National Institutes of Health, National Institute of Allergy and Infectious Diseases, Contract Management Branch, Solar Bldg., Room 3C07, 6003 Executive Blvd. MSC 7610, Bethesda, MD 20892-7610

A -- CHEMISTRY AND PHARMACEUTICAL RESOURCES FOR THERAPEUTICS DEVELOPMENT: DEVELOPMENT AND MANUFACTURE OF DOSAGE FORMS SOL NIH-NIAID-00-11 DUE 030199 POC Ms. Grace Bruce, Contract Specialist, 301-496-0195, Mr. Paul McFarlane, Contracting Officer, 301-496-0349 The Division of AIDS (DAIDS), NIAID supports research to identify therapeutic agents for the prevention and treatment of human immunodeficiency virus (HIV), the opportunistic infections (OIs) associated with acquired immunodeficiency syndrome (AIDS), and M. tuberculosis. Lead compounds are identified through individual research grants. Researchers in these and other DAIDS-sponsored preclinical programs are actively engaged in identifying novel therapeutic approaches to treat diseases caused by these infectious agents. Prior to evaluation in clinical trials most experimental agents require dosage formulation and manufacture in accordance with current Good Manufacturing Practices (GMP). The DAIDS currently utilizes two separate contracts to fulfill its needs for these formulation and manufacturing services. The purpose of this inquiry is to ascertain potential offerors to a planned solicitation to provide these formulation development and manufacturing capabilities. Interested potential offerors should furnish capability information demonstrating past experience and expertise to successfully complete all of the following tasks: 1. Determine necessary physical/chemical properties of drug substances targeted for formulation development, including: identification of pKa's, partition coefficients, solubility in various solvents, pH-solubility profiles, pH-rate profiles, and identification of drug-excipient interactions. 2. Perform all pre-formulation studies necessary to develop dosage forms which are designed to achieve one or more of the following goals: enhanced drug solubility, sustained drug delivery or release, enhanced drug stability, targeted drug delivery, improved bioavailability, acceptability for specialized (e.g. pediatric) use, alternate route of administration. 3. Develop and utilize appropriate analytical methods and techniques to quantitate and assess the stability of drug substances in dosage formulations, and to investigate drug release properties in vitro. 4. Formulate and manufacture pilot batches of conventional pharmaceutical dosage forms (e.g. tablets, capsules, semisolids for topical/mucosal administration, and parenteral formulations) and perform appropriate tests to evaluate the feasibility of utilizing the dosage form in clinical trials. 5. Manufacture, process, package, and label production batches of dosage forms in full compliance with current 21 CFR sections 210 and 211, Good Manufacturing Practice (GMP) regulations. 6. Evaluate bulk drug substances using appropriate analytical assays and conduct quality control testing of dosage forms manufactured in compliance with current Good Manufacturing Practices. Tests will depend on the type of dosage form and may include: drug identity and purity, content uniformity, weight variation, sterility, pyrogenicity, particulate matter, pH, residual moisture, dissolution and disintegration characteristics, ambient and accelerated stability studies. This is not a Request for Proposal (RFP). No RFP is available and the government is notcommitted to award a contract pursuant to this announcement. Interested offerors should furnish three (3) copies of their capability information addressing the items above no later than March 1, 1999, to Ms. Grace Bruce, Contract Specialist, Contract Management Branch, National Institutes of Health, National Institute of Allergy and Infectious Diseases, 6003 Executive Boulevard, Solar Building, Room 3C07, Mail Stop 7610, Bethesda, Maryland 20892-7610. For Overnight Mail use Rockville, Maryland 20852-7610. Posted 02/02/99 (W-SN293645). (0033)

Loren Data Corp. http://www.ld.com (SYN# 0014 19990204\A-0014.SOL)