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Monday, May 12th, 2014

Disinfectant Qualifications in Pharmaceutical Manufacturing Environments is Focus of White Paper

AGAWAM, MASS. – May 12, 2014 – A white paper outlining the six steps that pharmaceutical and medical device manufacturers must employ to qualify disinfectants used in their environmental cleaning processes is available from Microtest Laboratories. It is available for download from http://microtestlabs.com/6stepspaper-disinfectant-qualification.

“Sterile pharmaceutical and medical device manufacturing environments require an effective cleaning and disinfection program to maintain aseptic conditions and prevent the microbial contamination of the product. The qualification of the chemical disinfectants used in these environments is extremely important, yet it is often overlooked,” stated Deborah Ensign, supervisor, R&D of Microtest Laboratories, in the new white paper, “Six Steps to Qualifying Disinfectants.”

In fact, “disinfectant qualifications require more planning, time, and resources than many companies realize,” she said.

“Any time a new disinfectant is introduced into the cleaning process within the facility, a qualification should be performed. From start to finish, a disinfectant qualification can require from 2 to 12 months.

“The timeline for a disinfectant qualification will depend on a number of variables, including the number of disinfectants and challenge organisms being tested as well as the number of surfaces (for the coupon method) being evaluated,” Ensign noted.

“The bottom line is that no matter whether the disinfectant qualification is performed internally — or by an outside testing laboratory — these six steps must be addressed,” she warned.

Download a free copy of the white paper, “Six Steps to Qualifying Disinfectants” for pharmaceutical manufacturing companies from http://microtestlabs.com/6stepspaper-disinfectant-qualification.

Deborah Ensign is supervisor, R&D Lab, at Microtest Laboratories Inc. She has over 20 years of experience in regulatory microbiology and contract laboratory operations. Ms. Ensign supervises Microtest’s Specialized Microbiology department. She holds a bachelor of arts degree in microbiology and is a nationally registered microbiologist. Ms. Ensign oversees all reusable testing (cleaning, disinfecting, and sterilization) and serves as a resource for USP testing, specifically <51>, <61>, and <62>.

About Microtest Laboratories

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.


Saturday, April 26th, 2014

Parenteral Drug Association to Discuss Rapid Micro Systems and Tour Microtest Laboratories on May 6th in Agawam, Mass.

AGAWAM, MASS. — April 28, 2014 — The New England Chapter of the Parenteral Drug Association (PDA) will feature “Rapid Micro Systems: A New Tool in Navigating the Stormy Seas of Biological Testing” at a May 6 meeting in Agawam, Mass. The meeting also will include a tour of Microtest Laboratories, a leading provider of life science testing services for pharmaceutical and medical device companies.

Keynote speakers at the meeting will include the following:

Dr. Bradford O. Fanger, Ph.D., field applications scientist at Azbil BioVigilant, will discuss “Reducing Manufacturing Risk with Rapid Microbiological Methods.” In his presentation, Dr. Fanger will provide an overview of rapid microbiological systems, the different types available, and their advantages.

James Gebo, senior research and development scientist, Microtest Laboratories, will review “Evaluation and Implementation of Rapid Microbiological Methods.” His presentation will explore the applications for rapid microbiological systems, review the business case for purchasing the technology, and explain ROI reporting.

The dinner meeting will be held at Kaptain Jimmy’s Restaurant and Distillery, 916 Suffield Street, Agawam. The Microtest tour will leave the restaurant at 4 p.m. Both PDA members and non-members are invited to attend.

To register, visit https://store.pda.org/Meetings/Login.aspx?ID=2273.

About the Parenteral Drug Association

The Parenteral Drug Association (PDA) is the leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 9,500 members worldwide. The New England Chapter was formed in 1988, and represents PDA members from the six New England states: Massachusetts, New Hampshire, Rhode Island, Vermont, Maine, and Connecticut.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Facebook at http://facebook.com/MicrotestLaboratories, on LinkedIn at http://goo.gl/H8ZLnM or on Twitter @MicrotestLabs.


Tuesday, March 11th, 2014

Webinar Exploring “What’s the Risk? Fearing the Failure in Environmental Monitoring Systems” is Offered for Life Science Companies

AGAWAM, MASS. — March 11, 2014 — A webinar to help life science companies explore the importance of a well-implemented and understood environmental monitoring program, and its ability to generate valuable data, will be offered on Wednesday, March 26, from 1:30 p.m. to 3:30 p.m. EST. The online event will identify the common mistakes and misconceptions regularly encountered when managers “fear the failure” of environmental excursions.

Environmental monitoring systems demonstrate that a company’s various contamination control strategies are operating properly. Such systems can illustrate whether operations are in a state of control. Variations in the data can indicate a drift which could potentially impact product and patient safety.

But the data generated by environmental monitoring system may become skewed when a culture is created which fears environmental failures or excursions. The webinar, What’s the Risk? Fearing the Failure in Environmental Monitoring Systems,” will detail how key life science company management can work to avoid such cultures.

Webinar topics — tailored for quality assurance and control, manufacturing, microbiology, and facilities management in pharmaceutical, biotech, and medical device organizations — will include:

  • The big picture: what systems need to be monitored and why the data is valuable
  • Risk-based environmental monitoring program implementation
  • Culture and “buy-in:” how to create a culture of employee acceptance for contamination control programs
  • Responding to data: how to identify trends in the data and respond with appropriate actions

The webinar will be offered Wednesday, March 26, 1:30 p.m. to 3:30 p.m. EST. Featured speakers include Valerie Montgomery, environmental services manager, and Alison Zulick, environmental services leader, both of Microtest Laboratories, a leading provider of testing services and contract manufacturing for the life science industries.

To register or for more information about the webinar, What’s the Risk? Fearing the Failure in Environmental Monitoring Systems,” visit http://www.microrite.com/training/environmental-monitoring-systems-fearing-the-failure.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and compounding pharmacy industries. Based in Agawam, Massachusetts, USA, Microtest leverages its 30 years industry experience to help its clients meet their regulatory requirements.  For more information, visit http://www.microtestlabs.com or toll-free 1-800-631-1680.

 

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Press contact: Don Goncalves, 1-781-793-9380, dgoncalves@tizinc.com


Tuesday, January 21st, 2014

Brooks Introduces Next-Generation Automated Sample Storage Systems; Feature-Rich, Flexible, Reliable Technology in a Standardized Platform

Brooks SampleStoreTM II system

CHELMSFORD, MASSACHUSETTS, January 21, 2014 — Brooks Life Science Systems, a division of Brooks Automation, Inc. (Nasdaq:BRKS), has introduced its next-generation of automated systems for sample and biological storage. The systems include standardized control software that offers a best-in-class user experience. The company also launched its new “Ask Brooks” expert services portal.

The announcements were made at the Society for Lab Automation and Screening’s 2014 annual conference.

“Our next-generation automated storage systems establish new industry standards for flexibility and reliability,” said Christopher McNary, vice president and chief commercial officer, Brooks Life Science Systems. “We’ve drawn upon the best technologies developed over Brooks’ 15 years of automated storage market leadership to design a storage platform that is highly adaptable to customer needs over the lifetime of the system.”

The flexibility in Brooks’ new sample storage platform comes from its modular architecture and control software. Each system has six bays that can be populated with the industry’s widest range of modules for picking, imaging, and input/output functions. Additional sample banks can be added to the initial system via an internal bridge for future expansion. The control software offers simplified operation and installation. This versatility makes the platform easy to configure and operate, plus highly scalable to meet changing customer requirements.

“We’re leveraging Brooks’ long history in the semiconductor industry where highly reliable products have been a standard requirement for decades,” said McNary. “We incorporate this high level of reliability in our automated storage platforms to improve system uptime for the life science market.”

Built-in Dynamic Storage Optimization technology allocates storage space whenever samples are loaded, eliminating the need to predefine the mix of sample containers. High-density trays increase tube storage up to 65% in the same footprint versus 96-tube racks. A high-throughput configuration can process over 100,000 tube picks per day.

The new standardized sample storage platform consists of the following components:

  • SampleStoreTM II system: for dry powder, small molecule, and DNA samples from room temperature to -20° C with 300,000- to over 10 million-tube storage capacity
  • BioStoreTM II system: for biological sample storage to -80° C with 700,000- to 5 million-tube storage capacity
  • StrataTM automated control software: easy-to-operate and configure icon-based interface with mobile device accessibility. Simple integration with IT/LIMS systems, plus intelligent diagnostics enhances reliability.

“We’ve established a new benchmark for automated sample storage by offering the best user experience, highly flexible configuration, and ultra-reliable operation,” said McNary. “This ensures our customers can meet the changing needs of their applications – from compound storage for drug discovery to DNA, tissue, and blood serum storage for biobanking.”

The company said the first commercial systems are being installed in customer facilities and that orders can be placed immediately with Brooks’ sales representatives.

“Ask Brooks” to Provide Automated Sample Storage Expertise

Brooks also announced it has launched Ask Brooks (http://www.brooks.com/ask-brooks) as part of a new strategic advisory services offering. The Web portal will allow automated sample storage users to question Brooks’ experts about any problems or issues they are facing.

“With over 250 storage systems in place, over 1 billion samples under management, and the industry’s largest engineering staff, we are uniquely qualified to answer tough questions and solve difficult problems,” McNary said. “We encourage sample storage professionals to use the new Web portal when they face challenging applications.”

Users simply type their questions into the form on the Ask Brooks portal and Brooks’ experts will promptly respond.

About Brooks Automation

Brooks is a leading worldwide provider of automation, vacuum, and instrumentation solutions for multiple markets including semiconductor manufacturing, life sciences, and clean energy. Our technologies, engineering competencies, and global service capabilities provide customers speed to market, and ensure high uptime and rapid response, which equate to superior value in their mission-critical controlled environments. Since 1978, we have been a leading partner to the global semiconductor manufacturing market and through product development initiatives and strategic business acquisitions; we have expanded our reach to meet the needs of customers in the life sciences industry, analytical & research markets, and clean energy solutions. Brooks is headquartered in Chelmsford, MA, with direct operations in North America, Europe, and Asia. For more information, please visit www.brooks.com.


Tuesday, January 14th, 2014

Fundamentals of Endotoxin Testing for Medical Device Manufacturers are Detailed in New Technical Brief

AGAWAM, MASS. — January 14, 2014 — The fundamentals of endotoxin testing for medical device manufacturers — from definition to assay acceptance criteria —are detailed in new technical brief available from Microtest Laboratories.

Bacterial endotoxins cause fever, septic shock, and other disease symptoms — and thus attract considerable regulatory scrutiny from such organizations as the U.S. Food & Drug Administration (FDA) and the United States Pharmacopeial Convention. Regulations require that devices that contact circulating blood or cerebrospinal fluid, or are used with intraocular products or in vitro fertilization procedures, are required to be endotoxin-free.

The Fundamentals of Endotoxin Testing,” available for download at http://microtestlabs.com/endotoxin-testing, is a step-by-step information resource for medical device manufacturers discussing and detailing the:

  • Definition of endotoxins;
  • Various tests used for their detection;
  • Use of depyrogenation and other ways to remove endotoxins;
  • Types of devices that should be tested;
  • Preparation and testing of samples;
  • Options for sampling containers;
  • Acceptance criteria for each of the assays; and
  • Sources of official information, reference, and guidance.

The Fundamentals of Endotoxin Testing” is authored by Steven Richter, Ph.D., said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — and a former FDA official.

Download the brief from: http://microtestlabs.com/endotoxin-testing.

The paper is one in a series about testing, manufacturing, and regulatory issues of concern for medical device manufacturers from Microtest Laboratories, a leader in testing services and contract manufacturing for medical devices, pharmaceuticals, and biotechnology.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for medical devices, pharmaceuticals, and biotechnology. It was founded in 1984. The company’s expertise and flexible processes enhance product safety and security, speed time to market, and minimize supply chain disruption. Microtest’s unique single-source capability to provide testing and manufacturing solutions allows the firm to support a full pharmaceutical or medical device product release. The company’s facilities in Agawam, Massachusetts, USA include state-of-the-art aseptic manufacturing areas; analytical chemistry, microbiological, and virological laboratories; Class 100 clean rooms; onsite steam and ethylene oxide sterilization, plus depyrogenation capabilities; purified water systems; and voice/data systems. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs on Facebook at http://goo.gl/TndoBg.

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Tuesday, December 3rd, 2013

Microtest Laboratories Offers OECD Fish Embryo Toxicity Testing

AGAWAM, MASS. — December 3, 2013 — Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries, is adding OECD Fish Embryo Toxicity Testing to its portfolio of services.

Pharmaceutical, chemical, and related manufacturing plants are under increased scrutiny for the potential impact of their products or waste water on the environment. Pesticides are a major example. But recently, the European Commission added three pharmaceutical compounds to its pollutant watch list, citing them as potential risk to the safety of surface water.

“Fish Embryo Toxicity (FET) testing has been developed for environmental and hazard classification applications. The test utilizes the embryo of the Zebrafish and exposes it to various compounds to observe potential toxic effects, thus making FET an ideal method to use in monitoring or investigating environmental cases,” said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — and former FDA official.

The FET test is an approved OECD (Organization for Economic Co-Operative Development) guideline, published in August, 2013.

““Microtest Laboratories is deeply experienced in fish embryo toxicity testing. We are particularly well-suited to undertake FET testing due to the expertise we’ve developed in creating our Zebrafish Embryo Toxicity (ZET) test, which we’ve been providing as a preliminary screening method in the biocompatibility testing of medical devices and polymers.

“Zebrafish embryos are extensively used in drug development studies due to their transparent embryos and fast development times. The Zebrafish is a well-studied and characterized organism, and ideal as an animal testing model,” Richter noted.

For more information about Microtest Laboratories’ FET testing services, visit http://www.microtestlabs.com/zebrafish-embryos-testing. Or, call 1-413-786-1680 or toll-free at 1-800-631-1680.

In addition, a new whitepaper provides an overview of FET testing. Download “Fish Embryo Toxicology Testing: The Better Alternative for Whole-Effluent Testing” from: http://microtestlabs.com/fish-embryo-toxicology-testing.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free at 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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Download high-resolution photos for publication from: http://flic.kr/s/aHsjNs2t58


Tuesday, November 19th, 2013

EH&E Named One of The Boston Globe’s Top Places to Work in 2013

Needham, MA — November 19, 2013 –– Environmental Health & Engineering, Inc. (EH&E), a leading provider of environmental and engineering consulting services to the property management, healthcare, research, and biopharma  industries, has been named one of The Boston Globe’s Top Places to Work for 2013.

The Boston Globe’s 2013 Top Places to Work survey recognizes the most progressive companies in Massachusetts, based on employees’ opinions of key factors related to employee happiness including leadership, appreciation, career opportunities, compensation, and management practices in their organizations. This year’s results are based on a survey of 76,000 employees.

“EH&E is an employee-owned company and our people drive the growth and success of our company,” says John McCarthy, President and co-founder of EH&E. “They are passionate about their work and committed to providing customers with exceptional service.  In our 25th year, it is rewarding that their enthusiasm has earned us the distinction of being one of the best places to work in Boston.

EH&E helps businesses and institutions optimize their work environment, environmental compliance programs and building performance to prevent disruptions to vital operations and to maximize alignment with business goals. EH&E has worked with distinguished national organizations and agencies including the US Environmental Protection Agency, Brigham and Women’s Hospital, Massachusetts Institute of Technology, Putnam Investments, Steward Health Care Network, The Broad Institute and Partners Healthcare. Our professional scientific and engineering staff provides expertise in over 80 technical disciplines, and includes internationally recognized experts in many scientific fields. EH&E brings innovative and sound scientific solutions to each business challenge our clients face. EH&E is based in Neeham, Mass. Visit our website at http://www.eheinc.com.


Tuesday, November 12th, 2013

Current Regulatory Expectations Affecting the Validation of Reusable Medical Devices is Subject of Dec. 4th Seminar in Boston

AGAWAM, MASS. — November 12, 2013 — A half-day seminar focusing on current regulatory expectations in the validation of reusable medical devices is the subject of a seminar set for Dec. 4th in Waltham, Mass., near Boston.

The validation of reusable medical devices is at the forefront of the FDA’s efforts to ensure patient safety. Requirements for the cleaning, disinfection, and sterilization of reusable devices are constantly changing. The situation challenges manufacturers both in terms of deciding which testing methods to employ as well as the planning of end points.

The seminar will provide attendees with the knowledge they need to know about current regulatory expectations so they may better prepare their submissions for FDA acceptance — and avoid the time-consuming and costly requirements of additional testing.

Seminar topics will include:

  • Discussion of the FDA’s draft guidance for industry and FDA staff, “Processing/ Preprocessing Medical Devices in Healthcare Settings”
  • Methods used for the cleaning and validation of reusable devices
  • Methods for the disinfection of reusable devices
  • Methods for the sterilization of reusable devices
  • Testing requirements
  • Detailed discussion of endpoints for cleaning validation

The seminar will be presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries, on Wednesday, Dec. 4, 2013, from 9 a.m. to 1 p.m. at the Conference Center at Waltham Woods in Waltham, Mass., just outside Boston. Registration is at 9 a.m. A continental breakfast, break refreshments, and a luncheon are included.

To register, visit http://goo.gl/DvaECn or contact Julie Adamski 1-800-631-1680, ext. 192, or jadamski@microtestlabs.com. Advance registration is $149.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Facebook at http://facebook.com/MicrotestLaboratories, on LinkedIn at http://goo.gl/H8ZLnM or on Twitter @MicrotestLabs.


Tuesday, November 5th, 2013

Outsourcing to a Contract Testing Laboratory is Focus of 2013 AAPS Expo Workshop

AGAWAM, MASS. – Nov. 5, 2013 – The strategies and timing of outsourcing pharmaceutical development processes to a contract testing laboratory will be the focus of a mini-workshop at the 2013 AAPS Annual Meeting and Exposition on Nov. 12, 2013.

“Outsourcing to a contract testing laboratory can save pharmaceutical manufacturers both time and money in drug development and commercialization. But knowing the appropriate time and place to outsource can mean the difference between success and failure,” said Shawn Sherry of Microtest Laboratories.

At the mini-workshop, titled “Outsourcing to a Contract Testing Laboratory, Sherry will overview:

  • The benefits of using turnkey contract laboratory services
  • How to establish a smooth working relationship with your laboratory
  • The importance of the auditing process
  • Quality system, timeline, and pricing factors
  • How Microtest Laboratories can help

The mini-workshop will be presented Nov. 12th from 2:00 p.m. to 2:15 p.m. in the Microtest Laboratories booth, #1325, at the AAPS 2013 Annual Exposition.

Shawn Sherry, Account Development Manager at Microtest Laboratories Inc., has over 11 years’ experience in regulatory microbiology and contract laboratory operations. Sherry holds a BS degree in microbiology and is a nationally registered microbiologist. His experience ranges from compendia testing requirements to aseptic manufacturing, with emphasis on disinfectant qualifications, clean room testing, product testing, and water system validations. He is the co-author of the whitepaper, “Disinfectant Qualifications: Insight and Perspective,” available at http://www.microtestlabs.com/disinfectant-qualifications.

Microtest Laboratories will exhibit in booth #1325 throughout the 2013 AAPS Annual Meeting and Exposition. Microtest Labs is a leader in pharmaceutical contract manufacturing as well as microbiological, analytical, and cleanroom testing services. The company services the pharmaceutical, medical device, and biotechnology industries. Based in Agawam, Mass., Microtest’s testing facilities are ISO 9001 and ISO 17025 certified, FDA regulated, and meet all GLP/GMP standards. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Tuesday, October 15th, 2013

Maryland Oncology Hematology Employs Medica’s EasyRA Clinical Chemistry Analyzer to Improve Lab Efficiency, Reduce Cost: Case Study

BEDFORD, Mass. — Oct. 15, 2013 — A case study details how Maryland Oncology Hematology is employing Medica’s EasyRA® Clinical Chemistry Analyzer to increase efficiency and reduce costs at its on-site clinical laboratory — while improving overall patient care.

[Download the case study from the Medica website at http://www.medicacorp.com/resources/easyra-clinical-chemistry-system.]

Maryland Oncology Hematology in Columbia, Md. is a full-service outpatient cancer treatment and testing facility. Visited by 80 to 100 patients a day, the practice provides a variety of cancer treatment therapies including chemotherapy, infusion therapy, injections, and therapeutic phlebotomies. The practice houses a state-accredited clinical laboratory that provides convenient and immediate testing results for patient convenience.

A routine yet essential service performed by many medical centers across the country, including Maryland Oncology Hematology, is the testing of blood samples. Lab technicians work with the patient and their doctor to administer and review blood test results to better guide treatment.

When Maryland Oncology Hematology moved to a new and larger facility, and established a new onsite clinical lab, the practice identified clinical chemistry as work that could be performed in-house. Lab Director Kendra Davies evaluated bench top clinical chemistry analyzers that would meet their four-person lab’s needs and which could be integrated with the lab’s workflow — without requiring additional staffing.

Based on interviews with Davies, the case study reviews how Maryland Oncology Hematology selected and now employs Medica Corporation’s EasyRA chemistry analyzer to realize greater laboratory efficiency and coordination of patient tests, while reducing overall cost. From shorter turnaround time to improved patient care, the case details how the EasyRA chemistry analyzer transformed the way Maryland Oncology Hematology conducted its day-to-day lab Chemistry workload.

Download the case study from the Medica website at http://www.medicacorp.com/resources/easyra-clinical-chemistry-system.

About Medica Corporation

Medica Corporation is a leading provider of easy-to-use, easy-to-maintain, low-cost blood testing analyzers. Based in Bedford, Massachusetts, U.S.A., the company is focused on the global need to reduce the cost and improve the quality of health care. Medica’s products include the EasyLyte®, ISE Module, EasyBloodGas™, EasyElectrolytes™, EasyStat®, EasyRA® and EasyCell® assistant analyzers. For more information, visit http://www.medicacorp.com.

The Medica logo and EasyRA® are registered trademarks of Medica Corporation or its subsidiaries and affiliated companies. All other brands may be trademarks of their respective holders.


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