SOURCES SOUGHT
66 -- Downstream Development Biolayer Interferometer Instrument: GatorPivot 16 Channel and Gator Pro 32 Channel Systems- Brand Name or Equal
- Notice Date
- 8/2/2024 1:47:46 PM
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- NIAID-SS-24-2224320
- Response Due
- 8/2/2024 12:00:00 PM
- Archive Date
- 08/17/2024
- Point of Contact
- Hershea Vance, Phone: 3017616404, Linda Smith, Phone: 2402369341
- E-Mail Address
-
hershea.vance@nih.gov, linda.smith2@nih.gov
(hershea.vance@nih.gov, linda.smith2@nih.gov)
- Description
- Introduction This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. � Project Summary A. The National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Production Program (VPP) of the Vaccine Research Center (VRC) is seeking a Biolayer Interferometer Instrument to support monoclonal antibody and vaccine projects. Specifically, NIAID, VRC is seeking one (1)� GatorPivot 16� (SKU 110055) system and one (1) GatorPro 32 Channel (SKU 110033) system (Brand Name or Equal) to meet the specifications and perform the following applications listed below.� Instrument #1: Salient/Key Requirements for Downstream Development Biolayer Interferometer: Biolayer Interferometer (BLI): A BLI instrument is required to support the development of vaccines at the VPP.� The BLI is used for high-throughput quantification of specific proteins and protein epitopes of interest from samples obtained during protein purification development.� The BLI is used in conjunction with automated liquid handlers to rapidly screen purification procedures for specific desired protein antigens and tune purification conditions to exclude misfolded protein antigens that would hinder the resultant vaccine efficacy. The ability to isolate proteins of interest while controlling contaminants is critical to gaining regulatory approval of the vaccine candidates. Acceptable size dimensions: Rigid limits of 79 cm in length x 87 cm in width x 92 cm in height for the equipment, potential key add-ons, and other key components combined. These dimensions are required due to the physical size constraints needed to integrate the instrument to an automation platform. Power requirements: No more than 2x 220V plugs due to the power constraints of the lab. Integration capability: ��Integration our liquid handling instrumentation is required to maintain the high throughput purification and analysis pipeline that is currently established.� Integration allows for hands-off data generation and ability to process samples quickly and efficiently. Kinetics Assay Specifications: These specifications are required to perform accurate binding assays with a BLI instrument during downstream process development. Maximum sample capacity per run: 816 Molecular weight cutoff: >150 Da. We will be typically assaying proteins larger than 150 Da in size. Association rate range: 10-107 M-1s-1 Dissociation rate range: 10-6-10-1 s-1 Measured affinity constant: 10 pM �1 mM. These are standard affinities measured during process development. Epitope Binning Capacity: 20x20 Baseline noise: ? 4 pm. Minimal baseline noise is required for good curve fitting and processing of low nm shift on the instrument. Baseline Drift: ? 0.1 nm/hour. Minimal baseline shift is important over long assays greater than 1 hour. Acquisition rate: 2, 5, and 10 Hz acquisition. Variable acquisition is necessary due to the wide range of kinetics interactions observed during downstream development. Temperature control: Temperature control ranging from 15�C to 40�C is required for ability to complete temperature dependent experiments.�� Minimum Sample Volume: A minimum volume of 40uL is required to minimize lost sample due to analysis. User friendly analysis software: Intuitive and user-friendly interface required for ease and flexibility in data analysis.� Ease of export of raw data for other software analysis. The built-in analysis software should be as transparent as possible, showing curve fits and fitting parameters. The software should also be installable on other computers to allow for remote data analysis. Large range of biological sensors with high sensing dynamic range: Protein A, Protein G and Protein L sensors: 0.02-2,000 ug/mL. Human fC sensor: 0.05-300 ug/mL. Ni-NTA sensor: 0.25-1,000 ug/mL. Anti-PEG biosensors:� Required for process development of lipid nanoparticle-based vaccines.� Low Coefficient of Variation across all concentrations: Probes are required to have less than 10% variability in sample reads at all concentrations. This is extremely important for low concentration assays. Minimal loss of signal due to regeneration: Regeneration of probes is used to reduce the cost and time to perform each experiment. Probe regeneration should minimize loss of binding signal to less than 10% per regeneration. Simultaneous read capacity: Simultaneous read of both 8 and 16 channels is required and allows for flexibility in experiment design.� Evaporation Control:� Evaporation control is required as evaporation of samples as can lead to inconsistencies in results and unreliable data. � Microplate format:� Required to support both up to two 96 and 384 well microplates simultaneously. Probe Tray Evaporation Reduction: The probe tray should also prevent evaporation of probe buffer by allowing the probes to make a seal in the well, extremely important for long experiment times. B. Instrument #2 Salient/Key Requirements for Downstream Analytical Development Biolayer Interferometer: Type of samples: Should be compatible to analyze proteins, antibodies, peptides, nucleic acids, liposomes, viruses, and small molecules. Reading capacity: Should be able to simultaneously read and analyze up to 32 samples. � High through-put and sample capacity. Should be high through put with high sample testing capacity of greater than 1000 samples per batch with binning capacity of up to 32 parallel competitive reactions. Sample molecular weight and volume: Should be able to test samples with molecular weight greater than 150 Da with minimal sample volume of less than 50 ?L. Kinetics and quantitation capability:� Should be able to analyze following kinetics parameter range: (1) Association rate (Kon) of 101 to 107 M-1s-1. (2) Dissociation rate (Koff) of 10-6 to 10-1 s-1. (3) Affinity constant of (KD) of 10 pM � 1 mM. (4) Quatitation range of 0.02 � 2000 ?g/mL. Spectrometer and plate capacity: Should have at least 32 spectrophotometer which is capable to read and analyze 96-well and 384 well plate formats. Anticipated Period of Performance It is anticipated that an award will be made on or about October 01, 2024. Delivery of equipment will be required as soon as possible. Capability Statement/Information Sought If your organization has the potential capacity to provide a Biolayer Interferometer Instrument which meets the minimum salient characteristics listed above, please provide the following information: Organization name, address, point of contact, email address, website address, telephone number, UEI number Type of business (e.g., 8(a), HUBZone, Other than Small, etc.) pursuant to the applicable NAICS code Identification of any Best-in-Class contract vehicles including Government Wide Acquisition Contracts (GWAC) (e.g., GSA schedule, NITAAC) they may possess or are aware of that would support this possible requirement. If your organization does not provide the products/services under a GWAC, please identify availability as OPEN MARKET ONLY. Tailored capability statement addressing the capability of the instrument to meet NIAID�s minimum salient characteristics. Capability document shall be no more than six pages. Place of manufacture for the Biolayer Interferometer Instrument and if applicable, any accessories/components. Evidence that the organization is an authorized reseller or manufacturer of the instrument. Only Original Equipment Manufacturer (OEM) products are acceptable. � Submission Instructions Interested businesses who consider themselves qualified to provide the above listed Biolayer Interferometer Instrument are invited to submit a response to this Sources Sought Notice by August 12, 2024, at 3:00 PM EST. All responses under this Sources Sought Notice shall be emailed to Hershea Vance at hershea.vance@nih.gov. Disclamer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization�s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. �However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/d7f02d324a8e438787979d0da25ed6a5/view)
- Place of Performance
- Address: Gaithersburg, MD 20878, USA
- Zip Code: 20878
- Country: USA
- Zip Code: 20878
- Record
- SN07155258-F 20240804/240802230123 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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