National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Bldg., Suite 7A07, 6100- Executive Blvd MSC 7510, Bethesda, MD 20892-7510

A -- RADIOLABELING OF BIOCHEMICAL COMPOUNDS & POLYCLONAL ANTIBODY PRODUCTION SOL NICHD-DIR-99-02 DUE 061099 POC Charles Newman, Contract Specilaist, 301-496-4611 E-MAIL: Click here to contact the NICHD Contract Specilaist, cn43m@nih.gov. The National Institute of Child Health Human Development (NICHD) is looking for Capability Statements from potential contractual sources to perform R&D support services for our Division of Intramural Research (DIR), including: A. RADIOLABELING OF BIOCHEMICAL COMPOUNDS and B. POLYCLONAL ANTIBODY PRODUCTION. These services are currently provided by Covance Laboratories, Inc., and administered by the NICHD under contract numbers NO1-HD-5-3222 and NO1-HD-5-3235 that are due to expire on November 30, 1999 and July 13, 2000, respectively. The information requested in the Capability Statements will be evaluated by the NICHD Contract and Program Staff to assist in procurement planning and to develop a source list of capable contractor's that will receive a formal Request for Proposal(s), assuming the NICHD decides to continue procurement of these services. Potential contractual sources capable of performing these services are encouraged to submit Capability Statements at this time. The following is a more detailed description of the capabilities sought by the NICHD. A. The RADIOLABELING of purified proteins, peptides, hormones, cyclic nucleotides, and other materials. 1. Potential contractual sources should provide documentation of their capability to provide for the radioiodination of material employing the following general procedures: a. Iodine monochloride (ref. Methods in Enzymology, 92, 277); b. Oxidizing techniques based on chloro compounds (ref. Methods in Enzymology, 70, 210) Sodium hypochlorite, chloramine-T, iodo-gen; c. Iodination using a peroxidase (ref. Methods in Enzymology, 70, 214); Lactoperoxidase (lactoperoxidase-glucose oxidase, liquid and solid phase), horseradish peroxidase, myeloperoxidase; d. Labeling by conjugation of aromatic structures (ref. Methods in Enzymology, 73, 112) Technique of Bolton and Hunter, iodinated hydroxyphenylpropionyl carbohydrazide, methyl p-hydroxybenzimidate; e. Iodinated tracers for hapten-specific radioimmunoassays (ref. Methods in Enzymology, 73, 79). 2. Potential contractual sources should provide documentation of their capability to perform the appropriate separation and purification of bound and unbound forms of the radio labeled compounds using the following standard procedures: a. Dialysis; b. Ion-exchange chromatography; c. Gel permeation chromatography; d. Lectin affinity chromatography; e. Specific affinity chromatography; f. Receptor specific chromatography, i.e., binding to membranes possessing receptors and subsequent elution (acid, salt, etc.); g. High performance liquid chromatography (HPLC) (ref. Methods in Enzymology, 92, 292); h. Polyacrylamide gel electrophoresis (ref. Methods in Enzymology, 92, 309). 3. Potential contractual sources should provide documentation of their capability to perform routine radioiodination of the following compounds (not necessarily inclusive): a. Growth harmone (GH); b. Chorionic gonadotropin (GC); c. Luteinizing hormone (LH); d. Follicle-stimulating hormone (FSH); e. Thyroid-stimulating hormone (TSH); f. Adrenocorticotrophic hormone (ACTH); g. Prolactin; h. Beta-endorphin; i. Somatostatin; j. Insulin; k. Insulin-like growth factors I & II (IGF I & II); l. Epidermal growth factor (EGF); m. Other growth factors (e.g., transforming growth factors, fibroblast growth factor, nerve growth factor); n. Corticotropin releasing factor (CRF); o. CRF analogs (e.g., [Tyr]CRF, [Tyr32, Nle21]CRF); p. Gonadotropin releasing hormone (GnRH); q. GnRF analogs; r. LH receptors; s. Angiotensin I, II, III (AI, AII, AIII); t. Angiotensin analogs (e.g., [Sar1]AII, [Sar1, Ile8]AII, Sar1, Ala8]AII); u. Lysinopril (angiotensin converting enzyme inhibitor); v. Cyclic guanosine monophosphate (cGMP); w. Cyclic adenosine monophosphate (cAMP); x. Melatonin; y. 6-Sulfatoxy melatonin; z. Steroids (e.g., estradiol, progesterone, aldosterone derivatives, etc.); aa. Investigator provided purified proteins and synthetic peptides. 4. Potential contractual sources should provide documentation of their capability to evaluate each radioactive product interms of purity, specific radioactivity, specific binding activity (self displacement in radioreceptor or radioimmunoassay), and also maximum bindability with excess antibody or receptors; this information shall accompany delivery of the radioactive material to individual NICHD investigators within three days of the placement of an order. B. The production of POLYCLONAL ANTIBODIES generated against these materials and a large and varied number of other antigenic substances. 1. Potential contractual sources should provide documentation that they maintain an animal holding facility within a reasonable distance from the NIH campus, capable of handling mice, rats, rabbits, and guinea pigs with the animals housed in such a way as to minimize microbial and chemical contamination from other animals in the facility. All animals will be provided by the Contractor and those animals arriving at the facility will be held in a quarantine area for a period designated by the Project Officer before they are transferred to a holding room. Animals entering the facility will be positively identified by a numbering system such as ear tags or tattoos, and a record shall be maintained indicating number, strain, sex, date of birth, and date of entry. Potential contractor's shall provide evidence of adequate refrigerator and freezer storage space, with alarm system, for sera from animals and for samples to be used for immunization. 2. Potential contractual sources should provide documentation that they maintain animals according to the standards outlined in the Guide for the Care and Use of Laboratory Animals, The Animal Welfare Act, and the Public Health Service Policy on Humane Care and Use of Laboratory Animals. The potential contractor should provide documentation that they have an Assurance on file with the Office for Protection from Research Risks (OPRR), they are registered with the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA), and they have an Institutional Animal Care and Use Committee (IACUC) to oversee the animal program, facilities, and procedures. 3. Potential contractual sources should provide documentation that they can perform standard immunization using investigator-supplied materials and bleeds (sampling, processing, and packaging) of rabbits, rats, mice, guinea pigs, and any other species. 4. Potential contractual sources should provide documentation that they have the ability to carry out polyclonal antibody production. 5. Potential contractual sources should provide documentation that they have the ability inoculate cells, emulsions, conjugates, or any antigenic material such as polyacrylamide, other gel material, or nitrocellulose. The potential contractual sources shall demonstrate they have the ability to conjugate investigator-supplied antigens with standard antigenicity-enhancers, e.g., keyhole limpet hemocyanin (KLH). The route of injection can be IM, IV, IP, SC, ID, lymph node, or as specified in the protocol. General reference: Laboratory Manual for Basic Biomethodology of Laboratory animals, Vol. I. Mice, Rats, Guinea Pigs, and Rabbits, R. Hitzelberg, E. Lundgren, J. Phillips, MTM Assoc., Inc. 1985. The potential contractor shall provide documentation that they have adequate facilities for the storage of reagents prior to preparation and inoculation and can prepare Inocula per protocol. Immunogens may be emulsified with adjuvants such as complete Freunds adjuvant, incomplete Freund's adjuvant, or synthetic adjuvants. Bordatella pertussis may be used to enhance the immune response. Capability Statements must be submitted, by the due date provided, to Mr. Charles Newman, Contracting Specialist, at the above address. There is no required Standard Form or prescribed format for the Capability Statement. However, in addition to the information requested above, your Capability Statement should include details specifying how the work would be performed, details on experience with similar projects and information on whether your organization is a small business concern. While at this time the NICHD is not asking for proposed prices for performing this work, information on pricing methodologies and information on whether your organization routinely provides these services to private commercial (non-government) sources is encouraged. Please note, there is NO Request for Proposal(s) or formal solicitation associated with this synopsis and the government reserves the right to cancel all requirements at any time. Posted 04/22/99 (W-SN323499). (0112)

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