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First ‘Adaptive Bioproduction Suite’ to Debut at Premier BioPharma Event
INTERPHEX to Showcase New Flexible Biopharmaceutical Production Platform
DAYTONA BEACH, FL; March 8th, 2017 – Germfree will introduce its Mobile Adaptive Bioproduction Suite on March 21, 2017 at International Pharmaceutical Expo (INTERPHEX), the premier event dedicated to pharmaceutical, biotechnology and device innovation, technology and knowledge from development through commercialization. This adaptive cleanroom trailer is the first of its kind to provide configurable space for cGMP production, R&D and biocontainment within a self-contained mobile platform. Accelerated innovation in the biopharmaceutical industry has generated a shift toward more flexible manufacturing environments. The Bioproduction Suite is a new approach for rapid deployment of cleanrooms and adaptable platforms for bioprocessing. INTERPHEX takes place March 21-23, 2017 at the Jacob Javits Center in New York, New York.
The 53’ (16 meter) stand-alone cGMP facility will be featured as a special event at INTERPHEX 2017. “INTERPHEX offers the ideal venue to demonstrate technologies that represent the future of pharmaceutical and biologics development and production,” said Melissa Ashley, Senior Vice President, INTERPHEX. “We are delighted that Germfree will exhibit a mobile adaptive bioproduction suite for attendees to walk through and experience solutions that maximize onsite space and offer personnel safety and containment control in a self-contained platform right on the show floor.”
Adaptive Bioproduction Suites are configured to meet the specific technical and validation requirements for each application. The units are ideally suited to adjust for emerging biopharmaceutical processes as they utilize Germfree’s interchangeable casework and laminar flow equipment. The Bioproduction Suite will be presented at INTERPHEX as a concept cleanroom facility. Specialty bioprocessing equipment will be integrated from many exhibiting partners including: Eppendorf, Getinge, Rotronic Instrument Corporation, STERIS Barrier Product Solutions, STERIS, Thermo Fisher Scientific, Carltex, BMT USA and TSI Inc.
“The pharmaceutical industry is under intense pressure to adapt production processes and facilities that keep up with the rapid pace of innovation.” said Jeff Serle, Senior Vice President, Germfree. “We’ve developed the Adaptive Bioproduction Suite to provide the next level of flexibility. It was also critical for our platform to be engineered as a self-contained, stand-alone facility that can be easily repurposed and relocated anywhere in the world.”
Germfree’s Adaptive Bioproduction Suites are optimal for a wide range of biopharmaceutical production applications including: monoclonal antibodies, therapeutic proteins, gene therapy, viral vector and live virus vaccines. Adaptive trailers offer flexible cleanroom space that is easily configured to required ISO grades as well as biological safety levels up to BSL-3. These capabilities help facilitate the rapid development and clinical trial manufacturing processes that are critical to product pipeline success.
“The Adaptive Trailers provide new options for fast and flexible cGMP/biocontainment production space that would be impractical in a brick and mortar building.” Says Carol Houts, Director of Quality, Germfree. “These units will also allow biotechnology companies to solve small scale processing challenges especially for precision medicine.” Germfree’s technology will be demonstrated, together with product innovations from participating partner vendors in booth 3961 at the Jacob Javits Center in New York City.
Germfree designs and manufactures flexible bioproduction and R&D platforms. Our adaptive mobile suites and modular facilities provide advanced cGMP-compliant cleanrooms and biocontainment. We also integrate core equipment including our lines of interchangeable laminar flow hoods and containment equipment.
Germfree was established in 1962 to provide biosafety and aseptic control systems for institutions ranging from hospital pharmacies to high containment BSL-4 laboratories. We continue to expand and adapt our technologies. For the past 17 years, Germfree has manufactured mobile and modular BSL-3 labs to meet the rigorous demands of military and public health institutions globally, with facilities deployed to the harshest environments. This engineering experience makes us uniquely qualified to provide cleanroom platforms that offer quality, safety and durability that exceed traditional facilities. Our leading-edge fabrication technology, engineering teams and subject-matter experts are located at our 173,000 square foot (16,000 square meter) US manufacturing plant.
For the past 38 years, INTERPHEX has been, and continues to be, the premier pharmaceutical, biotechnology, and device development and manufacturing event where you can “Experience Science through Commercialization.” Sponsored by the Parenteral Drug Association (PDA), the event is based in New York and brings over 11,500 global industry professionals and 625+ industry leading suppliers together to “Learn it, Experience it, Procure it” through a unique combination of no cost technical conference, exhibits, demonstrations, workshops, partnering opportunities and networking to leverage quality, efficiency and cost effectiveness in today’s ever-changing global market. INTERPHEX offers annual domestic and international industry events and educational opportunities around the world. For more information, please visit INTERPHEX.com.
With headquarters in New York, we are a subsidiary of Eppendorf AG (Hamburg, Germany) – manufacturer of laboratory instruments and consumables for the life sciences. You’ll see Eppendorf products used in all types of life science research and testing settings – from basic laboratory applications to highly specialized cell and molecular biology applications. They are highly regarded for their quality design and performance – beginning with extensive research and development, adding state-of-the-art technology and ending with strict quality-controlled manufacturing are what make our products stand out from the rest. It is what has made us a brand you have been able to rely on for over 70 years. For more information, please visit eppendorf.com
Getinge Group is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. The aim is to be the most desired medtech company in the world. Getinge’s offering is mainly targeted at care providers, care givers and care receivers. The offering to hospitals is organized in three areas: Enable, Treat and Care. This allows Getinge to identify customer issues at an early stage, promote clinical and economic benefits and follow and support the customer decision process. Getinge’s unique offering mirrors the hospital’s organization and value chain, and the solutions are used before, during and after the patients’ hospital stay. For more information, please visit getinge.com
The Rotronic Monitoring System (RMS) is the future of monitoring and it is available now. RMS is platform agnostic and makes it easy to access real-time monitoring data any time, from any place, on any device. The System is fully browser based and complies with all relevant regulations and guidelines. RMS is a modular system of hardware elements and web-based software. It provides maximum flexibility in installation and ensures readily available data. The data loggers record measurements from Rotronic and third-party sensors and transmit them to the secure database. It stores information and makes it available to users, regardless of whether they access the database via a PC, Mac, tablet or smartphone. RMS is perfect for both large monitoring systems and for simple, small applications. Rotronic makes the database available as a secure cloud account. Rotronic manufactures a full range of individual components and software for the monitoring system. We also offer professional advice, installation, commissioning and maintenance for the installed RMS. For more information, please visit rotronic.com.
STERIS Barrier Product Solutions, formerly General Econopak, Inc., provides solutions in the areas of aseptic technique, sterilization, cleanliness, and protection of personnel and equipment for the pharmaceutical, biotechnology, and allied markets. Among the many products designed and manufactured by STERIS Barrier Product Solutions are sterilization wrapping products, equipment/machine covers, cleanroom wipers and supplies, protective apparel, and cleanroom apparel packs. We are proud of our ability to provide products of excellent quality, supported by exceptional Customer service and delivery. The STERIS Barrier Product Solutions, GEPCO and Econ-o-Pak names are widely recognized by our Customers throughout the world. For over 40 years, STERIS Barrier Product Solutions has earned a reputation for expertise in solving our Customers’ toughest challenges and for providing delivery precisely when needed. We have validated manufacturing processes, certified cleanroom production capabilities, and documented technical data for all of our standard and custom designed products. For more information, please visit sterisbps.com
STERIS is a leading provider of infection prevention and procedural surgical products and services, focused primarily on healthcare, pharmaceutical, research and medical device Customers. Our mission is to provide a healthier today and a safer tomorrow through knowledgeable people and innovative infection prevention, decontamination and health science technologies, products and services. While the corporation was founded as Innovative Medical Technologies in 1985 and renamed STERIS in 1987, our history dates back to 1894 with the founding of American Sterilizer Company, a long-time, global leading innovator of sterilization products. Today, through a series of strategic acquisitions and continual innovation of new products, STERIS holds one of the broadest portfolios of products in the industry. It stands at the forefront of efforts to prevent infection and contamination in healthcare, pharmaceutical and medical device environments. For more information, please visit steris.com.
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $18 billion and more than 55,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit thermofisher.com.
Carltex Inc. is located in Nyack, NY with sales and support facilities. All sales are from the NY office. Now celebrating 19 years, Carltex supplies a wide variety of data acquisition, measurement & control, validation, and microscopy & imaging products. For More information, please visit carltex.com.
BMT USA is a member of the MMM Group; one of the world’s leading suppliers of process equipment with subsidiaries in over 20 different countries and manufacturing facilities in the USA, Germany and the Czech Republic. Since the beginning in 1954, the group’s sterile products have been placed in Pharmaceutical, Laboratory and Healthcare facilities throughout the world. Special attention is given to quality, reliability, innovation, and efficiency of every unit. Constant review, customer input, and our commitment to improvement helps ensure our products meet the constantly changing requirements and needs of our customers. We understand the important role of our products to research and production facilities, and we strive to provide the most reliable, state-of-the-art equipment available. Customer service excellence is our philosophy and our commitment to your organization. We believe this is the best way to achieve your continued business and is the key to our success. For more information, please visit bmtus.com.
TSI Inc. serves a global market by investigating, identifying and solving measurement problems. As an industry leader in the design and production of precision measurement instruments, TSI partners with research institutions and customers around the world to set the standard for measurements relating to aerosol science, air flow, chemical analysis, indoor air quality, fluid dynamics, biohazard detection, and even scrap metal sorting and plastics identification. With headquarters based in the U.S. and field offices throughout Europe and Asia, TSI has established a worldwide presence in the markets we serve. Every day, our dedicated employees turn research into reality. TSI has a worldwide presence with over 500 dedicated employees working in facilities in North America, Europe and Asia. Our corporate sales and service offices (St. Paul, Minnesota, USA; Aachen, Germany; High Wycombe, United Kingdom; Beijing, China; Shanghai, China; Singapore, and Bangalore, India) provide regional customer support. We also maintain a network of knowledgeable manufacturers’ representatives and distributors to provide local support worldwide. For more information, please visit TSI.com