A -- MAINTENANCE AND OPERATION OF A SYNTHETIC PEPTIDE FACILITY

Notice Date

March 9, 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

N/A!!

Point of Contact

Contact Mr. Robert Stallings, Contract Specialist, 301/496-4611!!

Description

SMALL BUSINESS SOURCES SOUGHT 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 (1-50 grams) of peptides for toxicology 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 greater than 1000, on a small scale and on a large scale as noted above. Specific assignment of peptides and quantities to be prepared will be determined by the Project Officer. Major emphasis will be on the preparation of peptides on a gram-scale (1-50 grams). The Contractor's facilities must meet the requirements for Good Manufacturing Practices (GMP) in as much as GMP must be followed for all peptides prepared for toxicology and clinical studies. The Contractor may be required to supply all gram-scale batches (1-50 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%. The Contractor shall furnish, package, and distribute all peptides synthesized under the contract, as requested by the Project Office, in the amounts designated, together with evidence of purity and characterization including but not limited to HPLC, TLC, quantitative amino acid analysis, mass spectral analysis, NMR, and mixed and parallel chromatograms of the peptide(s) against the standard peptide(s) to be furnished by the Project Officer. A functional group analysis by TLC spray reagent, and evidence of electrophoretic homogeneity may also be required as well as sequence analysis of the peptides. An additional requirement for peptides prepared under GMP will be water, salt, and C, H, & N analysis (including ash content) and an estimation of peptide content. As a minimum requirement, the Contractor's facilities must meet requirements in compliance with OSHA for protection of its workers. The contractor's facilities must be operated in accordance with current Good Manufacturing Practices (GMP) issued by the FDA. Whenever necessary, the Contractor will be espected to prepare an Application for Drug Master File (to be submitted to the FDA) relevant to the peptides synthesized under the contract. The required service is defined as code 325412 under the North American Industry Classification System (NAICS). For the purposes of this synopsis, a small business is defined as one that employs no more than 750 persons. Small businesses that believe they have the ability to satisfy the stated requirement, and meet the above size standards, are encouraged to submit a capability statement within 45-days of the publication of this synopsis. Your capability statement should be limited to twenty-five pages or less and include: 1) a description of relevant experience in the solid phase synthesis, purification, and characterization of specific peptides 2) a description of available equipment and facilities accredited as meeting cGMP standards and possessing a nuclear license and a controlled substance license. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS. If responses indicate the likelihood of satisfactory competition among qualified small businesses, the anticipated solicitation will be restricted to samll businesses only. Interested organizations should submit a letter of interest and capability statement, via e-mail, fax, or mail, within 45 days of the date of this publication, to: Robert Stallings, Contract Specialist Contracts Management Branch, OAM, NICHD 6100 Executive Boulevard, Suite 7A07, MSC 7510 Bethesda, e-mail: nichdcmb@mail.nih.gov

Record

Loren Data Corp. 20010313/ASOL004.HTM (W-068 SN50F7T9)