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Press release news from the public relations clients of Tiziani Whitmyre, Inc.

Posts Tagged ‘pharmaceutical testing’


Tuesday, January 10th, 2012

Microtest Laboratories Will Manufacture ImmusanT’s Nexvax2 Immunotherapeutic Vaccine for Expected Clinical Trial

AGAWAM, MASS. – January 10, 2012Microtest Laboratories has announced that the company will manufacture and provide supporting pharmaceutical testing services for ImmusanT, Inc.’s Nexvax2® immunotherapeutic vaccine for its expected upcoming clinical trial.

 In addition to manufacturing Nexvax2, Microtest will provide a full range of testing services to ImmusanT supporting its drug product manufacture, including method transfer activities, complete final product release testing, storage and stability.

ImmusanT recently raised $20 million in financing to advance the development of their technology, Nexvax2, for the treatment of celiac disease. Celiac disease is an inherited autoimmune disorder that is triggered by the consumption of foods containing gluten causing an immune response resulting in inflammation of the small intestine. Safety, tolerability and bioactivity of Nexvax2 have been established in a Phase 1 clinical study.

“As a one-stop source of on-site pharmaceutical testing and manufacturing services, Microtest provides a fast, efficient, cost-effective — and risk-minimizing — alternative to subcontracting with a variety of providers at multiple locations,” said Alex Mello, Director of Project Management, Microtest Laboratories. “We deliver the flexibility, solutions, and problem-solving experience manufacturers must have to ensure the most expeditious release of their product.”

Microtest Laboratories provides flexible, customizable aseptic processing and fill/finish services – and a full-range of pharmaceutical testing services – for biotechnology and pharmaceutical companies of all sizes conducting Phase 1, 2, or 3 clinical trials. Microtest fill/finish operations comply with U.S. FDA and European EMA guidelines. Microtest has been inspected by the U.S. FDA, U.S. DEA, and Qualified Persons (QP) for both the manufacture and release testing of final drug product.

For more information, contact Alex Mello, Director of Project Management, at 1-800-631-1680, extension 121. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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.

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Press Contact: Don Goncalves, Tiziani Whitmyre public relations, 781-793-9380, dgoncalves@tizinc.com


Monday, January 12th, 2009

Free White Papers Detail Sterility Testing Essentials for Medical Device, Pharmaceutical Manufacturers

AGAWAM, MASS. – January 12, 2009 – Two new white papers detailing sterility testing essentials are now available for free download from Microtest (www.microtestlabs.com). The white papers, one which is customized for medical device manufacturers and one which is specialized for pharmaceutical manufacturers, presents the general concepts and problems associated with sterility testing and reviews different testing methodologies.

For medical device manufacturers, sterility testing of medical devices is required during the sterilization process as well as for routine quality control. Understanding sterility testing is essential when designing the validation process. The need to provide adequate and reliable test data is an important quality control issue. False positive results and test failures can have significant impact on production schedules and device time-to market. Medical device manufacturers can download the white paper at: http://www.microtestlabs.com/sterilitypaper/sterility-paper.htm.

For pharmaceutical manufacturers, sterility testing of pharmaceutical articles is an essential element of the sterilization validation process as well as for routine release testing. USP requirements employ sterility testing as an official test to determine suitability of a lot. Understanding sterility testing is beneficial in terms of designing a validation process. In addition, the need to provide adequate and reliable test data is an important quality assurance issue. Pharmaceutical manufacturers can download the white paper at: www.microtestlabs.com/sterilitypaper/pharma-paper.htm.

The author of the white papers is Steven Richter, Ph.D., President and Scientific Founder of Microtest, a leading provider of medical device and pharmaceutical services for medical device designers and manufacturers. The firm recently expanded its facilities, resources, and technology, and with more than 15 years of experience, is a single-source manufacturing solution.

For information on Microtest’s unique single-source solutions that minimize schedule disruptions and accelerate time to revenue visit Microtest on the Web: www.microtestlabs.com or toll-free: 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, 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 www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc. (http://www.tizinc.com/)


Tuesday, October 28th, 2008

“Biosafety Testing of Cell Lines Used in Vaccine and Virus Vector Production” is Focus of Presentation at WilBio Viral Vectors and Vaccines Conference

AGAWAM, MASS. – October 28, 2008 — Merribeth Morin, PhD, of Microtest Laboratories will present “Biosafety Testing of Cell Lines used in Vaccine and Virus Vector Production” at the WilBio Viral Vectors and Vaccines conference for Pandemic Viruses, Cancer Vaccines, and Gene Therapy, at 11:15 am-Noon, on Tuesday, Nov. 4, 2008 in Santa Barbara, Calif.

Dr. Morin’s presentation will discuss the safety concerns for the use of cell lines, in reference to their use in vaccine and vector production.

“The use of cell lines for the production of virus vectors and vaccines is widely applied. The ability to manipulate cells in culture and grow them to large scale is advantageous, and in the case of vaccines, presents a more attractive and consistent process than some more traditional methods for vaccine products. As for any type of biological product, using cell lines presents various safety considerations. There are a number of regulatory guidance documents that address the characterization of cells used for the production of biological products. The safety program for cell lines needs to be reasonable, but thorough, to address the safety concerns outlined in these documents,” said Dr. Morin.

Dr. Morin is Director of Virology for Microtest Laboratories, (http://www.microtestlabs.com/), a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. She received her PhD in Virology from Harvard University and has spent a number of years in both in vaccine research and in contract testing. Her research included developing DNA vaccines for the treatment of influenza virus infection and other infectious diseases, and the development of an attenuated vaccine for Herpes simplex virus infection.

Based in Agawam, Mass., Microtest’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.

The Viral Vectors and Vaccines Conference for Pandemic Viruses, Cancer Vaccines, and Gene Therapy runs Nov. 3-5, 2008. For more information, visit http://www.wilbio.com/.

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Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/


Friday, October 3rd, 2008

Microtest Honored as Regional Example of Success; Receives Hampden Achievement Award, Induction into STCC Western Mass. Entrepreneurship Hall of Fame

Agawam, Mass., October 3, 2008 – In recognition of the company’s growth, success, and importance to the region, Microtest Laboratories of Agawam has received the Hampden County Achievement Award and has been inducted to Springfield Technical Community College’s Western Massachusetts Entrepreneurship Hall of Fame.

“The achievements of Microtest Laboratories’ growth and success serve as a powerful model for the future of Massachusetts, and Microtest will serve as an inspiration to thousands of people who visit every year,” said Dr. Andrew M. Scibelli, President of Springfield Technical Community College (STCC).

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries and has made numerous multi-million capital investments and expansions of its facilities the past several years – along with growing its professional workforce to more than 100. The company works closely with Western Mass. economic and business organizations as well as the region’s educational institutions.

Microtest President and Scientific Founder Steven Richter, Ph. D., is an ardent supporter of regional technical training programs as a means to ready both current and future workers to contribute to – and reap the benefits of – the area’s burgeoning life science industry.

“It is an honor for all of us at Microtest to be recognized for our achievements,” said Richter. “If we can serve a role for others, then let it be as a example of the potential that’s available throughout Western Mass. when working partnerships among our entrepreneurs, education, residents, and government are permitted – and encouraged – for the benefit of all.”

The Andrew Scibelli Enterprise Center is committed to furthering regional economic development, entrepreneurship education and workforce development. It is home to the Western Massachusetts Entrepreneurship Hall of Fame. Established in 2000, it honors innovative entrepreneurial individuals and businesses in Western Massachusetts, in hope to inspire the next generation of business leaders.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, 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 www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/


Monday, November 26th, 2007

Microtest Expands Medical Device Laboratory, Package Validation, Pharma Fill/Finish Services

Agawam, Mass., November 20, 2007 – Microtest, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries, is once again expanding its high tech facilities and wide range of services at its Agawam, Massachusetts headquarters.

Microtest today announced that it has doubled the size of its medical device/pharmaceutical stability storage capabilities, as well as significantly expanded its medical device packaging laboratory and its GMP pharma fill/finish contract manufacturing services.

The announcement follows the company’s completion last year of a $7.5 million capital improvement and expansion project that added new state-of-the art pharmaceutical testing laboratories and new aseptic fill/finish manufacturing facilities – along with new professional staff.

“We are continuing to enjoy strong growth throughout all areas of our business,” said Steve Richter, Ph.D., Microtest President and Scientific Director, and “we’re continuing to invest our resources so that we may best serve our existing and future clients.”

“Package validation is needed to support our medical device clients. We’re also dedicating additional new space to our growing product stability testing laboratories as well as our GMP drug manufacturing services,” said Richter. “As a growing provider of fill/finish operations, we have all the systems and procedures in place to fully support all the requirements of the FDA, EMEA and any drug-regulating body in the world.”

In October, Microtest was honored by the Massachusetts Economic Impact Award for its strong record of job creation and business expansion.

To contact Microtest, visit www.microtestlabs.com or call toll-free: 1-800-631-
1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, 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 www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc., www.tizinc.com


Monday, October 15th, 2007

Microtest Labs of Agawam Wins Massachusetts Economic Impact Award

Agawam, Mass., October 15, 2007 – Microtest Laboratories (www.microtestlabs.com) of Agawam has been honored with a Massachusetts Economic Impact Award for its strong record of job creation and business expansion.

The company was named the Silver Level award recipient in the western Mass. region by the Massachusetts Alliance for Economic Development (MAED).

“To be recognized as an economic leader in western Mass. is a huge honor for us,“ said Steven Richter, Ph. D., President and Scientific Founder of Microtest. “The success of our region is very important to Microtest, our employees, business partners and education partners, especially as we strive to expand the state’s presence of life sciences and biotechnology companies throughout western Mass.”

Microtest, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries, employs more than 100 in Agawam. The company recently completed a $7.5 million expansion to its headquarters, adding new state-of-the art pharmaceutical testing laboratories and new aseptic fill/finish manufacturing facilities – along with new professional staff.

The company has working partnerships with economic and business organizations throughout Western Mass. – and deep relationships with the region’s educational institutions.

MAED is a private, non-profit partnership of business, industry leaders, and government dedicated to the economic growth of Massachusetts. MAED will recognize its 2007 Team Massachusetts Economic Impact Award winners during a special luncheon on November 20, 2007. For more information, visit http://www.massecon.com.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, 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 www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc. (http://www.tizinc.com)


Monday, September 17th, 2007

Microtest Labs of Agawam Is Finalist for Mass. Alliance For Economic Development’s Team Massachusetts Economic Impact Award

Agawam, Mass., Sept. 17, 2007 – Microtest Laboratories of Agawam has been named as a finalist for the 2007 Team Massachusetts Economic Impact Award by the Massachusetts Alliance For Economic Development (MAED).

The Awards honor the companies that have made the strongest contributions over the past year to the Massachusetts economy through job creation and business expansion. Microtest is being considered for its impact and contributions in Western Mass.

Microtest, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries, employs more than 100 in Agawam. The company recently completed a $7.5 million expansion to its headquarters, adding new state-of-the art pharmaceutical testing laboratories and new aseptic fill/finish manufacturing facilities – along with new professional staff.

The company has working partnerships with economic and business organizations throughout Western Mass. – and deep relationships with the region’s educational institutions.

“Everyone at Microtest is extremely proud” of being named a finalist by MAED, said Steven Richter, Ph. D., President and Scientific Founder of Microtest. “Our mission is to become a long term economic driver in the valley.”

“Being named as a Finalist is more than an honor. I’m always telling everyone – in and out of state – that the exciting growth and success we’re enjoying at Microtest today is directly due to the contributions of our employees, and the educational, state and local support and resources of Massachusetts,” Richter said.

MAED is a private, non-profit partnership of business, industry leaders, and government dedicated to the economic growth of Massachusetts. MAED will announce its 2007 Team Massachusetts Economic Impact Award winners during a special luncheon on November 20, 2007. For more information, visit http://www.massecon.com.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, 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.

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Public Relations contact: Tiziani Whitmyre Inc. (www.tizinc.com)


Wednesday, September 12th, 2007

Free White Papers Detail Sterility Testing Essentials for Medical Device, Pharmaceutical Manufacturers

AGAWAM, MASS. – September 12, 2007 – Two new white papers detailing sterility testing essentials are now available for free download from Microtest (http://www.microtestlabs.com/).
The white papers, one which is customized for medical device manufacturers and one which is specialized for pharmaceutical manufacturers, presents the general concepts and problems associated with sterility testing and reviews different testing methodologies.

For medical device manufacturers, sterility testing of medical devices is required during the sterilization process as well as for routine quality control. Understanding sterility testing is essential when designing the validation process. The need to provide adequate and reliable test data is an important quality control issue. False positive results and test failures can have significant impact on production schedules and device time-to market. Medical device manufacturers can download the white paper at: http://www.microtestlabs.com/sterilitypaper/sterility-paper.htm.

Microtest Sterility White Paper Pharma For pharmaceutical manufacturers, sterility testing of pharmaceutical articles is an essential element of the sterilization validation process as well as for routine release testing. USP requirements employ sterility testing as an official test to determine suitability of a lot. Understanding sterility testing is beneficial in terms of designing a validation process. In addition, the need to provide adequate and reliable test data is an important quality assurance issue. Pharmaceutical manufacturers can download the white paper at: www.microtestlabs.com/sterilitypaper/pharma-paper.htm.

The author of the white papers is Steven Richter, Ph.D., President and Scientific Founder of Microtest, a leading provider of medical device and pharmaceutical services for medical device designers and manufacturers. The firm recently expanded its facilities, resources, and technology, and with more than 15 years of experience, is a single-source manufacturing solution.

For information on Microtest’s unique single-source solutions that minimize schedule disruptions and accelerate time to revenue, visit Microtest on the Web: www.microtestlabs.com or toll-free: 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, 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 www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc. (http://www.tizinc.com/)


Monday, July 9th, 2007

New, Free White Paper Details Compliance Requirements for Pharmaceutical, Medical Device Manufacturers

AGAWAM, MASS. – July 9, 2007 – A new, free white paper, detailing critical industrial sterilization and contamination control programs and compliance challenges in the pharmaceutical and medical device manufacturing industries is now available for download at www.microtestlabs.com/environmentpaper.

One of the biggest challenges faced by medical device manufacturers is determining exactly what is required for compliance. For parenteral manufacturers, the environmental control parameters are highly stringent and pose significant compliance challenges.

In the white paper, titled “Environmental Testing & Monitoring: Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers,” Microtest Project Manager Scott Mackin, reviews key elements of a best practice environmental testing program, including sterilization standards, FDA compliance requirements and vital factors in maintaining controlled environments.

At Microtest (http://www.microtestlabs.com/), Mackin has assisted a number of medical device manufacturers in designing, implementing, and maintaining both sterilization and environmental monitoring programs.

Microtest, a full service testing services and contract manufacturer, offers a complete range of onsite and remote monitoring programs for specialized environmental testing services. Microtest experts utilize cutting edge technology and processes to determine viable microbial and nonviable particulate levels of any area used for medical device and pharmaceutical cleanroom or manufacturing purposes.

Download the free white paper, “Environmental Testing & Monitoring: Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers,” at: www.microtestlabs.com/environmentpaper. Or, for more information, visit Microtest on the Web at www.microtestlabs.com, or call toll-free: 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, 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.

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Press release contact: Tiziani Whitmyre, http://www.tizinc.com


Tuesday, May 1st, 2007

Microtest to Highlight Virology and Pharmaceutical Testing, Contract Manufacturing Capabilities at Bio International Convention

AGAWAM, MASS. – May 1, 2007 – Microtest Laboratories (http://www.microtestlabs.com/) will highlight its expanded contract manufacturing, virology, and pharmaceutical testing capabilities at the BIO International Convention, May 6-9 at the Boston Convention & Exhibition Center.

With its completion of a $7.5 million capital improvement program, Microtest has added a new state-of-the-art pharmaceutical testing laboratory, a series of segregated virology testing laboratories, new aseptic fill/finish manufacturing facilities, and purchased a MicroSeq® Microbial Identification System – along with the hiring of additional professional staff.

With this addition, Microtest has bolstered its services and emerged as a leader in the contract manufacturing market.

“As a customer-focused provider of both contract laboratory testing and contract manufacturing services, we offer unique cross-over benefits for our customers,” said Steve Richter, PH. D., Microtest President. “These include a complete range of pharmaceutical and virology test services that can support full in-process and product release testing as well as product stability testing, raw material qualification, and assay development/validation,” added Richter.

“Moreover, since we manufacture the pharmaceutical product – as a growing provider of fill/finish operations –we have all the systems and procedures in place to fully support all the requirements of the FDA, EMEA and any drug-regulating body in the world,” Richter noted.

For more information on Microtest capabilities and services, visit Richter in the Microtest booth, number 533/A20, at the BIO International Convention, May 6-9 in the Boston Convention & Exhibition Center in Boston.

Or, visit the Microtest website at www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption.

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Press release contact: Tizinani Whitmyre, www.tizinc.com


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