MASTER AGREEMENTS FOR LARGE-SCALE ISOLATION OF ANTITUMOR AND ANTI-AIDSAGENTS FROM NATURAL SOURCES



NIH GUIDE, Volume 21, Number 15, April 17, 1992



RFP AVAILABLE:  NCI-CM-37814-30



P.T. 34



Keywords:

  Antivirals 

  Chemotherapeutic Agents 

  Natural Products 



National Cancer Institute



The National Cancer Institute (NCI), Division of Cancer Treatment

(DCT), Development Therapeutics Program (DTP), National Institutes of

Health (NIH), is interested in receiving proposals from, and

establishing Master Agreements with, offerors with the capability to:

(1) extract bulk plant, animal, and microbial materials to provide

primary extracts; and/or (2) isolate and purify natural products from

primary extracts of plant, animal, and microbial materials on a pilot

plant scale.  Two separate work areas are available for offerors.

Separate proposals will be required from offerors responding to both

work areas.  The Government will supply the plant, animal, or microbial

material to be processed and details of the known isolation processes.

The successful offerors will supply all equipment, solvents, reagents,

and other materials needed for the project.



WORK AREA NO. 1



Offerors must provide equipment to grind and extract a variety of

natural products in quantities ranging from 50 kg to 10,000 kg of bulk

crude materials.  This includes frozen storage capabilities for up to

1,000 kg of marine materials and equipment for the safe,

non-destructive removal of extraction solvents.  The Government will

supply the plant, animal, or microbial material to be processed.  The

experience and ingenuity of the offerors' process development for pilot

plant extractions and isolations using standard or novel techniques

will be important factors in the evaluation of the proposals.



WORK AREA NO. 2



Offerors must provide equipment for large-scale isolation and

purification of natural products, and have refrigerated storage

capacity for up to 750 gallons of primary extract.  The agents isolated

must be high purity, suitable for subsequent manufacture of clinical

dose forms, and all work must be carried out in compliance with the

Food and Drug Administration Current Good Manufacturing Practices

(FDA-CGMP).  A requirement is that the contractor's facilities must be

in compliance with FDA-CGMP regulations at the time a Master Agreement

Order is awarded under the Master Agreement.  The experience and

ingenuity of the offerors in process development for pilot plant

extractions and isolations using standard or novel techniques will be

important factors in the evaluation of the proposals.



It is anticipated that multiple Master Agreement Awards will be made.

The Request for Proposal (RFP) will be issued on or about April 22,

1992.  Each Master Agreement Award is anticipated for a five-year

period, beginning approximately April 30, 1993.  Address requests for

the RFP to:



Elsa B. Carlton

Contract Specialist

Treatment Contracts Section

National Cancer Institute

Executive Plaza South, Room 604

9000 Rockville Pike

Bethesda, MD  20892

Telephone:  (301) 496-8620



No collect calls will be accepted.



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