Accession Number : ADA301704

Title :   Services to Operate a Hemoglobin Production Facility and a Red Blood Cell Storage Laboratory.

Descriptive Note : Annual rept. 21 Sep 94-20 Sep 95,

Corporate Author : BIONETICS CORP HAMPTON VA

Personal Author(s) : Lippert, Lloyd E.

PDF Url : ADA301704

Report Date : OCT 1995

Pagination or Media Count : 33

Abstract : A research laboratory to support red blood cell preservation research, a facility to manufacture acellular hemoglobin solution and a quality control laboratory to support the hemoglobin production were established at the Blood Research Detachment, 1413 Research Boulevard, Rockville, MD with equipment from the Letterman Army Institute of Research. Procedures were established, equipment maintained and staff trained to support both in vitro and in vivo evaluation of preservative solutions which will extend the shelf life of liquid stored red blood cells. Likewise, standard operating procedures were established, equipment was maintained, staff were trained, and 180.5 kg of hemoglobin solution containing 16.2 kg of hemoglobin which met or exceeded contract specifications was manufactured in the hemoglobin production facility (HPF). Three lots of material were manufactured for the US Navy lipisome encapsulated hemoglobin program. Ten hemoglobin production process improvements were implemented and a series of process validation studies were initiated. Substantial progress has been achieved in bringing the HPF into closer compliance with current Good Manufacturing Practices, a necessary step of Phase I and II clinical trials. Systems are in place to support the Blood Research Detachment's combat casualty care research mission.

Descriptors :   *IN VIVO ANALYSIS, *HEMOGLOBIN, *BLOOD CELLS, *BLOOD STORAGE, TEST AND EVALUATION, MANUFACTURING, CONTRACTS, PRODUCTION, VALIDATION, TRAINING, SOLUTIONS(MIXTURES), SPECIFICATIONS, FACILITIES, RESEARCH FACILITIES, QUALITY CONTROL, ENCAPSULATION, LABORATORIES, SHELF LIFE.

Subject Categories : Medicine and Medical Research
      Medical Facilities, Equipment and Supplies

Distribution Statement : APPROVED FOR PUBLIC RELEASE