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Intellectual Property
ISSUED AND APPLIED FOR PATENTS ON THE BEVS PROCESS AND PROPRIETARY PRODUCTS
- Serum-free, stable, scalable, high yielding high-density cell line (US Pat. No. 6,103,526 issued in 2000)
PSC issued patent covers its expresSF+®, an exceptionally high yielding insect cell line that produces proteins at large scale without the use of media containing fetal bovine serum. expresSF+® cells grow rapidly to high densities and are exceptionally robust and stable at higher larger volumes-critical factors in making recombinant proteins at commercial scale. The patent also covers all cell lines derived from the original SF9 cells that grow in serum-free conditions and are stable for at least six months - basically all cell lines that can be used to produce clinical materials. The expresSF+® cells have been tested in accordance with FDA protocols and used for production of materials for therapeutics, vaccines and diagnostics used in human clinical trials.
- Secretion technology (US Pat. No. 5,976,552 issued in 1999)
PSC's issued patent covers a cloning technology that causes many proteins to be secreted into the media (as opposed to being retained in the cell membrane). Secretion of proteins makes it possible to maintain high yields during production without denaturation and loss of biological activity and simplifies recovery of products, thereby increasing yields and reducing production cost.
- High-density fermentation (patent pending - significant claims allowed in initial USPTO review)
PSC believes its high-density manufacturing technology will significantly increase yields of many recombinant proteins made in insect and other cells. Yields of proteins made in eukaryotic cells (e.g. mammalian and insect cells) have traditionally not been as high as in expression systems based on simpler prokaryotic cells (e.g. bacteria). This is due in large part to limitations in the growth of complex cells compared to single-celled organisms. Until now, the total quantity of organic matter produced (the biomass) during bacteria and yeast fermentation was about 10-times higher than in mammalian or insect cells. PSC developed and filed for patent protection on a scaleable manufacturing process that overcomes most of the limitations on the growth of insect and other complex cells. The breakthrough gives up to ten-fold increases in biomass with similar improvements in the yield of recombinant proteins. PSC has achieved record yields of non-secreted recombinant proteins by combining its expresSF+® cells with high-density fermentation and has demonstrated that its process can be scaled to at least the 50-liter level (commercial scale for some vaccines). Although it has limited experience in producing secreted proteins at high-density, recent success with such proteins increases the likelihood that high-density will be the system of choice for most BEVS production. Based on initial PTO review, PSC believes it will receive protection for this invention.
- Low cost media
PSC developed a proprietary media formulation that significantly reduces the cost of media, which is the second most costly component in making proteins in insect cells (after capital costs). Producing proteins in expresSF+® cells at high-density using such media can reduce the cost of production by as much as 70%.
- Processing and purification know-how
PSC developed proprietary down-stream processing and purification techniques that are generally applicable to recovering purified recombinant proteins produced using BEVS. Biotechnology and pharmaceutical companies as well as academic researchers have experimented with insect cells, but have had difficulty in recovering proteins because the protocols used in traditional manufacturing systems do not work well with insect cells. PSC has developed proprietary methods that circumvent these problems and believes that its experience and proprietary techniques allow it to purify proteins at a cost that is much lower than its competitors.
- Recombinant hemagglutinin (rHA) (US Patents No. 5,762,939 issued in 1998 and No. 5,858,368 issued in 1999).
rHA is a potential replacement for the current licensed influenza vaccines that are produced in eggs. PSC's rHA has completed several Phase I and II human clinical trials that show safety and efficacy. The initial target market is the elderly, where the current licensed vaccine is less effective than in other populations. Since the U.S. National Institutes of Health has traditionally funded clinical trials of new influenza vaccines, the cost of completing such trials will be primarily the cost of manufacturing the product.
- Recombinant neuraminidase (rNA) (US Patent No. 5,976,552 issued in 1999).
rNA has completed Phase I and II clinical trials that showed safety and, when combined with the current licensed vaccine, demonstrated a significant increase in the level of antibodies and, for vaccinated people who become infected, less viral shedding and shorter duration of illness compared to the licensed vaccine alone - comparable to neuraminidase inhibitors.
- Recombinant hemagglutinin for veterinary use (US Patents No. 5,762,939 issued in 1998 and No. 5,858,368 issued in 1999).
Targets are primarily the swine, equine and avian markets. PSC has worked with several animal health companies that have tested its influenza vaccines in chickens, pigs and horses, and in each case the vaccines showed efficacy.
- Insect cells or cell fractions as adjuvants for antigens (US Patent No. 6,224,882 issued 2001).
A PSC collaborator tested the adjuvant in cats and the results were promising - high effectiveness without side effects. With an issued patent, PSC expects that there will be increased interest by potential licensees.
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