Operation and Maintenance of a Peptide Synthesis Facility

Notice Number: NOT-HD-09-001

Key Dates
Release Date: September 22, 2008

Issued by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)

Pre-Solicitation Notice: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov/)

The National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) anticipates awarding a contract(s) to an organization or organizations 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.  The anticipated contract type will be a cost reimbursement, completion type contract with a five to seven year period of performance.  Further details will be provided in the Request for Proposals (RFP) to be issued approximately 2 to 4 weeks after the publication of this announcement. This announcement is intended to inform interested offerors of a planned RFP, of important background information, and of some key requirements essential for responding to the RFP

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 interested that submit proposals in response to the RFP will be evaluated against the following technical areas of experience and expertise: 

A.     Experience and Expertise.  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:  Detailed description of the facilities and demonstrate the capability to meet requirements in compliance with OSHA for protection of laboratory workers.  The Offeror must demonstrate that the Contractor’s facilities must be operated in accordance with current Good Manufacturing Practices (cGMP).  

The RFP is anticipated to be posted on FedBizOpps (FBO) website: http://www.fedbizopps.gov, through the NICHD website: http://www.nichd.nih.gov/funding/grantcontract/,  and the NIH Guide for Grants and Contracts website: http://grants1.nih.gov/grants/guide/index.html approximately 2 to 4 weeks after the date of the publication of this announcement.

The due date for submission of proposals in response to the RFP is anticipated to be on or about November 15, 2008. Information in the anticipated RFP supersedes any information in this pre-solicitation announcement. This acquisition has been designated as total small-business set aside under the North American Industry Classification System (NAICS) code 325411. 

The reference number to be used for this announcement is: NIH-NICHD-OPPB-09-04. This is not an RFP and this announcement does not commit the Government to award a contract. All correspondence must cite the reference number as provided.

Inquiries

All correspondence must cite the reference number as provided above. No collect calls will be accepted. Any questions concerning this announcement must be submitted in writing to:

Lisa Coleman
Contracting Officer
NICHD Contracts Management Branch
Office of Acquisitions, NIDDK, NIH
6100 Executive Boulevard
Room 7A-07, MSC 7510
Bethesda, Maryland 20892-7510
Email: lc304t@nih.gov  

If hand-delivered or sending by delivery service:
6100 Executive Boulevard
Suite 7A-07
Rockville, Maryland 20852


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