SOLICITATION NOTICE
Q -- Custom Mouse Monoclonal Antibody Production
- Notice Date
- 7/1/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA1059648
- Archive Date
- 7/31/2009
- Point of Contact
- David - Kordel,
- E-Mail Address
-
david.kordel@fda.hhs.gov
(david.kordel@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Subject: Custom Mouse Monoclonal Antibody Production Solicitation Number: FDA1059648 Response Date: 16 July 2009 DESCRIPTION: THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5. This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-33. The associated North American Industrial Classification System (NAICS) code for this procurement is 325414 for a 100% small business set-aside. Statement of Work The goal is to produce monoclonal antibodies (mouse IgG) for food allergen or allergenic food components for the food allergy groups specified by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA): milk, egg, peanut, tree nuts, fish, shellfish, soy, and wheat. Multiple monoclonal antibody productions are required for the project. Either the peptide sequence or protein immunogen (3-4 mg) derived from one of the food allergen groups will be provided by the lead FDA scientist for each production. If the peptide sequence is provided then peptide synthesis, purification and conjugation shall be required by the contractor prior to introduction into animals. The contractor shall give advice in designing peptide sequence to maximize immune response. A number of Balb/c mice shall be immunized by the contractor according to a standard immunization protocol using adjuvant, if necessary. After initial and subsequent immunizations, ELISA evaluations of titer prior to selection for fusion with myeloma cells shall be performed by the contractor. Once the acceptable titer is obtained, hybridoma fusion using splenocytes from mice shall be performed by the contractor. Screening of supernatants from the growing hybridoma wells by ELISA shall be performed by the contractor to select 10 positive clones. These 10 positive clones shall be sent to the requestor and the requestor shall select two of these 10 clones. The two selected clones shall be sub-cloned by limiting dilution and expanded by the contractor. All 10 positive clones shall be stored frozen by the contractor for at least up to a year and supplied to the requestor upon request. The contractor shall isotype and purify mouse monoclonal antibodies produced and supply them to the requestor. The FDA anticipates approximately 9 monoclonal antibody productions. Invoices shall be submitted at the beginning of each phase after consultation with the FDA lead scientist. Representative phases and contractor estimated costs for each phase: Phase I: Immunization and ELISA evaluation - Immunization of up to 5Balb/c mice, titer screening and evaluation - Peptide synthesis - Costs for Phase I: _________________________ Phase II: Hybridoma fusion and screening of specific clones - Hybridoma fusion using splenocytes - Screening of supernatants from the growing hybridoma wells using ELISA - 10 different ELISA positive clones will be sent to the requestor’s lab for evaluation - Costs for Phase II: _________________________ Phase III: Subcloning - The requestor will select 2 of 10 clones - Sub-cloned by limiting dilution by the contractor - Monoclonal antibody is isotyped by the contractor - Cell line to be shipped to the requestor or stored at the contractor’s site - Costs for Phase III: _________________________ Delivery: The successful offeror shall consult with the FDA lead scientist prior to the production. A minimum number of two productions per request will be requested by the FDA. The final products (antibodies and cell lines) are to be delivered within the agreed-upon production time frame on an as-needed-basis. Material Requirements: The FDA lead scientist will provide either peptide sequences or protein immunogens derived from food allergy groups specified by FALCPA. Place of Performance: The antibody production shall take place at the contractor’s facility and/or laboratory. Period of Performance: Base year plus two option years from the date of award. Contractor shall specify production lead times for each antibody. Each production approximately takes 4-5 months depending on the contractor. The contractor shall be able to produce antibodies simultaneously if two or more productions are requested. QUESTIONS DEADLINE: all questions must be received by email (david.kordel@fda.hhs.gov) before 4:30 pm (1630) EST on 8 July 2009. Delivery terms shall be FOB Destination. FOB Destination means the contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order; and pay all charges to the specified point of delivery. Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this contract to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor described to "Meet or Exceed the Specific Requirement," 2) Past experience, performance capability of contractor, and 3) Price. Past experience, performance capability of contractor and price are significantly more important than storage. The Government will evaluate offers for award purposes by adding the base price plus all options to arrive to the total price for the 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 an option line item. Offerors shall include capability and supporting documentation, sales literature or other product literature which CLEARLY DOCUMENTS that the offered product meets or exceeds the specifications stated herein. FAR provisions can be found on the following website: http://www.arnet.gov. The following provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors-Commercial Items; 52.225-2 Buy American Certificate; 52.212-4 Contract Terms and Conditions-Commercial Items; 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items including subparagraphs: 52.216-22, Indefinite Quantity 52.217-6, Option for Increased Quantity 52.222-3, Convict Labor 52.222-19, Child Labor-Cooperation with Authorities and Remedies 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity 52.222-36, Affirmative Action for Workers with Disabilities 52.222-50, Combating Trafficking in Persons 52.225-1, Buy American Act--Supplies 52.225-13, Restrictions on Certain Foreign Purchases 52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration. This is a Combined Synopsis/Solicitation for custom mouse monoclonal antibody production as defined herein. The Government intends to award a Firm Fixed-Price Purchase Order as a result of this Combined Synopsis/Solicitation that will include the terms and conditions that are set forth herein. Additionally, all quotes shall include price (s); FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS code 325414; delivery date (delivery date is of the utmost importance); business size; and payment terms. Delivery shall be to FDA, College Park, MD 20740. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and be received by 4:30 PM (1630) EST on 16 July 2009 to the attention of David Kordel, david.kordel@fda.hhs.gov. Offerors shall ensure the RFQ number is visible in the header of the email. FAX QUOTES SHALL NOT BE ACCEPTED.
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