International Biopharma Client to Evaluate PBI's Patented PreEMT™ Platform to Enhance Manufacturing Process and Improve Quality of Key Protein Therapeutic Drug Candidate
SOUTH EASTON, MA / ACCESSWIRE / May 3, 2018 / Pressure BioSciences, Inc. (OTCQB:PBIO) ("PBI" and the "Company"), a leader in the development and sale of innovative, broadly enabling, high pressure-based instruments and related consumables for the worldwide life sciences industry, today announced that it has signed an agreement with an international biopharmaceutical company to assess the potential of the Company's recently acquired PreEMT™ platform to develop a unique manufacturing process and improve the quality of a key protein-based drug currently under development.
Protein-based therapeutic drugs are an important part of the global healthcare industry. Based on data in the THPdb database (http://crdd.osdd.net/raghava/thpdb/), there are over 200 therapeutic proteins and peptides approved for clinical use in the US. These drugs have significantly changed therapy options for many diseases, such as cancer and blood disorders. They are the preferred treatment choice for hormone and growth factor deficiencies and are an ideal treatment option for autoimmune disorders. According to a report from Research and Markets (May 2016), the global protein drug market will reach approximately $248 billion by 2020.
Unfortunately, the manufacture of therapeutic proteins is difficult and complex. According to a report in F1000 Research(Lagasse, Feb 2017), producing a typical protein drug may include more than 5,000 critical process steps. Consequently, even in the best of laboratories, it is not unusual for protein therapeutics to fail in manufacturing. High on the list of reasons for failure are the formation of protein aggregates and the misfolding of the therapeutic protein during the manufacturing process.
Dr. Alexander Lazarev, Vice President of R&D, said: "PreEMT is a patented technology that employs high pressure for the disaggregation and controlled refolding of proteins to their native structures at yields and efficiencies not achievable using existing technologies. PreEMT results in the dissolution of protein aggregates, which may have a significant impact on the quality of protein drugs by improving protein activity, homogeneity, and stability, as well as by reducing undesirable immunogenic properties."
Dr. Lazarev continued: "PreEMT can be applied to many therapeutic proteins. It can be used to reduce aggregate levels in bulk or final formulations, thereby improving product safety. It is scaleable and practical for standard manufacturing processes. Thus, we believe this unique technology platform can help protein-based biopharmaceutical companies create and manufacture high quality novel protein therapeutics and lower the cost of existing formulations."
Dr. Nate Lawrence, Vice President of Marketing and Sales commented: "We purchased all assets of BaroFold, Inc. less than five months ago. The development of our Biologics Contract Services Group and associated PreEMT application protocols have just been established at PBI. We are still developing a comprehensive worldwide marketing campaign for the PreEMT platform. To have an international biopharmaceutical company developing protein-based drugs approach us so soon after the purchase of the BaroFold IP estate, says a lot to us about the current needs of protein drug manufacturing and the reputation that the PreEMT platform has already gained in this area."
Mr. Richard T. Schumacher, President and CEO, said: "We believe this contract will take three to four months to complete. Moreover, we have recently been contacted by several additional biopharmaceutical companies interested in evaluating our PreEMT disaggregation and refolding service in the development and manufacture of protein-based therapeutics. Because of this early interest in the PreEMT platform, and because the BaroFold pressure-based technologies work on and will help sell our existing Barocycler instrumentation, we believe the BaroFold asset purchase will pay for itself very quickly. Finally, and importantly, should the PreEMT technology result in more efficient production of high quality protein-based therapeutics for any biopharmaceutical company developing new protein-based therapeutics, manufacturing-scale licenses have the potential to generate millions of dollars in annual royalty revenue."
PreEMT ("Pressure Enabled Protein Manufacturing") is a patented technology that employs high pressure for the disaggregation and controlled refolding of recombinant proteins into their native structures for desired drug activity. The PreEMT technology platform is transformative and practical for biopharmaceutical manufacturing processes, offering substantially reduced production costs due to its increased process yield and throughput at high protein concentrations. The PreEMT technology is easily scalable and has been utilized for the cGMP production of phase 1 through phase 3 clinical materials.
About Pressure BioSciences, Inc.
Pressure BioSciences, Inc. (OTCQB:PBIO) is a leader in the development and sale of innovative, broadly enabling, pressure-based solutions for the worldwide life sciences industry. Our products are based on the unique properties of both constant (i.e., static) and alternating (i.e., pressure cycling technology, or "PCT") hydrostatic pressure. PCT is a patented enabling technology platform that uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels to safely and reproducibly control bio-molecular interactions (e.g., cell lysis, biomolecule extraction). Our primary focus is in the development of PCT-based products for biomarker and target discovery, drug design and development, biotherapeutics characterization and quality control, soil & plant biology, forensics, and counter-bioterror applications. Additionally, major new market opportunities have emerged in the use of our pressure-based technologies in the following areas: (1) the use of our recently acquired PreEMT™ technology from BaroFold, Inc. to allow immediate entry into the biologics contract research services sector, and (2) the use of our recently-patented, scalable, high-efficiency, pressure-based Ultra Shear Technology ("UST") platform to (i) create stable nanoemulsions of otherwise immiscible fluids (e.g., oils and water) and to (ii) prepare higher quality, homogenized, extended shelf-life or room temperature stable low-acid liquid foods that cannot be effectively preserved using existing non-thermal technologies.
Forward Looking Statements
Statements contained in this press release regarding PBI's intentions, hopes, beliefs, expectations, or predictions of the future are "forward-looking'' statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based upon the Company's current expectations, forecasts, and assumptions that are subject to risks, uncertainties, and other factors that could cause actual outcomes and results to differ materially from those indicated by these forward-looking statements. These risks, uncertainties, and other factors include, but are not limited to, the risks and uncertainties discussed under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2017, and other reports filed by the Company from time to time with the SEC. The Company undertakes no obligation to update any of the information included in this release, except as otherwise required by law.
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Richard T. Schumacher, President & CEO Pressure BioSciences, Inc.
Alexander Lazarev, Ph.D., VP of Research and Development (508) 230-1828 (T)
SOURCE:Pressure BioSciences, Inc.