -Service AgreementTo begin 2nd year following receipt of equipment Option Period 3 -Service AgreementTo begin 3rd year following receipt of equipment Option Period 4 -Service AgreementTo begin 4th year following receipt of equipment
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-RFQ-1169411/listing.html)
- Place of Performance
- Address: Food and Drug Administration, CBER/OD/FBR, White Oak Campus, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04155022-W 20160622/160620234123-5db4c119f6d7091435cba404266cdad9 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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