Description
Bioanalysis is the quantitative measurement of both small molecule drugs and large biomolecules in biological systems for the purpose of pharmacokinetics, toxicokinetics, bioequivalence, and/or pharmacodynamics studies. The Division of Applied Regulatory Science (DARS) executes a variety of internal and external studies including clinical and nonclinical pharmacokinetic-pharmacodynamic modeling, bioequivalence, drug metabolism and transport, in-vivo/in-vitro correlations, and drug-drug interaction studies bioanalytical analyses at both the clinical and pre-clinical levels. To support these projects, DARS currently utilizes five liquid chromatograph-tandem mass spectrometers (LC-MS/MS) from AB Sciex. Often these projects are of high-visibility, and mission critical (Opioids drug interaction, In-vivo conversion of ranitidine to carcinogen, sunscreens dermal absorption, cannabinoids, etc.) for the FDA leading to stringent deadlines and necessity for high quality data. We are also seeing an increased workload of internal in vitro projects aimed at evaluating microphysiological systems as appropriate tools for regulatory submissions. We are also providing bioanalytical support for a cross-center collaboration between CDER and CTP. As the drug development space moves towards biologics and biosimilars, it is important for DARS to equipped with the latest instrumentation necessary to analyze those products. Our current high resolution mass spectrometer is over 12 years old. The technology is obsolete. We are looking to replace our outdated technology with the ZenoTOF 7600+ LC-MS/MS system from AB Sciex. With this instrument we look to expand our analytical repertoire into the biologics and biosimilar realm. TECHNICAL REQUIREMENTS ZenoTOF 7600+ Mass Spectrometer • TwinSpray TurboV Source, • compatible with both ESI or APCI probes for automated calibration and allowing flow rates from 5 to 3000 ul/min (ESI) and flow rates from 200 to 3000 ul/min (APCI). • One standard roughing pump. • System ships with Data Acquisition Computer running Windows 10 64 bit • Standard Monitor. 4500 Triple Quadrupole Mass Spectrometer • Turbo V Source that accepts either the Turbo IonSpray Probe or APCI Probe. • Turbo IonSpray Probe: Heated IonSpray probe for use in the Turbo V Source. o Accepts flow rates from 5 to 3000 ul/min without splitting. • APCI Probe: Atmospheric Pressure Chemical Ionization probe for use in the Turbo V Source. •Accepts flow rates from 200 to 3000 ul/min. • System includes integrated syringe pump and 6 port, 2 position switching valve. • One standard wet pump kit (roughing pump). • System ships with Data Acquisition Computer running Windows 10 64 bit. • Standard Monitor. Liquid Chromatograph(s) 1290 Infinity II High Speed Pump • Operating range up to 130 MPa (1300 bar) up to 2 ml/min, 80 MPa (800 bar) at 5 ml/min. • Includes Active Seal Wash, Tool Kit, Solvent Cabinet, bottles and ISET. High speed UCT, Safe cap, Poroshell 120 EC-C18,2.1x50mm column. • Delivers a flow rate of up to 5mL/min., • A pH range 1.0 -12.5 • Low gradient delay volume of the pump (10 μL) • Flow Precision: ≤0.07% RSD or ≤0.005 min SD, whatever is greater. • Composition precision: ≤0.15% RSD or ≤0.01 min SD, whatever is greater. 1290 Infinity Multisampler • Up to 1300 bar for well plates and individual sample containers. • 1 sample drawer, 2x 54-vial containers, a needle flush port, 40 uL metering device, 20 uL loop. (For Dual-needle instruments metering is 100 ul and loop size is 20 ul), InfLab sample thermostat included, multi-wash option, with 3 Dual-height drawer kit. Sample Loop-Flex 40 uL right. • Capacity: Various and scalable drawer types from 2-16 well plates all within the LC-stack footprint • Carryover: 9 ppm using multi-wash option • Cycle Time: 10 seconds Injection cycle time for Single needle instrument. • Dual needle option: Two flow paths and delay volumes. Large and small sample loop volumes without HW change. • Injection Volume Range: 0.1 to 500μL or 1500 μL by seat loop extension • Linearity: By Dual-needle option from 0.1 to 500 μL R2 = 0.9999 1290 Infinity II Multicolumn Thermostat • Capacity up to eight columns with 10 cm length and a temperature range from 20°C below ambient to 110°C At least two independent temperature zones required. • 1.6uL Quick-Connect Heat Exchanger, Quick-Connect fitting and two Quick-Turn fittings. • Temperature range at high flow rate: 10°C below ambient to 100°C at up to 2.5 ml/min flow of pure Water and 10°C below ambient to 80°C at up to 5 ml/min flow of pure Water • Temperature accuracy must be ± 0.8 °C or ± 0.5 °C with calibration. Compatibility with existing Mass Spectrometer (MS) System • Shall be able to interface with Mass Spectrometer System (AB Sciex 4500 QTRAP) • Mass Spectrometer software (Analyst Software) shall be cable of controlling all LC components including pumps, autosampler, multicolumn thermostat, 2position/6 port valve and diode array detector. Period of Performance Delivery within 30 days of award. Installation within 30 days of delivery. Capabilities and Technical Experience: Provide a capability statement describing how your company would be able to meet the requirements. Business Status: Please provide your business size status (e.g., small business, 8(a), HUBZone, etc) and DUNS number. Disclaimer 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. Responses to the sources sought shall be no longer than 10 pages.