National Cancer Institute-Frederick Cancer Research and Development Center, SAIC Frederick, P.O. Box B, Contracts Department, Frederick, MD 21702-1201; Attn: Donna L. Dawson

A -- NOTICE OF INTENT TO SEEK EXPRESSIONS OF INTEREST IN THE USE OF A LARGE-SCALE BIOPROCESS FACILITY INCLUDING BOTH FERMENTATION AND RECOVERY PLANTS POC Terry Hebb, Contracts Administrator, 301/846-5416, Donna Dawson, Contracting Officer, 301/846-1087. SAIC Frederick, the Operations and Technical Support Contractor to the National Cancer Institute-Frederick Cancer Research and Development Center (NCI-FCRDC) in Frederick, Maryland, seeks expressions of interest in use of the FCRDC Natural Products Pilot Plant (NPPP), a large-scale bioprocess facility. The NPPP is comprised of both fermentation and recovery plants. The fermentation plant has a maximum fermentation capacity of 2,000 gallons per batch (from a 3,000-gallon nominal volume production fermentor) with two 30-gallon and two 300-gallon fermentors for seed development, process development research, or intermediate-scale production. The recovery plant has the capability of performing large-scale solvent extraction, solid/liquid separation from fermentation broths or other feedstocks by several different methods, concentration of products of interest by controlled evaporation of solvent carriers, and provides equipment and facilities suitable for the recovery and isolation of crude, partially purified, and highly purified products derived from fermentation broths, plant materials, and other starting materials. The fermentation plant is designed for operation at a BL2 large-scale level of containment, and the recovery plant at a BL1 large-scale level of containment. The NPPP has been used for fermentation process development, scale-up studies, production of purified natural and biological products from a variety of feedstocks in support of drug development research, and production of bulk cells and cell-derived products. The fermentation plant is primarily designed for the fermentation of bacteria, fungi, and yeasts and is not appropriate for growing mammalian or insect cell cultures. Renovations to the NPPP are nearing completion with availability for use expected in early 1996. Recent upgrades include a state-of-the-art data-acquisition system for monitoring and controlling the 30- and 300-gallon fermentors, a contained continuous decanter centrifuge, a large-scale HPLC system, new stainless steel process vessels, and a new double-pass reverse osmosis process water system. SAIC Frederick provides skilled technical personnel with more than two decades of experience operating the pilot plant in support of drug discovery and development workscopes for NCI and the private sector. SAIC Frederick also provides experienced Quality Assurance, Quality Control and facility support staff for production of bulk chemicals and biologicals in support of pre-pivotal (Phase I and Phase II) clinical trials. All employees are trained in current Good Manufacturing Practices. NPPP facilities will be committed in part to support NCI workscopes concurrent with availability to users outside of NCI. When necessary, accomodations will be made to ensure that NCI work receives the appropriate priority. Additionally, cancer- and AIDS-related work will be given preference in obtaining use of the facility in concert with the overall objectives of NCI-FCRDC. However, other work will not be precluded from consideration. Upon determining the level of interest in use of the facilities by responsible NCI officials, prospective users may be invited to NCI-FCRDC for a site visit at which time additional information and conditions for use will be made available and a tour of the plant arranged. Detailed workscopes or project plans will then be requested and reviewed for a determination of consistency with the mission of the NCI, an assessment of technical feasibility, and development of formal cost estimates. (213)

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