purification of nucleic acids
WEST BRIDGEWATER, Mass., Aug. 21 /PRNewswire/ -- Boston Biomedica, Inc. (Nasdaq: BBII) today announced that it has been issued two additional patents by the United States Patent and Trademark Office for the use of its proprietary Pressure Cycling Technology (PCT) to sterilize biological materials and purify nucleic acids. The first patent, "Rapid Cryobaric Sterilization and Vaccine Preparation" (US Patent No. 6,270,723), describes the use of high pressure to sterilize materials such as vaccines, therapeutics, or blood plasma preparations without destroying the desired protein activities. The other patent, "Pressure Enhanced Extraction and Purification" (US Patent No. 6,274,726), includes claims to PCT methods and devices for purification of nucleic acids following their release from cells.
The sterilization patent describes how the cyclic use of high pressure at low temperatures can be used to inactivate viruses or bacteria while retaining the activity of many beneficial proteins such as coagulation factors, antibodies, and other therapeutic proteins in blood plasma and plasma derivatives, as well as in vaccines or therapeutics derived from cultured cells or recombinant sources. PCT allows far greater flexibility in choice of conditions that preferentially inactivate large structures such as viral coats or bacterial cell walls, without destroying smaller molecules that account for most of the desired therapeutic properties of these materials.
"The ability to eradicate both known and unknown pathogens in plasma, while retaining the biological activity of important plasma protein therapeutics, is an important area of research for the plasma fractionation industry," said Dr. Frederick Dombrose, Executive Director for the Consortium for Plasma Science. "The Consortium has taken an active role in supporting research on the application of PCT for inactivating viruses in plasma, because it offers many potential benefits in its applicability to a broad range of pathogens, ease of use, and scalability. This patent should provide BBI further protection in this area of pathogen inactivation."
The PCT extraction and purification patent describes conditions for release of nucleic acids from solid supports using high pressure without necessarily changing salt or solvent conditions. In addition, the new patent also covers the combination of high pressure with application of an electric field to release nucleic acids from their cellular environment. Both approaches greatly simplify the purification process without introducing additional materials that have to be subsequently removed, and both can be less destructive of nucleic acids than current purification methods, helping to ensure higher quality purified products.
"This patent enlarges our rapidly growing repertoire of proprietary methods for sample preparation, and complements the PCT sample preparation system currently scheduled for commercial release next year," commented Richard T. Schumacher, Founder, Chairman and CEO of Boston Biomedica. "The interest that we saw among our scientific and business colleagues when we successfully demonstrated the Barocycler and PULSE tubes at the American Association of Clinical Chemistry Annual Meeting earlier this month strengthened our belief that PCT can play an important future role in addressing the very real needs of the rapidly growing fields of proteomics and genomics, in addition to finding research and industrial applications in medicine, agriculture, and environmental testing. In particular, we believe that the PCT sample preparation system can make an important contribution to these markets."
These awards bring the total number of patents issued to BBI for the use of PCT to eight. Previously issued patents include claims covering the instrumentation, devices and methods designed to carry out the PCT process, release of nucleic acids or proteins from cells and tissue, purification of biological compounds, and sequencing or hybridization of nucleic acids.
Boston Biomedica, Inc. provides products and services for the detection and monitoring of infectious diseases such as AIDS and Viral Hepatitis. BBI has three operating business units: (1) BBI Diagnostics, an ISO 9001 certified manufacturer and supplier of quality control and diagnostics reagents used to increase the accuracy of in vitro diagnostic tests, (2) BBI Biotech Research Laboratories, a research and development center providing R&D support for the other BBI business units, as well as contract research and repository services for the government, industry and other third parties, and (3) BBI Source Scientific, an ISO 9001 certified manufacturer of diagnostic instrumentation and medical devices. In addition, BBI is conducting research and development in Pressure Cycling Technology (PCT) through its subsidiary BBI BioSeq, with the goal of introducing new solutions for a number of important healthcare issues, including: inactivation of pathogens in human plasma, extraction of nucleic acids, food safety, and genomics. BBI also maintains a passive investment in Panacos Pharmaceuticals, a privately held antiviral drug and vaccine development company recently spun-off from BBI, whose goal is to introduce new solutions for the treatment of infectious diseases.
Statements contained in this news release that state the Company's or management's intention, hopes, beliefs, expectations or predictions of the future are "forward-looking" statements. It is important to note that the Company's actual results could differ materially from those projected in such forward-looking statements. Factors that could cause actual results to differ from those projected include the possibility that, due to difficulties in the development of the technology, BBI may not be successful in developing pressure cycling technology into commercially viable products or services, including those in the area of sterilization and nucleic acid hybridization and amplification; that pressure cycling technology may not be adaptable to any other commercially viable applications; that certain pressure cycling applications may not fall within the claims of the Company's eight issued patents; and that individuals and groups utilizing such PCT procedures may not be required to license such technology from BBI. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements is contained from time to time in the Company's SEC filings, including but not limited to the Company's Annual Report on Form 10-K (as amended) for the year ended December 31, 2000, Current Report on Form 8-K filed March 8, 2001, Quarterly Report on Form 10-Q for the quarters ended March 31, 2001 and June 30, 2001, and in the Company's Registration Statements on Form S-3 (Reg. No. 333-46426 and Reg. No. 333- 94379). Copies of these documents may be obtained by contacting the Company or the SEC.
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SOURCE Boston Biomedica, Inc.
Web site: http: //www.bbii.com
CONTACT: Richard T. Schumacher, CEO & Chairman, or Kevin W. Quinlan, President & COO, of Boston Biomedica, Inc., +1-508-580-1900
