MODIFICATION
66 -- Instrument, Optical Protein Interaction
- Notice Date
- 8/12/2013
- Notice Type
- Modification/Amendment
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Other Defense Agencies, TRICARE Management Activity, USUHS CONTRACTING OFFICE, 4301 JONES BRIDGE ROAD, Bethesda, Maryland, 20814-4799, United States
- ZIP Code
- 20814-4799
- Solicitation Number
- HT9404-13-Q-0673
- Archive Date
- 9/14/2013
- Point of Contact
- Steve H. Beck, Phone: 301-295-3970, Christina Johnson, Phone: 301-295-3069
- E-Mail Address
-
Steven.Beck@usuhs.mil, chrisitna.johnson@usuhs.edu
(Steven.Beck@usuhs.mil, chrisitna.johnson@usuhs.edu)
- Small Business Set-Aside
- Total Small Business
- Description
- ****Start of Amendment 0002**** The purpose of this amendment is to: 1) Extend the deadline to request our test. 2) Advise on the Government's intent on when the Contractors should conduct the tests. 3) Clarify a few points on the test --- 1) The deadline for the contractors to request the test and provide us with all of our required information has changed from August 12, 3pm Eastern Time, to August 13, 10am Eastern Time 2) The Vendors who RSVP should receive the test and test samples by close of business August 15. The Vendors have until August 19, 12:00 to submit questions to the Government. It is our intent, that the vendors will wait until after we answer the vendors questions (on or about 12:00 Eastern Time, August 22), before they commence with the tests. 3) Vendors can use whatever coupling scheme works best for their instrument. We listed the details regarding how these samples were studied (prior to our decision to purchase an instrument), only in the interest of giving the vendors a complete picture of how we acquired our data. We are aware different vendors use different units along vertical axis of their kinetic data plots; kinetic (and binding) constants obtained (and goodness of fit (which, of course, can be related to sample quality)) are more of interest. Regeneration is not required as a part of the demonstration. We are interested in how reproducible the data is for using a biosensor w/ multiple samples, so looking at the background signal after rinsing off analyte (during measurement of off-rate) and the data from binding to a new aliquot of analyte helps us make that evaluation. Molecule C in demonstration part i) has a MW of 75 kDa. Kinetic constants and Kd values for the samples in both demonstration parts i) and ii) have been previously measured; the Kd range for demonstration part i) is 100 nM to 10 uM (note decrease in upper limit for Kd), the Kd range for demonstration part ii) remains as previously stated (10 - 100 pM). The MW of the FAb in demonstration part ii) is about 150 kDa. ****End of Amendment 0002**** ***Start of Amendment 0001**** The purpose of this amendment is to: 1) Advise we will accept a recondtioned or refurbished item. 2) Advise we have replaced the on-site demonstration, with a vendor adminstered test to be conducted at the vendor's location. By August 12, 3pm Eastern Time, please indicate if you want the test, along with the make and model of your tested item. If two vendors are offering to test on the same machine, the first vendor will receive the test sample. You will be required to run tests on: i) binding and kinetic analysis of a protein-protein interaction with a Kd in the range of 100 nM to 10 uM ii) binding and kinetic analysis of an antigen-antibody interaction with a Kd in the range of 10 to 100 pM The third test (from the original RFQ) has been eliminated. Here is additional information on the two tests: In the interest of achieving an adequate demonstration of instrument performance, vendors are invited to run tests i) and ii) in their applications laboratory using Government-supplied ligands and analytes and submit acquired data/results by the RFQ's closing date and time. Test i) will require the immobilization of two commercial recombinant proteins (Prot. A: MW ~85 kDa, Prot. B: ~66 kDa) via amine coupling to biosensors. These proteins have been purchased by customer; vendor should indicate how much material is required for immobilization. The free analyte to be tested is a protein prepared by the customer (Prot. C: MW ~ kDa); its Kd is in the range previously specified in the test i) description (100 nM to 10 uM). VENDOR MUST INDICATE HOW MUCH ANALYTE IS REQUIRED FOR KINETIC/BINDNIG EXPERIMENTS. The vendor is welcome to use running/binding buffer and regeneration buffer that they feel will work best with their instrument (previous results were obtained using a running buffer of HBS-EP (0.01 M HEPES pH 7.4, 0.15 M NaCl, 3 mM EDTA, 0.005% v/v Surfactant P20) and a regeneration buffer of 10 mM glycine-HCl pH 2.0); if the free analyte must be in a vendor-specified buffer for demonstration, vendor must inform customer and provide if proprietary. Test ii) Kinetics and binding of wild-type and mutant proteins (18 kDa) interacting with an immobilized monoclonal antibody Fab fragment: (Note: The text below has been extracted from a manuscript describing characterization of proteins binding to a monoclonal antibody Fab. The experiments were carried out on Biacore T100 and T200 instruments. These experiments represent some of the epitope mapping approaches used by my laboratory. Please note the long dissociation phase for this antibody-antigen complex. Vendors should either covalently attach the Fab to their biosensor (conditions for previous assays described below), or else carry out a similar experiment using a full-length murine monoclonal antibody captured on a biosensor with the relevant anti-Fc antibody already attached. Samples will be three Antibodies (IgG ~150 kDa) and three proteins (antigens ~18 kDa).) VENDOR MUST INDICATE HOW MUCH ANTIBODY THEY REQUIRE FOR IMMOBILIZATION AND HOW MUCH ANTIGEN THEY REQUIRE FOR KINETIC/BINDING ASSAYS. Materials and Methods: Epitope mapping: SPR measurements were carried out on Biacore T-100 and T-200 instruments (GE Healthcare Life Sciences, Piscataway, NJ). The Fab fragment was immobilized covalently on a CM5 chip (GE) by amine derivatization, following the manufacturer's suggested protocol. The Fab fragment (3.9 mg/mL) was diluted 200-fold in 10 mM sodium acetate pH 5.0. The Fab was immobilized by amine coupling, using 1-Ethyl-3-(3-dimethyl-aminopropyl)carbodiimide-HCl and N-hydroxysuccinimide (GE) to activate the CM5 surface, then injecting the protein serially in Running Buffer HBS-EP+ (GE) until 300 +/- 5 resonance units (RUs) corresponding to immobilized protein were recorded, at which point 35 microliters ethanolamine was injected to quench reactive sites on the chip. This immobilization level yielded Rmax values between 30 and 100 RU. These relatively low values circumvented potential complications associated with mass transport limitation, which were a concern due to the high association rate of the complex. A reference flow cell was created by activating and then immediately deactivating the sensor surface without exposing it to the Fab. Analyte proteins having single alanine substitutions at surface positions at 0.4 to 50 nM were injected for at least 120 seconds, and dissociation was monitored for 300-900 seconds to determine association and dissociation rate constants, respectively. All experiments were carried out at 25°C. Regeneration of the biosensor surface was accomplished by injecting 10mM glycine-HCl, pH 2.0 (GE) for 30-60 seconds and resonance signals were monitored to ensure complete dissociation of analyte protein before initiating the next experiment. The sensorgrams were subtracted from the reference cell signal, subsequently subtracted from a blank run signal and then subjected to curve fit analysis using Biacore Evaluation Software version 2.0.1 using a 1:1 binding model. Results: Epitope Mapping: Several analyte proteins tended to precipitate and were therefore stored at concentrations below 0.2 mg/mL; their concentrations were verified by a BioRad DC microplate assay immediately before dilution for SPR runs. Analyte binding to the reference cell was not detected. Occasionally, the sensorgram corresponding to the highest concentration was omitted from analysis due to apparent non-specific binding, but in these cases the binding curves at lower analyte concentrations were adequate to calculate reliable rate constants. The dissociation constants (kd) were selected as the most reliable metric to follow in comparing effects of amino acid substitutions, as they differed more than the association constants or the calculated affinities, KD, among this set of antibody-antigen complexes. Five SPR runs were carried out to determine average kinetic constants for WT-analyte binding to the immobilized Fab. The kinetic constants were the same (within a factor of 2) for association periods of 120 or 300 seconds and for dissociation periods of 900 or 1800 seconds. Two analyte muteins showed virtually no binding to the immobilized Fab. Curve fits for these mutants revealed a maximum resonance signal (Rmax) 12% of the Rmax for the wild-type analyte. In contrast, all other muteins had Rmax levels comparable to that of the wild-type analyte, indicating they were capable of binding Fab. We will send you the test via overnight mail o/a August 13. Your test results must be delivered to the Contracting Office by the RFQ's closing date and time. Late test results will result in a technically unacceptable quote. Results to be submitted w/ Quote: Plots of k(on), k(off) for each concentration used, calculated Kd. 3) The quote evalution process has changed to the following: (in order of importance) a) Tech Eval (in order of importance) (1) pass the test (failing the test automatically disqualifies your product) (2) content and merit of submitted product literature (including applications notes and published results in the scientific literature by non-vendor users of instrument), as it compares to the details outlined in the minimum specifications, track record in the scientific literature, (technical team may perform their own research on the product's track record) (3) warranty coverage and length, coverage of service maintenance agreement b) Overall price - we may award up to CLINS 0001-0004, but we will factor in the cost of CLIN 1001 (warranty) as part of our price evaluation 4) The deadline to ask questions is now August 19th at 12:00 pm Eastern Time. We plan to publish an amendment on or about August 22nd Eastern Time. *****end of Amendment 0001***** Note: This requirement was previously solicited under HT9404-13-Q-0672. If you submitted a quote to HT9404-13-Q-0672, you must send a new quote. The Uniformed Services University of the Health Sciences (USUHS) is the Nation's federal health sciences university and is committed to excellence in military medicine and public health during peace and war. We provide the Nation with health professionals dedicated to career service in the Department of Defense and the United States Public Health Service and with scientists who serve the common good. We serve the uniformed services and the Nation as an outstanding academic health sciences center with a worldwide perspective for education, research, service, and consultation; we are unique in relating these activities to military medicine, disaster medicine, and military medical readiness. USUHS is located in Bethesda, MD on the grounds of the Naval Support Activity Bethesda. This is a combined synopsis/solicitation for commercial items in accordance with the format in 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 written solicitation will not be issued. This is a request for quotes (RFQ) for commercial items in accordance with the procedures of FAR Part 12 - Acquisition of Commercial Items and FAR Part 13 - Simplified Acquisition Procedures. This RFQ incorporates all provisions and clauses in effect through Federal Acquisition Circular (FAC) 2005-66 (effective 1 April 2013) and Defense Federal Acquisition Regulations Supplement Publication Notice (DPN) 20130228 (effective 12 April 2013). This requirement is set-aside for small business concerns under NAICS code 334516 (Analytical Laboratory Instrument Manufacturing) with a size standard of 500 employees. An offeror's size standard will be verified in www.SAM.gov. In order to be eligible for award, offerors must be registered in www.SAM.gov, with completed representations and certifications, prior to award. Offerors interested in responding to this requirement must provide an optical protein interaction instrument which, at a minimum, meets the specifications listed below. This is a firm-fixed price requirement. Your price quote must be valid through September 30, 2013. USUHS has a requirement for one (1), Optical Protein Interaction Instrument. A real-time analysis instrument to quantify biomolecular and small molecule interactions, including thermodynamic and kinetic analyses of binding. The instrument will be used to study protein and small molecule interactions and binding. We will accept quotes for reconditioned items. Price: The contractor must provide pricing as set up below: Contract Line Item Number (CLIN), description, and unit of issue. Your offer is based on meeting the established minimum specifications. CLIN 0001 Real-Time Analysis Instrument 1.00 EACH______________ CLIN 0002 Installation 1.00 JOB ______________ CLIN 0003 Training 1.00 JOB ______________ CLIN 0004 Delivery 1.00 EACH _____________ CLIN 1001 Option - Annual Service & 1.00 YEAR _____________ Maintenance MINIMUM SPECIFICATIONS This requirement is for the purchase, delivery and installation of the real-time analysis instrument. The specifications are as follows: Bench top Kinetic, affinity, and steady state analysis (kobs, ka, kd, KD) Binding specificity and binding cooperativity Real-time binding of protein interactions, protein complexes, and inhibitor effects Biomolecule types: proteins, antibodies, peptides, nucleic acids, lipids, and small molecules (drugs, metabolites, etc.) Sample types: purified biomolecules, serum, plasma, and cell culture supernatants, up to 10% DMSO Software for thermodynamic analysis and immunogenicity assays, including anti-drug antibody characterization Typical sample volume: in the range of 50-1000 L Must be able to reliably measure ka values up to 107 M-1s-1 and KD values down to 10-100 pM. Compatible with Windows XP or Windows 7 Annual Service & Maintenance - The Government requires pricing on a one-year service contract, in addition to the warranty. Contractor will provide all labor, parts, materials, tools, and transportation to repair the equipment. In addition, contractor will provide technical and application support and operational assistance to Government on an as-needed basis via phone and on-site assistance. EVALUATION FACTOR(s) The government will award a firm-fixed-price (FFP) contract resulting from this solicitation to the responsible offeror whose offer conforms to the combined synopsis/solicitation, and is most advantageous to the government, based on the following evaluation factors in order of importance: 1. Technical A. Offerors must provide product literature which demonstrates the capabilities of the quoted item(s). At a minimum, the product literature must demonstrate that the quoted item(s) meet the minimum specifications identified. B. A demonstration of the performance of vendor's instruments will be required, consisting of the following tests: i) binding and kinetic analysis of a protein-protein interaction with a Kd in the range of 100 nM to 10 uM ii) binding and kinetic analysis of an antigen-antibody interaction with a Kd in the range of 10 to 100 pM iii) binding and kinetic analysis of a small molecule-protein interaction w/ a range of 0.1 to 100 uM Vendors will supply the biosensors and coupling reagents needed for the demonstrations; government researchers to supply the proteins and small molecules. Note on Demonstrations: The Demonstrations will take place at the main USUHS campus on August 13 or 14th. The Demonstration time blocks are: August 13 9am to 11 am August 13 11:30am - 1:30pm August 13 2pm to 4pm August 14 9am to 11 am August 14 11:30am - 1:30pm August 14 2pm to 4pm You must e-mail Steve Beck at steven.beck@usuhs.mil by 3pm Eastern Time Wednesday, August 7 with your top 6 time slot choices in order of preference. Time slots will be filled in the order they are received. Vendor will be notified of their time slot by 3pm Eastern Time, August 8, 2013. We will not evaluate the same product from two different dealers/manufactures. The first vendor to secure an appointment will give the demonstration. Since the demonstration is an integral part of the evaluation process, a quote on a non-demonstrated product will be deemed technically unacceptable. C. Information warranty must be included in the quote submission and will be evaluated. The contractor must provide a copy of their service maintenance agreement. Technical acceptability will be determined based on the content and merit of submitted product literature (including applications notes and published results in the scientific literature by non-vendor users of instrument) as it compares to the details outlined in the minimum specifications, track record in the scientific literature, (technical team may perform their own research on the product's track record), the results of the demonstration, and warranty/service contract information. 2. Price Offerors must include all applicable costs (example: accessories, shipping, warranty) in their quote. The total quoted price for all components will be the evaluated price. 3. Delivery The performance completion date after receipt of order (ARO). The desired delivery date is 90 days ARO. The Government reserves the right to award without discussions. The Government reserves the right to issue an award without including all CLINs. See attached list for applicable provisions and clauses for this requirement. Questions/clarifications regarding this solicitation must be submitted via email to steven.beck@usuhs.mil by August 15th, 3pm Eastern Time. Any questions received after that time will not be answered. Questions will not be answered over the phone or submitted by any other means. All questions will be answered in an amendment to the solicitation posted on or around August 20, 2013. Quote packages are due by 9:00 AM Eastern Time August 30, 2013. Quotes must be submitted via email to will not be accepted by any other means. Late quotes will not be considered. Quote packages should include a cover sheet with the following information: • Company Name • HUBZONE Certified? (If Yes, submit documentation with your quote) • Point of Contact, to include email and phone number • DUNS Number • Tax-ID Number • Statement that includes acknowledgement of latest amendment number • Item's country of origin • Will you accept VISA for payment? Without a credit card fee? • Have all discounts been applied? • Lead time upon receipt of the purchase order
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/cdb13d1d9a9feaed0d07d57ddce12f07)
- Place of Performance
- Address: Uniformed Services University, Bethesda, Maryland, 20814, United States
- Zip Code: 20814
- Zip Code: 20814
- Record
- SN03145530-W 20130814/130812235015-cdb13d1d9a9feaed0d07d57ddce12f07 (fbodaily.com)
- Source
-
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