SOURCES SOUGHT
A -- Insect Cell Based Biopharmaceutical Development - S09-198 - RFI Notice 7-21-09
- Notice Date
- 7/21/2009
- 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
- S09-198
- Archive Date
- 9/30/2009
- Point of Contact
- Howard Souder, Jr., Phone: 301-846-5096
- E-Mail Address
-
souderhr@mail.nih.gov
(souderhr@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- RFI - S09-198 - Insect Cell Based Biopharmaceutical Development General Information: This Request For Information (RFI) 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. Any questions concerning this solicitation must be directed through the SAIC-F point of contact, at the email address listed below. RFI Number: S09-198 Posted Date: 7/21/2008 Response Due Date: 8/31/09 by 3:00 PM - Eastern Daylight Time (EDT) Contracting office address: SAIC-Frederick, Inc. 92 Thomas Johnson Drive, Suite 250 Frederick, MD 21702-1201 Purpose of RFI: SAIC-F is seeking companies or academic institutes with knowledge and experience on laboratory development (using an insect cell based system) from gene sequence of interest for either a therapeutic protein or self assembling virus like particles (VLP).. Requirements o The initial gene construct would be provided; Note: proteins will not be engineered with affinity tags. o Must have capability for confirmatory sequencing and appropriate vector construction. o Generate recombinant baculovirus and perform appropriate molecular characterization. o Must have access to qualified cells and appropriate facilities to prevent cross-contamination and provide suitable scale-up for high-titer virus stock. Responder Instructions: Responders must submit a capability statement (10 page limitation, excluding resumes) describing their organization's experience and abilities to further develop the proposed material as described which includes: (a) the professional qualifications and experience of key staff who may be assigned in the developing/manufacturing of the prototype; (b) listing of any/all current and relevant certifications from a qualified neutral third-party and contact information; (c) provide experience in expression optimization; (d) provide methods and approaches for purification at lab and pilot scale; (e) Provide knowledge and relevant experience for expected purity criteria for clinical-grade vaccines and proteins expressed in insect-cell systems; (e) Provide experience and capabilities for executing cGMP clinical production programs for Phase I/II trials; (f) Provide any relevant experience with FDA or other regulatory agencies; (g) a general description of the facilities and other resources available to develop/manufacture the material; (h) an estimated cost broken down in a Time and Material (T & M) format of defined materials and services; and (i) an estimated production schedule. The initial response should include the following Business Information in addition to the capability statement: 1) RFI Number 2) DUNS number 3) Company Name 4) Company Address 5) Company Point of Contacts, Phone, FAX, and Email Address. POC's should include individual(s) who is(are) duly authorized in managing any/all technical issues and/or questions, and individual(s) who is(are) authorized in managing any/all contractual issues and/or questions. 6) Type of Company (i.e. small business, large business, educational institution, etc.) The final date to submit questions for this RFI is 12 noon on August 14, 2009 The last date to submit final responses to this RFI is 3:00 PM, August 31, 2009 Point of Contact Primary: Mr. Howard Souder, Jr., Subcontract Specialist, Phone (301) 846-5096, Fax (301) 228-4037, Email: souderhr@mail.nih.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/S09-198/listing.html)
- Place of Performance
- Address: TBD, United States
- Record
- SN01882928-W 20090723/090722002241-e5adc0bca0190fdcecb8f621a1d44384 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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