SOLICITATION NOTICE
66 -- Parallel Bioreactor System
- Notice Date
- 4/8/2011
- 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, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 11-223-SOL-00074
- Archive Date
- 5/5/2011
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This requirement is being issued in conjunction with FAR 13.5 Test Program for Certain Commercial Items, as applicable. The solicitation number is 11-223-SOL-00074. This solicitation is issued as a Request for Quote (RFQ). Funds are not presently available for this requirement. Award will be subject to if/when appropriated funds are available The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-50. The associated North American Industry Classification System (NAICS) Code is-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. The Food and Drug Administration (FDA) is soliciting for a bioreactor instrument, with necessary components and consumables permitting immediate use, that can provide a parallel operation for mammalian cell culture with at least (8) vessels. The Division of Product Quality Research within the Center for Drug Evaluation and research (CDER) currently has basic bioreactor capabilities and needs to expand capacity to support the characterization of the Monoclonal Antibody manufacturing process to understand critical variables and utilize Process Analytical Techniques (PAT) and Quality by Design (QbD) techniques. A parallel system is necessary to allow the simultaneous experimentation of multiple variables to perform design of experiments (DOE) and utilize QbD. The quote shall detail the consumables required to immediately operate the instrument to include identification and quantities of the consumables furnished with the instrument and FOB Destination pricing, good for one (1) year from date of award, for additional consumables necessary for continued operation and shall specify the commercial warranty period and nature of support provided during that warranty period. CDER has indicated that the DASGIP BioTools, LLC 8 vessel cellferm-pro system to include the following components will meet their study needs, however, quotes will be accepted and evaluated from all interested parties. - cellferm-pro monitoring system for 8 vessels - cellferm-pro pH and pO2 sensors - cellferm-pro feeding system MP8 - cellferm-pro gas mixing system - DASGIP spinner type DS1000DSS - extra triple port - stainless steel pipe.OD4mm/ID2mm,L320mm - BioReactor support platform - cellferm-pro temperature and agitation system - cellferm-pro heat exchanger - cellferm-pro heating blankets - cellferm-pro additional uninterruptible power supply - DASGIP control-OPC client professional for external autosampler - fedbatch-pro recirculating chiller for 8 vessels The instrument system shall be equivalent to the salient characteristics described herein. • Bioreactor system capable of parallel operation for mammalian cell culture with 8 vessels to study the effects of changes in the manufacturing process on product quality attributes. Each vessel must have independent control of all processing parameters, including: Temperature, Agitation, Dissolved Oxygen control, pH control, Gas Flow/composition control, as well as starting and stopping independent of all other vessels to allow statistical experimentation. The vessels must be non-disposable, i.e. glass with metal headplates and autoclavable (at 121°C) to provide a sterile environment for cell growth. • Size: The Vessel size should be 1L ± 0.2L, with the flexibility to change only the vessels and their assemblies to use on the same system throughout a range of vessel sizes. Capable of changing vessel sizes by purchasing additional vessel assemblies, without having to buy an entirely new control system. • Head plate: Industry standard sizes to assure integration of third party infrastructure- At least 6 threaded and capped 13.5pg (12mm) or 19mm ports (or combination of the two sizes) for Required sensors and piping, with 1 PG13.5 (12mm) Port available for the addition of 3rd party probe (furnished as a plug cap or septum). o Probes to be supplied and monitored: pH, dissolved Oxygen, and temperature. o Adequate Ports and Piping: Sampling, feeding, sparge, and exhaust o Multiports: At least 2 of the dedicated headplate ports will utilize at least 3 input and/our outputs on a single port. The multiports may be used for feeding pumps, sampling, gas addition/exhaust, or other purposes but must not interact with each individual activity of the components in the multiport. o Temperature Control: Automatic temperature control via heating and cooling, can be jacketed vessel, electric heating with cooling fingers, or equivalent. The source must supply an adequate Recirculating chiller (if necessary) to support their system to maintain precise temperature control. • Capable of independent vessel control of heating, cooling, agitation rate, substrate feed rates, and other probes. • Capable of physical and software integration of optional 3rd party probes and accessories (such as FT-NIR, Auto samplers, etc...). • Gas mixing off all 4 supply gasses (Nitrogen, Carbon Dioxide, Oxygen, and Compressed Air) for independent delivery for 8 vessels by mass flow controllers able to compensate for temperature. • At least (16) Peristaltic feeding pumps (2 per vessel) which can be individually adjusted for speed, run in reverse, run in "triggered" feed mode based on shifts in operating conditions, and programmed via algorithmic logic to make real time automated processing adjustments based on internal processing data, as well as external OPC connected real time at-line analytical data (i.e. nutrient analysis, cell count/viability, HPLC analysis, and others). Additionally, the control software needs to account for varying tube sizing for accurate delivery. The pumps must be capable of extremely low flow rates of 0.1mL/Hr, while maintaining accuracy. • Overhead drives must be used to stir the vessel with a pitched blade impeller commonly used for mammalian cell culture. • Individual support structures to prevent the reactors from falling over or sitting directly on the benchtop. • OPC connectivity, licenses, and installation for each of the 8 vessels, capable of monitoring critical processing parameters and creating a control feedback loop with the option of user defined algorithmic logic for automated processing decisions, from external analytical and sampling accessory values with accessibility from remote locations. • Run data exportation: The bioreactor software must be able to export run data to MS excel for end of run data manipulation, appropriate macros or excel add ins for charting and data organization must be provided. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered instrument and components meet the technical requirements identified above. Optional item- basic service agreement to include on-site, travel, labor and parts for repairs, minimum of one preventative maintenance visit per contract option year and software upgrades. Unlimited phone & email support to technical and operational inquiries. Scheduled Items include: 1. The parallel bioreactor system, as specified above is to include bench top assembly, necessary set up and hardware/software connections of the bioreactor system, interfacing with external sampler and other analyzers via hardware with OPC including necessary licenses, peripherals, and support utilities to create a turn key, fully integrated and operational system at the end of the installation/training period. 2. Training for a minimum of two (2) Government operators at the installation site. OPTION LINE ITEMS: (refer to FAR Clause 52.217-7: Option Increased Quantity-Separately Priced Line Item, below). The Offeror shall provide a price quotation for each option line item. 3. Optional Item- Sixteen (16) additional peristaltic pumps. 4. Option year 1-Basic service agreement (after initial 1 year warranty) to include on-site, travel, labor and parts for repairs, minimum of one preventative maintenance visit per contract option year and software upgrades. Phone & email response to service request. 5. Option year 2-Basic service agreement to include on-site, travel, labor and parts for repairs, minimum of one preventative maintenance visit per contract option year and software upgrades. Phone & email response to service request 6. Option year 3-Basic service agreement to include on-site, travel, labor and parts for repairs, minimum of one preventative maintenance visit per contract option year and software upgrades. Phone & email response to service request Note: Warranty and/or service period start/end dates is dependent on delivery/installation and acceptance of the instrument. The estimated date could potentially be as follows: Award of contract- 8/31/11 Instrument delivered/installed/accepted- 90 calendar days ARO 11/29/11. Initial warranty ends on 11/28/12. Service agreement year 1 begins on 11/29/12 Service agreement year 2 begins on 11/29/13. Service agreement year 2 begins on 11/29/14. This time frame is only an example of the potential period of performance. Contract Type: Commercial Item-Firm Fixed Price. Simplified acquisition procedures will be utilized. FOB Point destination. To be delivered/installed 90 calendar days or less after receipt of order (ARO) FOB Point of Delivery for Services and Supplies will be the The US Food and Drug Administration White Oak Campus 10903 New Hampshire Avenue WO Building 62 Loading Dock Silver Spring, MD 20993 Instrument shall be transported for assembly to Building 64 Room 1081. The price shall include delivery to destination. Standard 1-year commercial warranty is required. The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items applies to this solicitation. The following addenda have been attached to this provision: Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm until September 30, 2011. The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows: The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: (i) Technical capability of the items/services offered to include history of successful installation and interfacing with 3rd party autosampler, analytical instruments, and incorporation via OPC; and (iii) Price. In determining best value to the Government, technical capability is more important than price though price remains a significant factor and must be affordable. The proposals will be analyzed to ensure the fulfillment of the minimum technical specifications as specified above. Proposals considered not to meet the minimum specifications may be excluded from further consideration. The specifications described above should be fulfilled, and all information requested should be provided in order to allow for an appropriate determination of best value Technical capability will be determined by review of information submitted by the offeror which must provide a description in sufficient detail to show that the product and service offered meets the Government's requirement. The government is not responsible for locating or securing any information, which is not identified in the proposal however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the product and/or service meets the technical requirements. Offerors shall specifically address the specifications stated above as well as technical specifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the offeror. Offeror shall provide experience with the successful installation and interfacing with 3rd party autosampler, analytical instruments, and incorporation via OPC with the same equipment as specified in this requirement. As technical capability of the instrument becomes essentially equal price may become the ultimate determining factor. Include the firms DUNS number with quote and indicate that ORCA information is current, accurate and complete to this solicitation. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The government reserves the right to make an award without discussions. Because of the unique features and items of each vendor's instrument accessory items may be added to the successful offerors initial proposal. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, applies to this acquisition. The offeror should complete these electronically via ORCA at http://orca.bpn.gov. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (JUNE 2010), applies to this acquisition. The following addenda have been attached to the clause. The following additional provisions and/or clauses apply and incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at https://www.acquisition.gov/far/ 52.212-4 (j). Paragraph (j) of the clause is changed to the following: Risk of loss. Risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon: Delivery of the supplies to the Government at the destination specified in the contract. 52.204-4 Printed or Copied Double-Sided on Recycled Paper.(AUG 2000) 52.204-7 Central Contractor Registration. (APR 2008) 52.222-48 Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Certification. (FEB 2009) 52.217-7 Option for Increased Quantity-Separately Priced Line Item. (MAR 1989) The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within the following: Line Item 3 at time of award or within 365 calendar days after award; Line Item 4 anytime prior to the end of the initial warranty period; Line Item 5 anytime prior to the end of the option year 1 service agreement; Line Item 6 anytime prior to the end of the option year 2 service agreement. Delivery of added items/services shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree. (End of Clause) The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.htm 352.201-70 Paperwork Reduction Act (January 2006) 352.202-1 Definitions (JAN 2006) 352.203-70 Anti-Lobbying (January 2006) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations. (OCT 2009) 352.223-70 Safety and Health (January 2006) 352.224-70 Privacy Act (January 2006) 352.227-70 Publications and Publicity (January 2006) 352.231-71 Pricing of Adjustments (January 2001) 352.242-73 Withholding of Contract Payments (January 2006) The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Contracting Officer's Technical Representative (COTR) specified at award. If the supplies or services are acceptable, the COTR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COTR shall document the nonconforming items/services and immediately notify the contracting officer. The COTR is responsible for: (1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) Interpreting the statement of work and any other technical performance requirements; (3) Performing technical evaluation as required; (4) Performing technical inspections and acceptances required by this contract; and (5) Assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) Direct or negotiate any changes in the statement of work; (2) Modify or extend the period of performance; (3) change the delivery schedule; (4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) Otherwise change any terms and conditions of this contract. The COTR for this order is: To be completed at time of award. An original invoice shall be submitted to the attention of the designated Contract Specialist identified below in accordance with the following instructions. An original and two (2) copies shall be submitted to: Food and Drug Administration Nick Sartain 3900 NCTR Road Building 50, Room 422 Jefferson, AR 72079 Or electrically at nick.sartain@fda.hhs.gov To constitute a proper invoice, the Contractor must submit the invoice on company letterhead and include: (i) Name and address of the contractor; (ii) Invoice date and invoice number; (iii) Contract number; (iv) Description, quantity, unit of measure, unit price and extended price supplies delivered or services performed; (v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading; (vi) Terms of any discount for prompt payment offered; (vii) Name and address of official to whom payment is to be sent (must be the same as that in the Contract or in a proper notice of assignment); (viii) Name, title, and phone number of person to notify in event of defective invoice; (ix) Taxpayer identification number (TIN). (x) Electronic funds transfer (EFT) banking information. (xi) Name and telephone number of the FDA Contracting Officer's Technical Representative referenced on the contract; and (xii) Any other information or documentation required by the Contract. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items (MAR 2011) applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.203-6 alt I, 52.204-10, 52.209-6, 52.219-4, 52.219-8, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-51, 52.223-15, 52.223-16, 52.225-5, 52.225-13, and 52.232-33. One or more of the items under this acquisition is subject to the World Trade Organization Government Procurement Agreement and Free Trade Agreements. CCR Requirement - Company must be registered in the Central Contractor Registration (CCR) system before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit an offer, which if timely received, shall be considered. The offer must reference solicitation number 11-223-SOL-00074. The offers are due in person, by postal mail or email to the point of contact listed below on or before April 20, 2011 by 13:00 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502. For information regarding this solicitation, please contact Nick Sartain at (870) 543-7370, FAX (870) 543-7990 or email nick.sartain@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/11-223-SOL-00074/listing.html)
- Place of Performance
- Address: The US Food and Drug Administration, White Oak Campus, 10903 New Hampshire Avenue, WO Building 62 Loading Dock, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02420938-W 20110410/110408234929-83520a020793fae854e96651c07dd605 (fbodaily.com)
- Source
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FedBizOpps Link to This Notice
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