Posted on Thu, May 16, 2013
Company hosts live demonstrations of the Growth Direct™ System
Bedford, MA and Freising, Germany - (5/15/2013) – Rapid Micro Biosystems, a leading provider of automated, non-destructive, rapid microbial detection, today announced the opening of a state-of-the-art microbiology laboratory and headquarters located in Freising, just outside of Munich, Germany.
The new location provides office and applications development space as well as a dedicated laboratory environment for showcasing the new range of the Growth Direct™ System - the company’s automated, rapid, non-destructive microbial enumeration device - in a lab environment. Located within 20 minutes of the Munich airport, the facility is easily accessed by public transportation.
Rapid Micro Biosystems will host one-day workshops showcasing the Growth Direct™ System and its applications for sterility, environmental monitoring, water and bioburden testing. The full day workshop will include a live, hands-on demonstration of the system and sample preparation techniques as well as presentation of testing and validation data. A schedule of upcoming workshops is available at www.rapidmicrobio.com\workshops.
“We are excited about the new facility because it provides an opportunity for companies that want to accelerate and automate their microbial testing to gain experience with the system and the range of applications. We see this as the best approach to demonstrate the unique value that the Growth Direct™ can bring to businesses,” said Christof Hasse, Rapid Micro Biosystems’ European Sales Manager.
For more information about the facility, or to register for an upcoming workshop, visit www.rapidmicrobio.com.
Posted on Tue, Apr 16, 2013
Accreditation for Quality Management System for Design, Manufacture, Installation and Service of the Growth Direct™ System
Bedford, MA (April 16, 2013) – Rapid Micro Biosystems, the provider of rapid, automated, non-destructive detection and enumeration technologies in microbiology, today announced it has been awarded the International Organization for Standardization 9001:2008 certification for its Quality Management System.
Rapid Micro Biosystems received its ISO 9001:2008 certification from TÜV SÜD America Inc, a globally recognized testing, inspection and certification organization. The new certification verifies that the Rapid Micro Biosystems’ quality system and processes across the company’s operations and manufacturing meets the rigorous requirements and comprehensive reviews of ISO 9001:2008 certification.
“This certification demonstrates our commitment to delivering the highest quality products and services to our customers, “said Don Keren, Director of Quality at Rapid Micro Biosystems.
“Our products are used for quality control of pharmaceutical products, so it’s critical that our customers can be confident that they are partnering with a company committed to meeting or exceeding their needs,” said Rapid Micro Biosystems’ CEO, Steve Delity. “Completion of our certification process validates that we are not only a provider of innovative technology but a company dedicated to quality throughout our operation. “
For more information about Rapid Micro Biosystems and the Growth Direct™ System, or to attend a hands-on workshop, visit www.rapidmicrobio.com.
Posted on Fri, Oct 26, 2012
Single instrument supports concurrent testing of multiple applications
Bedford, MA (October 22, 2012) – Rapid Micro Biosystems, the provider of rapid, automated, non-destructive detection and enumeration technologies in microbiology, today announced the 2013 availability of the next generation of Growth Direct™ applications. The new system will support environmental monitoring testing, sterility testing, water testing and bioburden testing within the same instrument using the proven detection technology.
With the introduction of the Growth Direct™ system for multiple applications, the Rapid Micro Biosystems product portfolio expands to include 3 instrument systems and 4 specific applications:
- The Growth Direct™ System for Environmental Monitoring which automates the high volume testing typically found in the combination of air, surface and personnel monitoring.
- The Growth Direct™ System for Sterility which revolutionizes pharmaceutical microbial quality control testing while adhering to the stringent regulatory requirements of sterility testing.
- The Growth Direct ™System for multiple applications which supports all the tests above plus product bioburden and water testing on a single device.
These new systems and applications build on the existing Growth Direct™ technology platform currently used in FDA regulated manufacturing facilities. Sample preparation mimics the existing method. Once samples are loaded, the system uses the natural auto-fluorescence of the living cells to automatically detect, analyze and enumerate growing colonies. The test is non-destructive and uses no reagents, ensuring the availability of the sample for identification. User configurable software allows for the creation of alerts on out-of-specification samples, with reporting in colony forming units (CFUs.) The system software is easy to use in modes ranging from totally manual to paperless via the laboratory information system (LIMS.)
“The ability to provide all key microbial tests using a non-destructive, rapid method on a single, automated system will revolutionize quality control in pharmaceutical manufacturing. Businesses will be able to react quickly to contamination events while increasing productivity and standardizing their QC processes,” said Steve Delity, President and CEO of Rapid Micro Biosystems.
The new systems and applications will be available in the first half of 2013. Rapid Micro Biosystems will be exhibiting the Growth Direct System on October 22nd and 23rd at PDA’s 7th Annual Global Conference on Pharmaceutical Microbiology.
Visit www.rapidmicrobio.com for more details.
Contact:
Mark Severns
Rapid Micro Biosystems
mseverns@rapidmicrobio.com
Posted on Tue, Oct 02, 2012
Bedford, MA – (September 26, 2012) – Rapid Micro Biosystems, a leading provider of automated, non-destructive, rapid microbial detection, today announced the exercise of the third and final year contract option by the Biomedical Advanced Research and Development Authority (BARDA) for the development of rapid sterility testing as part of BARDA’s Science and Technology Platforms Applied to the Medical Countermeasure (MCM) Development program.
Rapid Micro Biosystems will receive $2.4 million for the third contract year. The third contract year runs through Q3 2013. With the third year renewal, Rapid Micro Biosystems has received the total contract value of $6.7 million.
“Our continuing relationship with BARDA demonstrates the critical need for rapid sterility testing as part of pandemic response,” said Steve Delity, Chief Executive Officer of Rapid Micro Biosystems.
“We are pleased with the results of our automated, rapid sterility test thus far,” said Sarath Krishnaswamy, Vice President of Research & Development. “Our unique detection technology starts to show contamination detection within hours and provide final enumeration results in 50% of the time of the traditional 14 day test.”
Reducing the time-to-release of vaccines or other biopharmaceutical countermeasures will facilitate the prevention and control of epidemic diseases like influenza, other emerging infections and agents of bioterrorism. Faster microbiological quality control (QC) testing will reduce the release cycle of vaccines by as much as two to four weeks.
About Rapid Micro Biosystems
Rapid Micro Biosystems, headquartered inBedford,Massachusetts, provides innovative products for faster, automated detection of microbial contamination in the manufacture of pharmaceutical, biotechnology, and personal care products. The Company’s Growth Direct™ System detects contamination earlier, delivering compelling economic benefits to manufacturers while improving their quality process. The Growth Direct™ System is the first and only automated system that accelerates testing, fits with current regulatory practices, and addresses all key applications. For more information, visit www.rapidmicrobio.com.
Contact:
Mark Severns
Rapid Micro Biosystems
mseverns@rapidmicrobio.com
Posted on Wed, Jun 20, 2012
Preview of new applications improving the efficiency of microbial quality control processes while significantly reducing the time-to-result
Bedford, MA (June 20,2012) – Rapid Micro Biosystems, the provider of rapid, automated, non-destructive detection and enumeration technologies in microbiology, today announced a schedule for interactive workshops at their US headquarters focused on the Growth Direct™ Systems for Environmental Monitoring and Sterility Testing. These half day events will provide attendees the ability to interact directly with the new technologies and to have questions answered by key parties at Rapid Micro Biosystems.
The agenda for the event includes breakout sessions where users will handle the different technologies around automated sterility testing and environmental monitoring, including the cassettes, software and automated device.
”These workshops provide a tremendous opportunity for interested parties to see the Growth Direct™ Systems in action,” said Julie Sperry, Chief Commercial Officer at Rapid Micro Biosystems. “We are excited to provide participants with a sneak preview of our new, revolutionary technology.”
Attendance at the event is free, and space is limited. Available dates are posted on the Rapid Micro Biosystems website at www.rapidmicrobio.com/workshops
Contact:
Mark Severns
Rapid Micro Biosystems
mseverns@rapidmicrobio.com
Posted on Mon, Apr 16, 2012
New applications improve the efficiency of microbial quality control processes while significantly reducing the time-to-result
Bedford, MA (April 16th, 2012) – Rapid Micro Biosystems, the provider of rapid, automated, non-destructive detection and enumeration technologies in microbiology, today announced the 2013 availability of the next generation of Growth Direct™ applications. The tests are specifically designed for environmental monitoring and sterility applications in pharmaceutical quality control laboratories. Representing a quantum leap from the current sterility and environmental monitoring test methods, the applications are based on the detection of natural auto-fluorescence of microorganisms. The Growth Direct™ System requires no additional reagents to detect growing colonies.
The Growth Direct™ System for Environmental Monitoring automates the high volume testing typically found in the combination of air, surface and personnel monitoring.
- Two results in one: Positive results in hours, with continued incubation for final results in half the time of the compendial method.
- Large capacity: Designed to handle high numbers of samples per day.
- Added efficiency: Automated reading of all environmental monitoring tests and data transfer to laboratory information systems (LIMS) frees resources for higher value activities.
- Actionable reporting: System alerts users immediately and trending analysis uncovers developing problems.
- Non-destructive: Analysis is non-destructive, allowing for microbial identification.
The Growth Direct™ System for Sterility revolutionizes pharmaceutical microbial quality control testing while adhering to the stringent regulatory requirements of sterility testing. Features of the system include the following:
- Positive results in hours: Early, real-time detection of microbial contamination, allowing for faster response to contamination events.
- Non-destructive test: Samples with positive results can continue to grow for additional analysis of the micro organism colony.
- Closed-loop sample prep: Aseptic sample preparation and testing of both aerobic and anaerobic microbes.
- 7 days versus 14: The typical sterility test requires 14 days. The Growth Direct™ for Sterility will provide final results in about half the time.
- Quantitative results: An actual colony count (in colony forming units) is provided at the end of the test, with regular count updates throughout the test.
These new applications build on the existing Growth Direct™ technology currently used in FDA regulated manufacturing facilities. As with the Growth Direct™ System for Water and Bioburden, sample preparation mimics the existing method including the ability to integrate to a laboratory information management system (LIMS). Once samples are loaded, the system uses the natural auto-fluorescence of the living cells to automatically analyze and enumerate any growing colonies. User configurable software allows for the creation of alerts on out-of-specification samples, with reporting in colony forming units (CFUs.) The test is non-destructive and uses no reagents, ensuring the availability of the sample for identification.
“These new applications for automated, rapid sterility and environmental monitoring testing address critical microbial quality control testing needs in pharmaceutical manufacturing. Businesses will be able to react quickly to contamination events while increasing productivity and standardizing their QC processes,” said Steve Delity, President and CEO of Rapid Micro Biosystems.
The new systems and applications will be available in the first half of 2013.
Posted on Mon, Oct 24, 2011
Bedford, MA – (October 17, 2011) – Rapid Micro Biosystems, a leading provider of automated, non-destructive, rapid microbial detection, today announced the exercise of the second year contract option by the Biomedical Advanced Research and Development Authority (BARDA) for the development of rapid sterility testing for vaccines as part of BARDA’s Science and Technology Platforms Applied to the Medical Countermeasure (MCM) Development program.
Rapid Micro Biosystems will receive $2.1 million for the second contract year. The second contract year runs through Q3 2012 with a final option available for funding a third contract year at $2.4 million.
“We are excited to continue our relationship with BARDA,” said Steve Delity, Chief Executive Officer of Rapid Micro Biosystems. “Rapid Micro is the leader in automated rapid detection, and we have made great strides in our ongoing development of a solution to help with pandemic response.”
“The development of the rapid sterility products is progressing very well,” said Sarath Krishnaswamy, Vice President of Research & Development. “Using our unique detection technology, we already have exciting test results that start to show contamination detection within hours and provide final enumeration results in 50% of the time of the traditional 14 day test.”
Reducing the time-to-release of vaccines or other biopharmaceutical countermeasures will facilitate the prevention and control of epidemic diseases like influenza, other emerging infections and agents of bioterrorism. Faster microbiological quality control (QC) testing will reduce the release cycle of vaccines by as much as two to four weeks.
About Rapid Micro Biosystems
Rapid Micro Biosystems, headquartered in Bedford, Massachusetts, provides innovative products for faster, automated detection of microbial contamination in the manufacture of pharmaceutical, biotechnology, and personal care products. The Company’s Growth Direct™ System detects contamination earlier, delivering compelling economic benefits to manufacturers while improving their quality process. The Growth Direct™ System is the first and only automated system that accelerates testing, fits with current regulatory practices, and addresses all key applications. For more information, visit www.rapidmicrobio.com.
Posted on Tue, Jun 21, 2011
Bedford, MA - (21 June, 2011) – Rapid Micro Biosystems, a leading provider of non-destructive, rapid microbial detection, today announced the opening of a state-of-the-art demo center located in Darmstadt, Germany.
The new space provides a dedicated demonstration environment for showcasing
the Growth Direct™ system - the company’s automated, rapid, non-destructive microbial enumeration device - in a simulated lab environment.
The center will exhibit automated rapid detection and its value to the microbial QC user. In addition to the demonstration space, the facility also includes a spacious conference room and reception area for visitors.
“We are excited about the new facility and look forward to the opportunity to demonstrate to those companies that want to accelerate and automate their microbial testing the unique value that Growth Direct™ can bring to businesses,” said Christof Hasse, Rapid Micro Biosystems’ European sales manager.
“The European Market is integral to our success, and this demo center enhances our commitment to Europe,” said Steve Delity, CEO of Rapid Micro Biosystems.
The new facility is located in Darmstadt, Germany, approximately 26 kilometers from the Frankfurt airport. For more information about the facility, or to schedule a demonstration of the Growth Direct system, visit www.rapidmicrobio.com.
About Rapid Micro Biosystems
Rapid Micro Biosystems, headquartered in Bedford, Massachusetts, provides innovative products for faster detection of microbial contamination in the manufacture of pharmaceutical, biotechnology, and personal care products. The Company’s Growth Direct™ System detects contamination earlier, delivering compelling economic benefits to manufacturers while improving their quality process. The Growth Direct™ System is the first and only automated system that accelerates testing, fits with current regulatory practices, and addresses all key applications. For more information, visit www.rapidmicrobio.com.
Posted on Thu, May 19, 2011
Bedford, MA - (May 19, 2011) – Rapid Micro Biosystems, a leading provider of non-destructive, rapid microbial detection, today named Michael J. Mullen Chief Financial Officer. Mullen will lead the financial planning, accounting, human resources, supply chain and IT functions for the business. He will report directly to the CEO, Steve Delity.
Mr. Mullen brings more than 30 years experience managing the financial endeavors in biotechnology and pharmaceutical instrument businesses. Prior to his role as Chief Financial Officer for Rapid Micro Biosystems, Mullen was an interim CFO with Valeritas, Inc. and CFO with Magellan Biosciences. While serving as CFO at Magellan Biosciences he implemented a comprehensive program of strategic acquisitions and divestitures which drove significant improvements in revenue and EBITDA.
Mullen was a co-founder and partner at JMH Capital, and has also held senior financial management roles with PerkinElmer, Inc, and Thermo Optek. Mullen graduated from James Madison University in Harrisonburg, VA, with a BBA in accountancy.
“We are excited to have Michael join our executive team,” said CEO Steve Delity. “His experience and knowledge in the pharmaceutical and biotech industry combined with his expertise in growing businesses will be integral to Rapid Micro Biosystems long-term objectives.”
Mullen commented: “I am privileged to join Rapid Micro Biosystems at an inflection point in the company’s history. I am impressed with the business’ performance thus far and am eager to play a role in the company’s plans forward.”
About Rapid Micro Biosystems
Rapid Micro Biosystems, headquartered in Bedford, Massachusetts, provides innovative products for faster detection of microbial contamination in the manufacture of pharmaceutical, biotechnology, and personal care products. The Company’s Growth Direct™ System detects contamination earlier, delivering compelling economic benefits to manufacturers while improving their quality process. The Growth Direct™ System is the first and only automated system that accelerates testing, fits with current regulatory practices, and addresses all key applications. For more information, visit www.rapidmicrobio.com.
Contact:
Mark Severns
Rapid Micro Biosystems
781-271-1444
mseverns@rapidmicrobio.com
Posted on Tue, Feb 08, 2011
Businesses team to accelerate microbial detection and identification.
Bedford, MA - (February 8, 2011)– Rapid Micro Biosystems, a leading provider of automated, non-destructive, rapid microbial detection, today announced a sales and marketing agreement with Life Technologies Corporation, a provider of innovative life science solutions. For quality control microbiology customers, the agreement combines best in class automated microbial detection and enumeration with gold-standard microbial identification.
The agreement leverages the strengths of both companies, benefiting customers who struggle daily with time consuming, manual processes, and product safety testing where accuracy and time to results are critical. The goal of the agreement is to maximize industry adoption of the complementary technologies. The Growth Direct™ System from Rapid Micro Biosystems enables rapid microbial detection, and the MicroSEQ® Rapid Microbial Identification System from Life Technologies facilitates accurate bacterial and fungal identification.
“We are excited with the opportunity this alliance presents to our customers,” said Steve Delity, Chief Executive Officer of Rapid Micro Biosystems. “Rapid Micro is the leader in automated rapid detection, and through our collaboration with Life Technologies, the leader in microbial identification, we create a compelling value proposition for the marketplace.”
“The agreement with Rapid Micro Biosystems is part of our larger commitment to address the needs of microbiologists in product quality and safety testing,” said Tony Hunt, General Manager of Pharma Analytics at Life Technologies. “We are pleased to add the Growth Direct™ System for microbial detection to our overall microbiology portfolio.”
For more information, visit http://www.rapidmicrobio.com/automated_sample_control
About Rapid Micro Biosystems
Rapid Micro Biosystems, headquartered in Bedford, Massachusetts, provides innovative products for faster, automated detection of microbial contamination in the manufacture of pharmaceutical, biotechnology, and personal care products. The company’s Growth Direct™ System detects contamination earlier, delivering compelling economic benefits to manufacturers while improving their quality process. The Growth Direct™ System is the first and only automated system that accelerates testing, fits with current regulatory practices, and addresses all key applications. For more information, visit www.rapidmicrobio.com.
Contact:
Mark Severns
mseverns@rapidmicrobio.com
781-271-1444 x 267
