SOLICITATION NOTICE
B -- Custom Camelid Single Domain Antibody Phage Display Library
- Notice Date
- 8/21/2014
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- 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
- FDA-1135133
- Archive Date
- 9/12/2014
- Point of Contact
- Carrie Strachan, Phone: 2404027620
- E-Mail Address
-
carrie.strachan@fda.hhs.gov
(carrie.strachan@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for a custom camelid single domain antibody phage display library. This is for commercial items prepared 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. a. Solicitation Number 1135133 is being issued as a Request for Quotation (RFQ). b. Provisions and clauses are those in effect through Federal Acquisition Circular 2005-76, effective 25 July 2014 c. The associated NAICS Code is 541711 and small business size employees 500. This acquisition is set aside 100% for small business concerns. d. Item Description: The Food and Drug Administration (FDA) is developing reagents to improve assays to test purity and potency of probiotic products. To better identify and quantify individual bacteria in a mixed preparation probiotic product, specialized reagents that can be used to develop simple yet robust potency assays are required. The approach to identify specific reagents is to develop a camelid single domain antibody phage display library against several strains of Bifidobacteria or Lactobacilli that can subsequently be used in subtractive screening experiments for high affinity, species specific, single domain antibodies (also referred to as nanobodies) to target probiotic Bifidobacteria and Lactobacillus organisms. The identified antibodies/nanobodies from the screen will be used to develop them as reagents for improved potency assays that will allow FDA to accurately identify individual species in a mixed-species probiotic mixture. The camelid single domain antibody phage library will be developed from llamas immunized with a mixture of 3 whole cell, irradiated strains of Bifidobacteria and Lactobacilli. Vendors need to have experience performing llama immunizations with whole cell irradiated bacteria, and be able to generate a phage display library from the immune sera with a high level of diversity. The high diversity will ensure better chances of obtaining clones that bind the target antigen (irradiated whole cells) in subsequent panning and screening experiments. Vendors will need to be able to perform subtractive screens against the antigens and identify high affinity, species specific clones expressing antibodies, which will be used to develop reagents for better potency assays. The vendor shall have their own camelid facility and be able to perform immunizations of llamas/camelids using whole cell bacterial cell preparation of Bifidobacteria and Lactobacilli provided by FDA. Vendor shall construct a custom phage display library with a high diversity, which translates to a library with a population size of 3x 10^9 and an insert rate > 95%. Vendors shall be AAALAC and OLAW certified. Vendor shall provide at least one (1) peer reviewed publication that describes previous work related to the development and experience with sdAbs. The vendor shall also provide the following during project development: · Antiserum and PBCM cells post immunization · Interim data, such as ELISA screening to determine appropriate immune response. · Immune response test report o word or PDF document describing the work done, and summarizing results o excel sheet summarizing data from immunizations, with graphs as appropriate · Camelid single domain phage display library of high diversity with a population size of 3x 10^9 and an insert rate > 95%. · Quality control and validation date o word or PDF document describing the work done, and summarizing results o excel sheet summarizing data from immunizations, with graphs as appropriate · At least one positive close from each subtractive panning · Amino acid sequences for positive binders e. Period of Performance The llama immunization and library construction shall take approximately 33 weeks upon receipt of the antigen. f. Deliverables: Antiserum and PBCM cells post immunization Interim data, such as ELISA screening to determine appropriate immune response. Immune response test report o word or PDF document describing the work done, and summarizing results o excel sheet summarizing data from immunizations, with graphs as appropriate Camelid single domain phage display library of high diversity with a population size of 3x 10^9 and an insert rate > 95%. Quality control and validation date o word or PDF document describing the work done, and summarizing results o excel sheet summarizing data from immunizations, with graphs as appropriate At least one positive close from each subtractive panning Amino acid sequences for positive binders g. FAR Provision 52.212-1 (Instructions to Offerors - Commercial Items) (APR 2014) applies to this acquisition. Para (k) requires current registration in SAM at https://www.sam.gov. h. FAR Provision 52.212-2 Evaluation - Commercial Items (JAN 1999) applies to this acquisition. Award will be made to the Lowest Priced Technically Acceptable Offeror whose quote provides sufficient detail to evaluate compliance with the solicitation It is the responsibility of all interested offerors to review this site frequently for any updates/ amendments that may occur during the solicitation process. The posting of this requirement does not obligate the Government to award a contract nor does it obligate the Government to pay for any proposal preparation costs. The Government reserves the right to cancel this procurement/ solicitation either before or after the solicitation closing date, with no obligation to the offeror by the Government. The Government will issue a contract to the responsible, responsive offeror, with acceptable past performance, submitting the lowest price. All prospective contractors must be registered in the System for Award Management in order to be eligible for contract award. For registration, go to www.sam.gov and follow the instructions. i. Quotations must include a completed copy of FAR Provision 52.212-3 (Offeror Representations and Certifications - Commercial Items) (MAY 2014). Electronic submission is located at https://www.sam.gov. j. This order will include the following referenced clauses which may be accessed electronically at http://farsite.hill.af.mil. FAR 52.212-4 (Contract Terms and Conditions-Commercial Items) (MAY 2014) FAR 52.232-40 Providing Accelerated Payment to Small Business Subcontractors (DEC 2013) FAR 52.212-5 (Contract Terms and Conditions Required to Implement Statues Or Executive Orders-Commercial Items) (JULY 2014) FAR 52.219-8 (Utilization of Small Business Concerns and Small Disadvantage Business Concerns) (MAY 2014) FAR 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)) FAR 52.222-3, Convict Labor (June 2003) (E.O. 11755) FAR 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126) FAR 52.222-21, Prohibition of Segregated Facilities (Feb 1999) FAR 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246) FAR 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793) FAR 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513) FAR 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury) FAR 52.232-33 (Payment by Electronic Funds-System for Award Management (JUL 2013) FAR 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a) HHSAR 352.202-1 Definitions (JAN 2006) HHSAR 352.203-70 Anti-lobbying (JAN 2006) HHSAR 352.215-70 Late Proposals and Revisions (JAN 2006) HHSAR 352.233-71 Litigation and Claims (JAN 2006) HHSAR 352.242-73 Withholding of Contract Payments (JAN 2006) FAR 52.212-5 (Contract Terms and Conditions Required to Implement Statues Or Executive Orders-Commercial Items) (JULY 2014) FAR 52.219-8 (Utilization of Small Business Concerns and Small Disadvantage Business Concerns) (MAY 2014) FAR 52.232-33 (Payment by Electronic Funds-System for Award Management (JUL 2013) HHSAR 352.202-1 Definitions (JAN 2006) HHSAR 352.203-70 Anti-lobbying (JAN 2006) HHSAR 352.215-70 Late Proposals and Revisions (JAN 2006) HHSAR 352.233-71 Litigation and Claims (JAN 2006) HHSAR 352.242-73 Withholding of Contract Payments (JAN 2006) k. QUOTATIONS ARE DUE BY 2:00PM Eastern Standard Time on 28 AUGUST 2014 in order to be considered. Send quotation responses to Carrie Strachan @ Carrie.Strachan@fda.hhs.gov. Assistance or questions about this announcement may be sent to the above email.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-1135133/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Ave., Building 52/72 Room 3223/3380, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN03475713-W 20140823/140822000547-baa8889b1042f31651d5f98f16dd4c40 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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