SOURCES SOUGHT
66 -- Production of 50 German Cockroach specific scFvs
- Notice Date
- 8/13/2007
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument 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, MD, 20857-0001, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- FDA-SOL-07-00384
- Response Due
- 8/17/2007
- Archive Date
- 9/1/2007
- Description
- The United States Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) intends to award a sole-source award to MilleGen-Prologue Biotech for the screening of a phage display library of chicken scFv and production of 50 positive clones as soluble scFv. CBER is seeking sources capable of producing 50 German cockroach specific scFvs. This work will be done as part of the development of the multiplex allergen extract potency assay (MAPA). The purpose of MAPA is to assess the overall potency of complex allergen mixtures. CBER is currently in the process of developing and optimizing MAPA for less complex allergen mixtures and are ready to move into more complex mixtures such as the cockroach allergen extract. The development of this assay will be an important step towards analyzing the allergenicity of cockroach extract as well as many other extracts currently on the market that do not have a standard of potency. The source(s) must be able to 1) Develop Phage Display Screening Conditions, 2) Perform 5 cycles of phage display panning and characterize selected binders by: a) ELISA analysis of 576 scFv clones and b) Sequencing of the 120 best scFvs, 3) Produce 0.1-0.3 mg scFv, and 4) Characterize binding profile of 50 scFv clones by ELISA. Interested parties must be able to provide verifiable proof by submitting a) a brief statement of interest, b) company name and point of contact and phone number, c) web-site and email address, and d) a brief description of how they meet each of the requirements listed above. Please do not exceed five pages. This request for information is not a request for competitive proposals. Copies of proposals sent will NOT be honored or acknowledged. Please send questions and information electronically to London.Johnson@fda.hhs.gov. If FDA is unable to identify any sources capable of providing the screening of a phage display library of chicken scFv and production of 50 positive clones as soluble scFv, an award will be made to MilleGen-Prologue Biotech.
- Record
- SN01370515-W 20070815/070813220401 (fbodaily.com)
- Source
-
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