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Executive Summary

McDonnell Douglas engineer Charles Walker will be the first pharmaceutical production specialist in space. Walker will be aboard the space shuttle Discovery to activate and maintain the continuous operation of McDonnell Douglas electrophoresis equipment during the scheduled June flight. McDonnell Douglas and J&J are collaborating on the space bioprocessing project. At a March 7-9 seminar in Houston on space bioprocessing, McDonnell's director of electrophoresis operations in space James Rose announced Walker's mission. Rose explained that electrophoresis experiments on earlier space shuttle flights have been so successful that the next step in the development of the project -- operation of the equipment for the duration of flight time -- can now be made. Rose said that the electrophoresis unit which will be used on the June flight will be modified from its original research function to convert it into a continuous production unit. The whole development schedule for the project is now running ahead of initial plans, Rose said. As a result, he noted, J&J will be able to begin testing "space-derived material at least a year earlier" than first anticipated. The accelerated production schedule could allow J&J to begin regulatory filings with FDA much sooner than originally anticipated. "Hopefully, we will satisfy the FDA in a late 1986 time frame, and can actually start a production operation," Rose commented. "We've maintained schedules since 1978 and we plan to be comm McDonnell Douglas' original plans called for further studies in two 1984 space flights on the electrophoresis unit's capabilities. The two firms did not anticipate actual production of the as yet unnamed biological product until July 1985 when a "production prototype" unit is scheduled to go into operation. J&J/McDonnell Douglas had initially planned to supply the material for animal studies with a ground-based electrophoresis unit until then. To become commercially viable, Rose said that the joint project is seeking from NASA a designation that would allow them to participate on any space shuttle flight "within a few weeks notice." He noted: "If NASA could give us six flights a year in that configuration, we could actually make enough material to begin a commercial program." However, Rose asserted that "without some long duration capability, manufacturing in space is not going to mature or become a real economic factor in this country -- going up and down in the shuttle is not an efficient or practical way." He added: "We need long duration capability that can be provided either in unmanned forms of spacecraft or manner forms of spacecraft or manned forms." Rose reported that McDonnell Douglas is currently working in both directions. He noted that the firm is working with Fairchild Corp. on a leased unmanned craft that would operate continuously in space and would be resupplied with unseparated material every four months by space shuttle. McDonnell is also working with Houston-based SII Corp. on a manned pilotable module large enough to carry two production units. Rose noted that the manned module is "an appealing system" since it could be linked to the development of NASA's space station, scheduled for operation in 1992. "If this module is designed properly and in coordination with NASA as a private development, it can be mounted on one of the docking ports that will be provided by the space station," Rose predicted. He also pointed out that while protein production can be done automatically, live cell separation in space will require a "man-habitable situation." Explaining McDonnell Douglas' reason for participating in the program, Rose said, "We perceived in this emerging industry of biotechnology the need for better processes to isolate these materials at the levels of purity required to do meaningful clinicals and ultimate commercial work, as well as produce them at high volume." He added: "Our intent is to expand the applications of our technology to more products to more companies and we will be aggressively discussing this with companies in the future who might have materials where this technology might have a true application." Sponsored by NASA, the American Institute of Aeronautics and Astronautics, and the Texas Medical Center, the seminar was the first of its kind to update both industry and academia on the progress of NASA/industry/university joint bioprocessing efforts. Among the industry attendees at the seminar were representatives from Alpha Therapeutics, Cetus, Ciba-Geigy, DuPont, Lilly, Schering, and Smith Labs. In another seminar presentation, David Scharp, MD, Washington University, reported on last August's space shuttle attempt to separate live pancreatic islet cells using the McDonnell Douglas continuous flow electrophoresis unit. Noting that live cells were tested in space and successfully transported to the university for analysis, Scharp commented: "I am very encouraged and excited about these r

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