SOURCES SOUGHT
A -- Humanization of Monoclonal Antibodies
- Notice Date
- 6/7/2006
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427, Room 12, Frederick, MD, 21702
- ZIP Code
- 21702
- Solicitation Number
- S06-267
- Response Due
- 6/28/2006
- Archive Date
- 7/13/2006
- Description
- This announcement constitutes a Sources Sought Synopsis. Responses to this publication are solicited to identify qualified sources. Contractors expressing an interest should provide appropriate capability statements. Capability statements should include a description of the organization?s experience and past performance as it relates to the work described herein. CV?s for key personnel should be included in the capability statement. Interested contractors shall also provide (1) an outline of specific work previously performed or being performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement (3) any other specific and pertinent information as pertains to this Sources Sought Notice that would enhance our consideration and evaluation of the information submitted. Responses must reference Request for Information (RFI) number S06-267 and include the following: (1) name and address of firm, (2) type of business (i.e.: small business, small disadvantaged 8(a) certified, woman-owned small business, small disadvantaged business (not 8(a) certified), verteran-owned small business, etc.) (3) two points of contact: name, title, phone, fax and e-mail, (4) DUNS number, (5) contractor?s capabilities statement: relevant work including a summary of work performed, contract number, contract type, dollar value for each customer, reference and customer point of contact with phone number. Responses shall be submitted via e-mail to: Melayne A.C. Richards at mrichards@ncifcrf.gov not later than 4PM (EDT) Wednesday June 28, 2006. Statement of Work The Biopharmaceutical Development Program (BDP) located at the National Cancer Institute at Frederick, Maryland is attempting to identify qualified vendors with experience in humanization of monoclonal antibodies. The overall goal of this work is for the vendor to receive a murine hybridoma that expresses a mAb and provide at least two cell lines that express a ?humanized? or ?fully human? version of the antibody with similar epitope binding characteristics. This antibody will ultimately be used in pre-clinical and clinical studies. The proposal may be either fixed price or cost reimbursable and may be performed under non-GLP, GLP, or cGMP compliant conditions. The use of non-BSE components throughout the process is preferred. The deliverables include: 1. Sequencing and/or cloning of the appropriate murine heavy and light chain sequences from the hybridoma provided by the BDP. 2. Cloning of humanized vectors and release of confirmatory DNA sequence information to the BDP. 3. Generate at least 2 stable cell lines that produce the humanized antibody. The antibody must maintain epitope binding characteristics that are similar to the parental mAb. Expression levels should be adequate for multi-gram productions. 4. Provide a reference lot (~ 1 L) of supernatant from each cell line to the BDP for use strictly in a small scale mAb purification process followed by limited characterization to assess the quality of the expressed mAb. 5. Upon approval, transfer of the appropriate cell line or lines to the BDP. The cell line(s) may be provided in an accession bank or cGMP compliant master cell bank format. 6. All GMP work will be performed under the SAIC Frederick, Inc. Quality Agreement or a mutually agreed upon Quality Agreement. THIS SYNOPSIS IS FOR INFORMATION AND PLANNING PURPOSES AND IS NOT TO BE CONSTRUED AS A COMMITMENT BY SAIC-FREDERICK, INC. OR THE GOVERNMENT. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT AND ANY FOLLOW-UP INFORMATION REQUESTS. ALL INFORMATION SUBMITTED IN RESPONSE TO THIS ANNOUNCEMENT MUST ARRIVE ON OR BEFORE THE CLOSING DATE. THE CLOSING DATE FOR RESPONSES IS 4PM (EDT) Wednesday June 28, 2006. Point of Contact: Melayne A. C. Richards Contracts Specialist SAIC-Frederick, Inc. e-mail: mrichards@ncifcrf.gov
- Place of Performance
- Address: Subcontractor?s facility
- Record
- SN01063976-W 20060609/060607220854 (fbodaily.com)
- Source
-
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