SOLICITATION NOTICE
A -- Maintenance and Operation of a Peptide Synthesis Facility
- Notice Date
- 1/29/2008
- Notice Type
- Solicitation Notice
- NAICS
- 541711
— Research and Development in Biotechnology
- 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, MD, 20892-7510, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-NIH-CRP-CRHB-SS-001
- Response Due
- 3/15/2008
- Archive Date
- 3/30/2008
- Point of Contact
- Ross Kelley, Contracting Officer, Phone 301-435-6960, Fax 301-402-3676, - Lisa Coleman, Contract Specialist, Phone 301-402-8552, Fax 301-402-3676
- E-Mail Address
-
rk17a@nih.gov, lc304t@nih.gov
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Institute Diabetes and Digestive and Kidney Diseases, Office of Acquisitions, The National Institute of Child Health and Human Development (NICHD) Branch, intends to negotiate a 5 month extension to the contract with NeoMPS Inc. to continue operations of Peptide facility. The extension is required because of delays in a planned FY2007 acquisition for this requirement. The planned extension will permit the repository to continue to function and provide compounds for on going clinical trials while a new acquisition is conducted for these services. The proposed extension will prevent a lapse in service until a new contract can be awarded. NeoMPS has been operating the Peptide facility under Contract N01-HD-23339 since 2002. The requirements of the contract are: 1.Synthesize, purify and characterize specific peptides requested by the Work Assignment Order in the amounts designated and furnish them to the Contraception and Reproductive Health Branch or distribute them as requested by the Project Officer. The peptides may be synthesized batch wise or in one large batch, but the final purification shall be performed by combining all batches and purifying them as a single batch. Guidelines for current Good Manufacturing Practices must be followed when specifically requested by the Project Officer for all peptides designated for toxicology and/or clinical studies. Provide evidence of purity and characterization (as detailed below in item #6) for all peptides submitted. Ordinarily, the minimum purity of submitted must be 95 %; however, a minimum purity of 97% may be required. The final decision with regard to purity specifications and acceptability will be made by the Project Officer. All work shall be performed in compliance with OSHA regulations and guidelines for protection of the employees. 2. Provide a long-acting formulation(s) with sustained release of peptides for a period of three month or longer, utilizing a subcontractor when necessary as requested by the Project Officer. Prior to submission, it is advised that sufficient quantities of prototype of long-acting peptide formulation(s) should be submitted to the branch=s biological testing facility for evaluation of duration of action. 3. Submit a ACompound Submission Form (NIH-1966)@ (See Attachment VII), describing physical and chemical properties, for each peptide, particularly reverse phase HPLC including blown out (off-scale) version, capillary zone electrophoresis (cze) analysis and LC/MS Ion spray. 4. Undertake HPLC analysis of peptide stability testing at 5?, 25? and 40? C and pyrogen-free testing when requested by the Project Officer (See USP XXII National Formulary XVII ? 211. 166 Stability testing (a), (b), and c and; ? 211.167 Special Testing requirements for sterility and pyrogen-free testing, page 1679 (1990))5.Furnish, package and distribute all peptides synthesized and lyophilized 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 LC-MS, HPLC, TLC, CZE, optical rotation, qualitative amino acid analysis, mass spectral analysis, NMR and mixed and parallel chromatogram of the peptide(s) against the standard peptide(s) to be furnished by the Project Officer. A functional group analysis by TLC spray reagent, evidence of electrophoretic homogeneity may also be required as well as sequence analysis of the peptides. An additional requirement for peptides prepared under cGMP guidelines will be water, salt and C, H & N analysis (including ash content) and an estimate of peptide content.
- Record
- SN01494737-W 20080131/080129223432 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |