Greatly Enhanced Software Provides Necessary Features for GMP Compliance and Ensures Highly Reproducible Sample Preparation for Quality Control of Biotherapeutics
Pressure BioSciences, Inc. (PBIO), a leader in the development and sale of innovative, broadly enabling, pressure-based products and services for the worldwide life sciences industry, today announced the release of extensively redesigned software for its Barocycler 2320EXTREME instrument (the “2320EXT”). This software enhancement was the result of a year-long effort between the PBI Team and customers at one of the world’s largest biopharmaceutical companies, and makes the 2320EXT one of the few Good Manufacturing Practices (“GMP”) compliant (21 CFR Part 11), computer-controlled, sample preparation systems available in the worldwide life sciences market today.
GMP is a complex and interdisciplinary system that helps ensure that products are consistently produced and controlled according to quality standards. GMP covers all aspects of production, from starting materials to the final released product. Detailed procedures and records are essential for each process that could affect the quality of the finished product. Having GMP-compliant features should allow the Barocycler 2320EXT to be used in multiple departments within the same company, and for multiple applications well beyond extraction and protein digestion, where the instrument is primarily used today.
Based on the Company’s patented pressure cycling technology (“PCT”) platform, the Barocycler 2320EXT has been installed in research and manufacturing laboratories worldwide. The 2320EXT is primarily used in the preparation of samples (tissues, cells, proteins, etc.) for analysis. Sample preparation is often complex, time-consuming, and one of the most error-prone steps in scientific research. Nevertheless, it is a critical and universally-used laboratory undertaking, the requirements of which drive a large and growing market, estimated currently at $6 billion worldwide.
“The Barocycler 2320EXT, together with associated consumables and protocols, have been optimized specifically for the rapid and reproducible quality control (“QC”) of biotherapeutics, such as monoclonal antibodies (“MAbs”) and antibody-drug conjugates (“ADCs”),” said Dr. Alexander Lazarev, VP of R&D at PBI. “The new software provides a means of tracking each process parameter (e.g., pressure, temperature, time) in a secure format with a date and time stamp. It enables secure data storage, user management, and audit trails needed to comply with requirements of GMP in the biopharmaceutical manufacturing environment. In essence, the 2320EXT offers rapid and reproducible sample preparation for the characterization and quality control of biotherapeutics, now coupled with the assurance of GMP ready software control, achieving a pivotally important requirement for the biopharmaceutical industry.”
Dr. Nathan Lawrence, VP of Sales and Marketing at PBI, commented, “We are excited to now offer GMP-compliant software on our award-winning, next-generation Barocycler 2320EXT. This capability is extremely important to biopharmaceutical companies worldwide. Our new software provides the documented proof required by GMP regulations and guidelines that proper sample preparation procedures were followed throughout the entire process of bringing a new biopharmaceutical to market, including all phases of discovery, design, development, manufacturing, and QC.”
Dr. Lawrence continued, “GMP compliance is not only mandated by the U.S. Food and Drug Administration and equivalent regulatory bodies worldwide, it is also widely accepted by the world’s biopharmaceutical companies as the best – if not the only – way to bring a new product to market. We believe that the addition of our new GMP-compliant software and other added features now available with the Barocycler 2320EXT give our current and future biopharma customers the tools they need to comply and excel in this highly regulated industry.”
Roxana McCloskey, Director of Sales and Marketing – North America, added, “We believe the new GMP compliant software will significantly expand the utility of the Barocycler 2320EXT within the biopharmaceutical market. Over the past few years, PCT has become an enabling technology in many discovery labs. It will now be exciting to watch the PCT platform expand past discovery and into the multiple QC workflows required in the design, development, and manufacture of a final product. With new software and streamlined protocols, we believe multiple labs in the same facility will find the 2320EXT to be very beneficial to their work and that this will translate into a significant increase in sales of instruments and consumables in 2018.”
About Pressure BioSciences, Inc.
Pressure BioSciences, Inc. (“PBI”) (OTCQB: PBIO) develops, markets, and sells proprietary laboratory instrumentation and associated consumables to the estimated $6 billion life sciences sample preparation market. 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. Our primary focus is in the development of PCT-based products for biomarker and target discovery, drug design and development, bio-therapeutics characterization, soil & plant biology, forensics, and counter-bioterror applications. Additionally, major new market opportunities are emerging for PBI in (i) the use of our recently acquired PreEMT technology from BaroFold, Inc. to allow immediate entry into the biologics contract research services sector, and (ii) the use of our recently-patented, scalable, high-efficiency, pressure-based Ultra Shear Technology (“UST”) to create stable nanoemulsions of otherwise immiscible fluids (such as oils and water, fluoropolymers and alcohol, etc.), and to 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.
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