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COMMERCE BUSINESS DAILY ISSUE OF AUGUST 22, 2001 PSA #2920
SOLICITATIONS

A -- MAINTENANCE AND OPERATION OF A SYNTHETIC PEPTIDE FACILITY

Notice Date
August 20, 2001
Contracting Office
National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Bldg., Suite 7A07, 6100- Executive Blvd MSC 7510, Bethesda, MD 20892-7510
ZIP Code
20892-7510
Solicitation Number
RFP-NICHD-2001-08
Response Due
October 22, 2001
Point of Contact
Robert Stallings, Contract Specialist (301) 496-4611
E-Mail Address
Click here to contact the Contracting Officer via (bs79d@nih.gov)
Description
Description MAINTENANCE AND OPERATION OF A SYNTHETIC PEPTIDE FACILITY The Contraception and Reproductive Health Branch (CRHB) of the National Institute of Child Health and Human Development (NICHD) is recompeting its contract for 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. It is expected that the Contractor will be able to prepare up to 500 grams of the desired peptides by suitable modification(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. The Contractor may synthesize the peptides batchwise or in one large batch, but the final purification may have to be performed by combining all batches and purifying them as a single batch. The Guidelines for current Good Manufacturing Practices must be followed (when so designated) for all peptides prepared for toxicology and clinical studies. Lyophilization of peptides is required for vialing. Long-acting formulation(s) which will provide a sustained release of GnRH antagonist for a period of a month or longer will be required when clinical trials of such peptides are planned. The Contractor will be allowed to use a capable sub-contractor for such work. Sufficient prototype quantities of long-acting formulation(s) shall be submitted to the Government biological testing facility for evaluation of their duration of action. It is also expected that the Contractor will have the expertise to synthesize small quantities of novel peptides for which completely worked-out laboratory procedures may not be available. The purity range requirement for anticipated larger-scale production of peptides is 95% to 97%. To some degree, these requirements will be governed by FDA guidelines in effect at that time. Nevertheless, the Contractor may be required to supply all gram-scale batches (1-500 grams) of peptides at a minimum purity of 97%. The minimum purity requirements for small quantities (5-100 mg) of peptides is anticipated to be 93% to 95%. The purity will be judged using high performance liquid chromatography (HPLC), thin layer chromatography (TLC) and capillary zone electrophoresis (CZE). The contractor shall furnish, package, and distribute all peptides synthesized under the contract, as requested by the Project Officer, in the amounts designated, together with evidence of purity and characterization. They will be evaluated against standard peptides furnished by the NICHD project officer. As a minimum requirement, the Contractor's facilities must meet requirements in compliance with OSHA for protection of laboratory workers. The Contractor's facilities must be operated in accordance with current Good Manufacturing Practices (cGMP) issued by the FDA (see 21CFE, Parts 201, 207, 210, 211 and 229). Whenever necessary, at the written request of the Government, the Contractor will be expected to prepare an Application for Drug Master File (to be submitted to the FDA) relevant to the peptides synthesized under the contract. Government estimates the effort to be approximately 3.40 technical staff years annually. The Principal Investigator should be an established peptide chemist and should devote approximately 15% effort to the project. All responsible sources may submit a proposal. It is anticipated that one cost-reimbursement option type contract will be awarded as a result of the RFP for a period of sixty (60) months, beginning with the effective date of the resultant contract. The RFP represents a recompetition of a project currently being performed by Multiple Peptide Systems of San Diego, California. This announcement is not a request for proposals (RFP). The required service is defined as code 325412 under the North American Industry Classification System (NAICS). The RFP will be issued on or about August 20, 2001 and will be available on the NICHD web page (http://www.nichd.nih.gov/oam_cmb). Proposals are due by 4:00 p.m. EST October 22, 2001. All responsible sources may submit a proposal for consideration. This advertisement does not commit the Government to award a contract. Proposals should be submitted to the following: Robert Stallings, Contract Specialist Contracts Management Branch, OAM, NICHD 6100 Executive Boulevard, Suite 7A07, MSC 7510 Bethesda, MD 20892-7510 Telephone: 301-496-4611 FAX: 301-402-3676 E-mail: bs79d@nih.gov
Web Link
Click here to download a copy of the RFP. (http://www.nichd.nih.gov/funding/funding-opps_rfp.htm)
Record
Loren Data Corp. 20010822/ASOL012.HTM (W-232 SN50V4R4)

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