SOURCES SOUGHT
A -- Operation & Maintenance of a Peptide Synthesis Facility
- Notice Date
- 6/25/2008
- Notice Type
- Sources Sought
- NAICS
- 325411
— Medicinal and Botanical Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- RFP-NIH-NICHD-CPR-08-02
- Archive Date
- 7/25/2008
- Point of Contact
- Lisa L Coleman,, Phone: 301-435-6963, Ross Kelley,, Phone: 301-435-6960
- E-Mail Address
-
lc304t@nih.gov, rk17a@nih.gov
- Small Business Set-Aside
- N/A
- Description
- Operation and Maintenance of a Peptide Synthesis Facility RELEASE DATE: June 25, 2008 SOURCES SOUGHT: National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) This announcement is not a Request for Proposals (RFP) and does not commit the Government to award a contract now or in the future. No solicitation is available at this time. The purpose of this synopsis is to identify organizations with requisite qualifications to provide the services stated herein. Based on capability statements received in response to this Sources Sought Announcement this acquisition may be solicited as a 100% small business set-aside. All small business organizations (SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB) are encouraged to respond to this notice. This requirement is assigned a code of 325411 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 750 employees. The Contraception and Reproduction Health Branch (CRHB)of the National Institute of Child Health and Human Development (NICHD)/NIH, seeks capability statements from interested and qualified potential sources to provide a Synthetic Peptide Facility (SPF) capable of synthesizing gram scale quantities (1-500 grams)of peptides for toxicological studies, primate testing and clinical investigation as well as small quantities (5-100 milligrams) of new peptides for initial biological testing in small animals. Offerors should have expertise in the synthesis of peptides by solid phase techniques, especially those of MW 20,000 having greater than 50-60 residues. Specific assignment of peptides and quantities to be prepared will be determined by the Project Officer. BACKGROUND This service facility has advanced the program objectives of the Branch by providing large quantities of peptides for initial biological testing, preclinical and clinical studies. 143 peptides were synthesized for the past 5 years. It is expected that the Contractor will be able to prepare up to 500 grams of the desired peptides by suitable modifications(s) of previously employed smaller scale procedures. (A standard sample of the requested peptides will often be supplied by the project officer. It is anticipated that not more than two 500-gram batches of peptide will be required to be synthesized in a single contract year. TECHNICAL REQUIREMENTS The service facility shall be located in facilities owned or operated by the contractor with specific space allocated for purpose of this contract. Organizations that submit capability statements in response to this notice will be evaluated against the following technical areas of experience and expertise: A. Experience and Expertise. Provide a description and documented evidence of the experience and expertise of the staff. Specifically, the Principal Investigator must have demonstrated experience as a peptide chemist. Provide names of projects and references, noting those in support of submission of data to FDA for new drugs, distinguishing previous experience from current projects. Response must include number of samples as well as duration and description of services provided, in sufficient detail to demonstrate: i. Experience in preparing and training appropriate staff on policies, procedures, and guidelines required for all necessary activities that involve the furnishing, packaging, and distribution of peptides that have been synthesized, together with evidence of purity and characterization. ii. Experience in long-acting formulations with sustained release of peptides for a period of a minimum of three months. iii. Experience in handling and archiving chemical samples iv. Personnel with demonstrated ability and experience to manage a synthesizing gram scale quantities of peptides for toxicological studies, primate testing and clinical investigation as well as small quantities of new peptides for initial biological testing in small animals. v. Personnel with demonstrated ability to accurately and safely receive, inventory, process, store, retrieve and aliquot samples, and to conduct processing services. vi. Ability to package and ship periodically up peptides both domestically and internationally during the contract to designated laboratories according to international, federal, state and local regulations. vii. Ability to ship under appropriate conditions, in appropriate containers, to the proscribed destination; b. Maintain adequate records on all shipments; c. verify arrival of all samples at destination. B. Facilities: Provide a brief description of the facilities and demonstrate the capability to meet requirements in compliance with OSHA for protection of laboratory workers. The capability statement must demonstrate that the Contractor’s facilities must be operated in accordance with current Good Manufacturing Practices (cGMP). Interested organizations that believe they possess the capabilities necessary to undertake this project should submit electronic copies in addition to four (4) hard copies of their capability statement, addressing the areas above. Please limit responses to fifteen (15) pages or less. Any proprietary information should be so marked. Written capability statements should be received by the Contracting Officer by no later than 4:00PM local time on July 10, 2008. Capability statements must identify the business status of the organization (i.e. educational institution, non-profit, large business, small business, 8 (a), or other corporate or non-corporate entity). NO COLLECT CALLS WILL BE ACCEPTED. RESPONDENTS MAY SUBMIT THEIR CAPABILITY STATEMENTS VIA E-MAIL IN ADDITION TO THE 4 HARD COPIES. Responses should be no more than 15 pages. These pages exclude resumes. INQUIRIES Lisa K. Coleman Contracting Officer National Institute of Child Health and Human Development NIDDK OA, National Institutes of Health 6100 Executive Boulevard, Suite 7A07, MSC 7510 Bethesda MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: 301-435-6963 Fax: 301-402-3676 E-mail: lc304t@nih.gov OR Ross Kelley Contracting Officer National Institute of Child Health and Human Development NIDDK OA, National Institutes of Health 6100 Executive Boulevard, Suite 7A07, MSC 7510 Bethesda MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: 301-435-6960 Fax: 301-402-3676 E-mail: rk17a@nih.gov
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