NIH GUIDE, Volume 23, Number 8, February 25, 1994


P.T. 34



  Chemical Synthesis 


National Institute of Child Health and Human Development

The Contraceptive Development Branch of the Center for Population

Research, National Institute for Child Health and Human Development

(NICHD), has a requirement for maintenance and operation of a

synthetic peptide facility 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>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) inasmuch 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 percent.

The minimum purity requirements for small quantities (5-100 mg) of

peptides is anticipated to be 93 percent.  The Contractor will

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

including but not limited to HPLC, TLC, optical rotation,

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 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.  No

subcontracting will be permitted.

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 expected to prepare an

Application for Drug Master File (to be submitted to the FDA)

relevant to the peptides synthesized under the contract.  The

Government estimates the effort to be approximately 3.40 technical

staff years annually.  The Principal Investigator should be an

established peptide chemist and should devoted approximately 15

percent effort to the project.  All responsible sources may submit a

proposal which will be considered by the agency.

It is anticipated that one cost-reimbursement incrementally funded

type contract will be awarded as a result of the RFP for a period of

(60) months, beginning November 30, 1994.  The Request for Proposals

(RFP) represents a recompetition of the project "Maintenance and

Operation of a Synthetic Peptide Facility" being performed by the

Salk Institute for Biological Studies, San Diego, California.


This announcement is not an RFP.  RFP NICHD-CD-94-07 will be

available on or about March 1, 1994.  Proposals will be due

approximately 60 days thereafter.  Requests for the RFP must cite the

above RFP number.  Copies of the RFP may be obtained by sending a

written or FAX request to:

Paul J. Duska

Contracts Management Branch

National Institute of Child Health and Human Development

6100 Building, Room 7A07

Bethesda, MD  20892

FAX:  (301) 402-3676


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