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Tuesday, January 10th, 2012

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

AGAWAM, MASS. – January 10, 2012 – Microtest 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, visit the Microtest website at: http://www.microtestlabs.com/aseptic-processing/fill-finish/ or 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

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Posted in Biosciences |


Tuesday, October 18th, 2011

Immunetics, Inc. to Present Novel, Rapid Test for Bacterial Contamination of Platelets at American Association of Blood Banks (AABB) Annual Meeting

Boston, Mass. — October 18, 2011 — Immunetics, Inc. announced plans to present a novel, rapid test for bacterial contamination of platelets at the American Association of Blood Banks (AABB) Annual Meeting, Oct. 21st-25th, in San Diego.

Bacterial contamination of platelets has been identified as the #1 infectious risk of transfusion, with approximately 1 out of 2,000 platelet units contaminated. Transfusion of bacterially contaminated platelets poses a significant health risk, potentially resulting in serious to fatal illness in the recipient. Traditional methods for detecting bacteria are based on inoculation of platelet samples into culture bottles followed by a 24-72 hour waiting period. In addition to the lengthy incubation period, recent studies have shown these methods to be prone to both false positive and false negative results. Culture testing has been routine for single donor platelets but is not practical for pooled whole blood-derived platelets, which must be used within 4 hours of pooling. About five million platelet units are collected annually in the United States along with an equal number in other countries.

Immunetics’ BacTx® rapid test can detect bacterial contamination by clinically relevant species in less than one hour, at levels below those shown to be harmful to transfusion recipients.

Multi-center clinical trials have been concluded in which the performance of the BacTx test was evaluated on whole blood-derived random-donor platelet units.

The results of these studies, and implications for other studies, will be presented and discussed by two clinical investigators at the AABB Meeting in a breakfast workshop entitled “BacTx – A Novel Method for the Detection of Bacteria in Platelets,” on Monday, Oct. 24, 2011, at 7:00-8:15 a.m., in Room 29 C/D in the San Diego Convention Center. The presenters are: W. Andrew Heaton, M.D., Sr. Director of Transfusion Medicine, NSLIJ Health System and Michael R. Jacobs, M.D., Ph.D., Director, Clinical Microbiology, University Hospitals, Case Medical Center. The BacTx test is currently under pre-market review by the FDA.

For more information, contact Immunetics (http://www.immunetics.com) at 617-896-9100 or 800-227-4765, or visit Immunetics at booth # 643 at the AABB Annual Meeting.

About Immunetics

Immunetics Inc. (http://www.immunetics.com) offers state-of-the-art assay technology for infectious disease diagnosis and blood screening, and for more than ten years has been a leading innovator of tests for bacterial, viral, and parasitic diseases. The company produces and markets a range of infectious disease assay kits and instruments. Its mission is to deliver better, cost-efficient care through more accurate diagnosis. Immunetics is headquartered in Boston. Follow Immunetics on Twitter at http://twitter.com/immunetics.

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

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Posted in Biosciences, Health/Medical |


Tuesday, September 27th, 2011

New White Paper for Dietary Supplement Manufacturers Provides How-to for New FDA Compliance Paradigm

Critical information that dietary supplement manufacturers must know in order to meet the Federal Food & Drug Administration’s (FDA) good manufacturing practices “compliance paradigm” is detailed in a free white paper available at http://www.microtestlabs.com/dietarypaper.

The white paper, “Dietary Supplements — A New Paradigm for Manufacturers,” provides how-to guidance for manufacturers of dietary supplements – a fast-growing market, which totaled $23 billion and more than 40,000 products in 2008.

Just 15 years ago, the production of dietary supplements was regulated as food ingredients without oversight. Today, the FDA regulates their manufacture under the current Good Manufacturing Practices (cGMP) for Dietary Supplements, listed in 21 Code of Federal Regulations (CFR) 111.

“Today, there’s a new paradigm for dietary supplement manufacturers – and it’s one of testing, manufacturing, and lot release. cGMP controls are used to assure that products meet the requirements of safety and have the strength and identity to meet the label claims.  And label claims are the driver for all FDA regulatory actions,” said Steven G. Richter, Ph.D., RAC, SM (NRM), author of the white paper, and President and Chief Scientific Officer of Microtest Laboratories.

“In fact, this new ‘compliance paradigm’ dietary supplement manufacturers is very similar to pharmaceutical manufacturing. The problem is that, for many small- and medium-sized companies which produce dietary supplements, compliance with the spirit and intent of the cGMPs is proving to be a challenge,” he said.

For those manufacturers, the white paper provides a much needed overview and discussion of what’s required of the by the FDA, including how-to guidance on:

  • Developing the Necessary Quality System
  • Management “Buy In”
  • Microbiological Testing/Practices In The USP Dietary Supplement Compendium and FDA BAM
  • Chemistry and Manufacturing Controls (CMC)

The white paper is available at: http://www.microtestlabs.com/dietarypaper.

“The challenges for small and medium sized manufacturers are these: Testing dietary supplements and determining compliance requires the personnel and facilities to handle large-scale testing programs. The ability to train and retain these employees may be a challenge. And a full cGMP assessment is required for each manufacturer.

“Compliance with the intent of the law will be determined by management’s buy-in to a robust quality program with concomitant lab support,” Richter said. “Given all this, for many small and medium sized manufacturers, outsourcing the majority of their testing may make most economical sense.”

For a full discussion of the issues surrounding the FDA’s Good Manufacturing Practices (cGMP) for Dietary Supplements, download the new, free white paper, “Dietary Supplements — A New Paradigm for Manufacturers,” from http://www.microtestlabs.com/dietarypaper.

For more information, visit http://www.microtestlabs.com. Follow Microtest Labs on Twitter@MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest

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, visithttp://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Posted in Biosciences, Health/Medical, Life Sciences |


Wednesday, September 21st, 2011

Building, Validating & Maintaining Controlled Environment Facilities is Focus of Oct. 18th Seminar in Boston Hosted by Microtest Laboratories

AGAWAM, Mass. — Building, validating, and maintaining a controlled environment facility is the subject of a daylong seminar on Oct. 18, 2011, hosted by Microtest Laboratories at the MIT Endicott House in Dedham, Massachusetts.

Titled “Keeping It Clean? The Building Blocks of Facility Control,” the seminar will focus on the clean room testing, disinfection validation, and related contamination testing issues that arise from manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.

In each seminar program, industry experts will present practice advice and sound solutions in an interactive format that will encourage a high level of engagement by participants for questions, answers and discussion. The topics will include:

  • Killing The Bugs Without Killing Yourself: Disinfectant Qualifications
  • Feeling Like A Fish Out of WFI?: Water System Validation and Maintenance
  • Got A Lot On Your Plate: Clean-room Validations and Maintenance
  • The Old In & Out: Considerations On Insourcing vs. Outsourcing

“Keeping It Clean? The Building Blocks of Facility Control” will be presented 8:30 a.m. to 3:30 p.m. on Tuesday, Oct. 18, 2011, at the MIT Endicott House, 80 Haven Street in Dedham, Mass., just outside of Boston. Registration and a complimentary continental breakfast is at 8 a.m. Lunch will be served at Noon. The cost is $149 per person and includes meals, refreshments, and workshop handouts.

To register or for more information, visit the Microtest Laboratories website at http://www.microtestlabs.com/seminar/index.asp. Or, contact Julie Adamski at 413-786-1680, toll-free at 1-800-631-1680, or at jadamski@microtestlabs.com.

About Microtest Laboratories

Microtest Laboratories is a leader in controlled environment facility testing, laboratory testing, and contract manufacturing 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 Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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

 

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Posted in Biosciences, Health/Medical, Uncategorized |


Wednesday, August 24th, 2011

New White Paper Examines Clinical Trial Material Production & Testing: What Your Contract Manufacturing Organization is Not Telling You

AGAWAM, Mass., Aug. 24, 2011 — For pharmaceutical manufacturers, delays in starting a clinical trial program due to issues involving the manufacture of clinical trial material (CTM) and the associated fill/finish and release work can make even the most dogged project managers wince in pain. A new, free white paper recommends a proven process of evaluating a cGMP contract manufacturing organization (CMO) to deliver all the required processes needed to release CTM for clinical trial use.

The new white paper, “Clinical Trial Material Production and Testing: Is Your CMO Providing Everything You Need,” explores what pharmaceutical manufacturers must require from a CMO in terms of capabilities and expertise and the critical roles that the contractor must be able to assume in the clinical trial material manufacturing process.

The white paper is available for download from: http://www.microtestlabs.com/clinical-trial-material-production-testing-paper/.

“In order to keep clinical protocols on time and on budget in the CTM manufacturing process, it’s critical that the selected CMO has comprehensive capabilities that are both in-house and readily available,” notes Alexander Mello, author of the white paper and Director of Project Management, Manufacturing, for Microtest Laboratories, a leader in contract manufacturing, aseptic processing and full service pharmaceutical testing.

“Contracting with a CMO without complete in-house expertise will add unnecessary time to the CTM process. In these cases, performing a GMP audit of the CMO, plus all of the other companies (formulators, laboratories, labelers, etc.) that the CMO uses in the supply chain, will add significantly to the overall cost and time for the technical transfer of the product,” he explains.

The new white paper illustrates how the proper selection of a CMO can help meet product schedules and minimize potential restart activities. The paper reviews the roles that the CMO must be able to play in CTM process, from first steps through the completion, and details the key areas of Raw Materials, Formulation, and Final Drug Product (FDP).

The white paper also discusses how a fully-capable CMO will have the ability to perform all the required processes in CTM – including excipient and API release for GMP manufacture, formulation, in-process testing, environmental monitoring, filter integrity testing, and final release testing.

To download the new, free white paper, “Clinical Trial Material Production and Testing: Is Your CMO Providing Everything You Need,” visit http://www.microtestlabs.com/clinical-trial-material-production-testing-paper/.

Mello, the author of the white paper, is Director of Project Management, Manufacturing, for Microtest Laboratories. Mello’s 15 years of experience span Aseptic Fill/Finish, Microbiology, Method Transfer, Stability of Drug Product, Medical Devices/Combo Devices, and Sterilization Sciences. He holds a graduate degree in Biological Sciences and is a Specialist Microbiologist (NRM).

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest

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, visithttp://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Posted in Biosciences, Manufacturing |


Wednesday, July 6th, 2011

Microtest Laboratories Announces New Fast-Track Toxicity Testing for Medical Devices Using Zebrafish Embryos

AGAWAM, MASS. - July 6, 2011 - Microtest Laboratories has announced a new fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos (Danio rerio), a technique already widely utilized in drug development studies.

zebrafish“Testing has revealed that Zebrafish embryos are highly susceptible to toxins. In fact, Zebrafish labs are ubiquitous in most universities and research hospitals,” said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories, and former U.S. Food & Drug Administration (FDA) official.

“We’ve confirmed the application of Zebrafish embryos in the toxicity testing of materials used in medical devices,” Dr. Richter said. “With our in-vitro test, manufacturers and bio materials researchers can screen thousands of polymers in less than a week – yielding significant economic savings in both the time and expense of medical device testing.”

In its research, Microtest Laboratories found that the current “gold standard” USP Cytotoxicity Assay, which utilizes live mouse fibroblasts (L929) cells in culture, failed to detect the toxicity of a BPA extract during testing – while Microtest’s new Zebrafish embryo screen succeeded.

BPA (bis-phenol A) is a suspected toxic polymer assumed as having both carcinogenic and teratogenic effects on humans. The U.S. Environmental Protection Agency (EPA) has indicated that BPA will be slated for screening soon.

“Microtest’s new Zebrafish embryo assay has better sensitivity and generates more scientific data than the small animal tests currently recommended by the FDA,” Dr. Richter said.

“The use of Zebrafish embryos will reduce or eliminate the current animal testing required for all medical devices testing. This important vertebrate model has demonstrated similarities to mammalian models and humans in toxicity testing,” he noted.

Microtest Laboratories’ new Zebrafish embryo assay for the toxicity testing of medical devices is immediately available. For more information, visit http://www.microtestlabs.com/zebrafish-embryos-testing or call 1-413-786-1680 or toll-free 1-800-631-1680

About Microtest Laboratories

Microtest Laboratories is a leader in medical device testing and related services for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., 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 Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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

Download high resolution image from: http://www.microtestlabs.com/photos

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Posted in Biosciences, Health/Medical, Life Sciences |


Tuesday, May 31st, 2011

Immunetics Receives $500,000 from Massachusetts Life Sciences Center to Commercialize BacTx® Test for Bacterial Contamination in Platelet Transfusions

Immunetics, Inc., today announced it has been awarded a $500,000 Massachusetts Life Sciences Center Small Business Matching Grant (SBMG) to commercialize its BacTx® rapid test for detecting bacterial contamination in platelets.

Platelets are a vital blood product enabling clotting, and patients suffering from trauma, surgical procedures, cancer, or chemotherapy must receive platelet transfusions to survive. Bacterial contamination of platelets is the leading cause of infection during transfusion, with patients facing the risk of severe or fatal transfusion-associated sepsis from the roughly 1 in 2,000 platelet units that are contaminated.

“Rapidly detecting bacteria in platelet units presents a major challenge. Some current testing methods are ineffective because of low sensitivity. Others are overly difficult or time-consuming to perform close to transfusion,” said Dr. Andrew Levin, president and scientific director, Immunetics.

“According to the American Association of Blood Banks (AABB), a rapid test with high sensitivity performed close to the time of transfusion would represent a breakthrough in transfusion safety. The Massachusetts Life Sciences Center grant will help us transition the critical juncture from R&D to manufacturing scale-up and regulatory approval — and commercially launch BacTx,” Levin said.

Immunetics has concluded clinical trials for BacTx® and plans to submit an application for approval to the U.S. Food and Drug Administration (FDA) this summer. With FDA approval, BacTx® could be launched as early as this year.

Immunetics was one of four life sciences firms named by the Massachusetts Life Sciences Center’s Board of Directors (“the Center”) to share in $2 million in new SBMGs. The four recipients were chosen through a competitive process after extensive review by the Center’s peer review panel, Scientific Advisory Board, and Board of Directors. The grants foster job growth and technology commercialization in the Massachusetts Life Sciences Supercluster.

“Helping our life sciences companies grow is all about creating jobs,” said Governor Deval Patrick. “As we continue to strengthen our global leadership in the life sciences, the Center’s Small Business Matching Grant Program is meeting an important need and making Massachusetts an even more attractive place for life sciences companies to locate and grow.”

“The SBMG program is another example of the Center’s leveraging strategy,” said Dr. Susan Windham-Bannister, President and CEO of the Massachusetts Life Sciences Center. “Federal SBIR/STTR grants provide Massachusetts companies with funds for their research and development; our SBMG program then provides the funds that companies need to bridge to commercialization. These four promising companies will bring cost-effective new treatments to the market and expand employment opportunities in Massachusetts. We are especially pleased that some of our grantees will contribute directly to the creation of biomanufacturing jobs in the Commonwealth.”

“As an author of the legislation creating the Life Sciences Center several years ago, I am excited about the wonderful opportunity to grow the Life Sciences industry on the South Boston Waterfront,” said State Senator Jack Hart (D-South Boston).

“Immunetics is doing important work to prevent infectious disease and improve public health in our state and around the world,” said State Representative Nick Collins (D-South Boston), a member of the Joint Committee on Economic Development and Emerging Technologies. “This award by the Massachusetts Life Sciences Center is an example of the Commonwealth’s commitment to investing in our state’s economic future. It is also another sign of the continued emergence of the South Boston Waterfront as a center for innovation and job creation in the life sciences industry.”

“I am extremely grateful for the continuing support by the Commonwealth and the Massachusetts Life Sciences Center of our mission to introduce innovations in the diagnosis of infectious diseases, as we grow our company in South Boston and become a stronger part of — and employer in — the very exciting Massachusetts Life Sciences community,” Levin said.

Immunetics received two SBIR Phase II grants totaling approximately $4 million from the National Heart, Lung, and Blood Institute (NHLBI), an agency of the National Institutes of Health (NIH), which supported the research and development of the test. The technology underlying the test is protected by a recently issued U.S. patent, and foreign patents with approved claims are in process of issue.

With FDA approval, the BacTx® test will be marketed to blood centers and hospitals throughout the U.S. and around the world. In total, about 5 million platelet units are collected annually in the U.S. and an equal number outside the U.S.

About Immunetics, Inc.

Immunetics Inc. (http://www.immunetics.com), offers state-of-the-art assay technology for infectious disease diagnosis and pathogen detection, and for over 10 years has been a leading innovator of tests for bacterial, viral, and parasitic diseases. The company produces and markets a range of infectious disease assay kits and instruments. Its mission is to deliver better, cost-efficient care through more accurate diagnosis. Immunetics is headquartered in Boston, Mass. Follow Immunetics on Twitter at http://twitter.com/immunetics.

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

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Posted in Biosciences, Health/Medical |


Tuesday, May 3rd, 2011

Immunetics Awarded $2.4 Million NIH Grant for Clinical Trials of New Blood Test for Chagas’ Disease

immunetics-release-logoBOSTON – May 3, 2011 – Immunetics, Inc. today announced it has been awarded a $2.4 million, 3-year Phase II SBIR grant by the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health (NIH), to support clinical trials of the company’s new confirmatory test for Chagas’ disease, a serious and potentially fatal parasitic infection.

Chagas’ disease is endemic in large parts of Latin America, where it affects up to 11 million people, and has emerged in the U.S., where more than 300,000 people are infected, according to the Centers for Disease Control and Prevention. The disease is difficult to diagnose, and is often silent for years before clinical symptoms appear. During this time, carriers can pass on the parasite through blood donations and infect transfusion recipients.

Existing screening tests that detect antibodies to the parasite are frequently inaccurate. A complex method called radioimmunoprecipitation (RIPA) is sometimes used to confirm screening test results, but is beyond the reach of most laboratories. There are no FDA-approved confirmatory test methods.

Immunetics’ test, called an immunoblot, detects antibodies to the parasite and is based on the same technology used in confirmatory tests for HIV and several other bloodborne infections. Data presented by Immunetics at meetings in 2010 of the American Association of Blood Banks and the American Society of Tropical Medicine and Hygiene showed the immunoblot test to be as accurate as RIPA in preliminary studies, said Dr. Andrew Levin, president and scientific director, Immunetics.

“The new NIH grant will enable Immunetics to undertake a full-scale clinical trial to obtain data to submit to the FDA for approval of the immunoblot as a confirmatory test. Immunetics will undertake the studies with collaborators at Blood Systems Research Institute, the American Red Cross, and the Centers for Disease Control and Prevention,” Levin said.

“This grant award gives us the opportunity to take our Chagas’ immunoblot test through the clinical studies needed to establish its validity as a confirmatory test. We are very grateful for NIH support for this project, which will allow us to bring forward a practical solution to one part of the growing public health and blood safety problem that Chagas’ disease presents in the U.S. and Latin America,” he said.

About Immunetics, Inc.

Immunetics Inc., (http://www.immunetics.com) offers state-of-the-art assay technology for infectious disease diagnosis and pathogen detection, and for over 10 years has been a leading innovator of tests for bacterial, viral, and parasitic diseases. The company produces and markets a range of infectious disease assay kits and instruments. Its mission is better, cost-efficient care through more accurate diagnosis. Immunetics is headquartered in Boston, Mass. Follow Immunetics on Twitter at http://twitter.com/immunetics.

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

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Posted in Biosciences, Life Sciences, Public Safety |


Wednesday, April 6th, 2011

Seminar to Help Manufacturers Accelerate the Process of Bringing Reusable Medical Devices to Market

AGAWAM, Mass. – Medical product manufacturers can learn how to accelerate the process of bringing their reusable devices to market in a day-long seminar on May 3, 2011, in Dedham, Massachusetts.

Titled “Bringing Your Reusable Device To Market: Just Because Your Device Lasts Forever Doesn’t Mean The Process of Bringing It To Market Has To,” the seminar will provide an extensive look at the process of introducing such products and help manufacturers answer critical questions such as: “What is required?”; “How much will it cost?”; and “How long will it take?”

The seminar will cover the product introduction process from manufacture of the sterilization tray to the testing that’s required for regulator submittal. Presentations will include:

  • Flushing It Out: New Analytical Methods of Testing on Protein, Hemoglobin, and Carbohydrate
  • Don’t Get Stuck in a Groove: Cleaning Validations Using Microbial Methods
  • What is the Good in Good Laboratory Practices (GLP): Understanding the Process
  • Packaging Your Idea Into Reality: A Look at the Process of Tray Manufacturing
  • One Cycle, Two Cycle, Three Cycle, More?: Sterilization of Your Reusable Devices

The event will run from 8:30 a.m. to 3:30 p.m., with registration and a complimentary continental breakfast starting at 8 a.m. The seminar will be held on Tuesday, May 3, 2011, at the MIT Endicott House, 80 Haven Street, Dedham, Massachusetts. The cost is $149 per person and it includes breakfast, lunch, and workshop handouts.

The seminar is sponsored by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.

To register, contact Julie Adamski at 413-786-1680, toll-free at 800-631-1680, or at jadamski@microtestlabs.com.

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 Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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

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Posted in Biosciences, Health/Medical, Life Sciences, Manufacturing, Technology |


Wednesday, March 30th, 2011

Immunetics Featured at Boston Startup America Event

immunectics1BOSTON, MASSACHUSETTS, March 30, 2011 - “Immunetics came to the South Boston Innovation District after recognizing that an attractive business location with talented people, reasonable facility costs, and access to capital would be a great place to achieve their next stage of growth,” Mayor Menino said. “Now, the city’s partnership with Immunetics has generated benefits that exceeded all of our expectations. Together, we’ve created jobs, won millions of dollars in grants and contracts, and most importantly, achieved medical advances that will help millions of people overcome life-threatening diseases.”

Immunetics President and Chief Executive Officer Dr. Andrew Levin said LifeTech Boston, the Mayor’s program that supports the life sciences industry in the city and is administered through the Boston Redevelopment Authority, helped locate a facility that could support the company’s growth objectives, plus secure a loan to finance its build-out.

“Since then, we have almost tripled the size of our workforce, won over $22 million in grants and contracts, and developed better diagnostics for diseases such as HIV, Lyme disease, and other serious infections that threaten our blood supply,” said Dr. Levin. “Our move to the Innovation District has been the key to Immunetics’ growth and success over the past 7 years.”

The Startup America initiative’s goal is to increase opportunities for entrepreneurs by expanding access to capital, developing education and mentorship programs, and improving collaboration between startup and established companies.

About Immunetics
Immunetics (http://www.immunetics.com) offers state-of-the-art assay technology for infectious disease diagnosis and pathogen detection. For over 10 years, the company has been a leading innovator of tests for bacterial, viral, and parasitic diseases. Immunetics produces and markets a range of infectious disease assay kits and instruments. Its mission is better, cost-efficient care through more accurate diagnosis.

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Posted in Biosciences, Life Sciences |

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