SOURCES SOUGHT
A -- CpG Sources Sought
- Notice Date
- 9/18/2008
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427, Room 12, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- S09-030
- Archive Date
- 10/18/2008
- Point of Contact
- Howard Souder,, Phone: 301-846-5096, Gene D Anderson,, Phone: 301-228-4008
- E-Mail Address
-
souderhr@mail.nih.gov, eanderson@ncifcrf.gov
- Small Business Set-Aside
- N/A
- Description
- General Information: This Sources Sought Notice (SS) is for INFORMATIONAL AND PLANNING PURPOSES ONLY and SHALL NOT BE construed as a SOLICITATION OR as an OBLIGATION on the part of SAIC-Frederick, Inc. (SAIC-F). THIS IS STRICTLY MARKET RESEARCH. NEITHER SAIC-F NOR NCIF WILL NOT ENTERTAIN QUESTIONS REGARDING THIS MARKET RESEARCH. SAIC-F on behalf of the National Cancer Institute at Frederick (NCI-F) is to seeking to identify a qualified contract manufacturing organization or qualified supplier that can produce or supply the immunological adjuvant CpG. A contract manufacturing organization or supplier that can produce or supply the immunological adjuvant CpG. The product to be supplied must be a Class B phosphorothioate oligodeoxynucleotide 24-mer. The scale of supply must be a single lot or batch of 1 to 10 g. The supplier must be able to produce the material in bulk powder form. It is also desired that the supplier have the ability to further manufacture and formulate the bulk into lyophilized (freeze-dried) final vials. The purity specification will be >92% pure double-stranded monomer as measured by IEX-HPLC (ion exchange high performance liquid chromatography). The material may be provided initially non-GMP but preference will be given to suppliers that can provide bulk and final form under cGMP for clinical trial studies. The supplier must be willing to provide (upon execution of any agreement) documentation supporting the manufacturing and testing of the material and be willing to undergo an independent site visit (for non-GMP) or QA audit (for GMP) of their facilities and operations. Responder Instructions: Responders must submit a capability statement (8 page limitation, excluding resumes) describing their organization's experience and abilities to provide the material as described which includes: (1) a summary of list of buyers (commercial as well as government entities); (2) the professional qualifications and experience of key staff who may be assigned in the manufacturing of the material; (3) listing of any/all current and relevant certifications from a neutral third-party which promote current Good Manufacturing Practices (cGMP) and contact information; (4) a general description of the facilities and other resources needed to manufacture the material; (5) demonstrated ability to produce the material; and (6) approximate cost of defined material. Each response should include the following Business Information in addition to capability statement: 1) Sources Sought Number 2) DUNS number 3) Company Name 4) Company Address 5) Company Point of Contact, Phone, FAX, and Email Address 6) Type of Company (i.e. small business, 8(a), woman-owned, veteran-owned, etc.) as validated by the Central Contractor Registration (CCR). All responders must register on the CCR, located at http://www.ccr.gov/index.asp
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=b0c1fadfe15c942f8d16596ba2b75cf8&tab=core&_cview=1)
- Place of Performance
- Address: To be determined, 0000, 000, United States
- Record
- SN01675497-W 20080920/080918224204-b0c1fadfe15c942f8d16596ba2b75cf8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |