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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 25th, 2014

April 9th Webinar Will Show Environmental Health and Safety (EHS) Managers How to Automate Tasks, Save Costs with Microsoft SharePoint; Presented by EH&E

Needham, Mass.— March 25, 2014 — A free April 9th webinar will show environmental health and safety managers how to streamline their EHS programs —saving costs and time — by automating key administrative tasks with Microsoft® SharePoint®, a software platform available within most companies and institutions.

EHS programs involve numerous repetitive administrative tasks — information transcription, information transfer to responsible personnel, and follow-up notifications. These consume a significant amount of valuable labor — and take away from time spent on important EHS initiatives.

By using SharePoint’s powerful workflow tools, environmental health and safety managers can automate most routine tasks related to information processing and maintaining compliance — saving countless hours and costs while improving both program efficiency and compliance.

The webinar — “SharePoint – More than Data Storage: Workflows Automate Key EHS Administrative Tasks” — will feature real-world examples to demonstrate how SharePoint workflows can be applied to:

  • Data screening and calculations — automatically flag deficiencies, calculate and compare data to pre-determined limits
  • Task notifications — send automated alerts of pending deadlines or overdue tasks
  • Approvals — automate the routing of forms and reports for review (incident reports, risk assessments, etc.)
  • Corrective Actions — manage documentation and track completion

The webinar is designed for EHS managers and directors, safety officers, biosafety officers, laboratory managers, and administrators and IT personnel. It will be held on Wednesday, April 9, 2014, from 1 p.m. to 2 p.m. Eastern Time. To register, visit http://www.eheinc.com/news_workshops/sharept_workflows_ehs.htm. There is no cost to register nor attend.

“SharePoint – More than Data Storage: Workflows Automate Key EHS Administrative Tasks” will be presented by EH&E, a leading provider of environmental and engineering consulting services. Its EHS Automation Consulting services to help companies and institutions achieve greater compliance, time and cost savings by automating their environmental health and safety programs with Microsoft SharePoint. For more information, call 1-800-825-5343 or visit www.eheinc.com/ehe_web_solutions.htm.

About EH&E

EH&E (www.eheinc.com) has provided an extensive range of environmental and engineering consulting services for 25 years. The EH&E team consists of more than 60 experts with an outstanding record of providing business-focused solutions for issues that affect the built environment. EH&E has a depth of knowledge and credibility unmatched in the industry.

Microsoft® and SharePoint® are registered trademarks of Microsoft Corporation.


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, 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, October 22nd, 2013

Use of Stability Studies in Drug, Combination Products & Medical Device Development are Reviewed in New Whitepaper

AGAWAM, MASS. — October 22, 2013 —The use of stability testing in new product development — of drug substances, drug products, combination products and some medical devices — is reviewed in a new whitepaper from Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.

The paper, “The Use of Stability Studies in Pharmaceutical and Combination Product Development” (download from: http://microtestlabs.com/stability-studies), outlines how stability studies can be used to gather valuable information about a new product and prevent unnecessary manufacturing costs and time delays.

Stability studies can help determine formulation and manufacturing strategy, analytical assay development and validation — and help explain unexpected and failing results. They can also provide input to manufacturing controls, and help identify final packaging requirements. The paper examines three specialized stability studies as examples:

  • Forced degradation studies, which involve exposing the product to predetermined stress conditions in order to intentionally form likely degradation products;
  • Photostability testing, used to determine the product’s ability to withstand exposure to light without any adverse effects;
  • Temperature cycling studies, used to assess the impact of temperature changes on the product.

Two case studies, one involving a drug product and one a combination product, are also presented.

The use of stability studies in the development of new drug or combination products can ease both the planning and execution of a development strategy. Moreover, the studies may also help prevent unnecessary costs and time delays due to poor formulations, assay failures, and manufacturing problems.

Download the new whitepaper, “The Use of Stability Studies in Pharmaceutical and Combination Product Development,” from: http://microtestlabs.com/stability-studies.

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


Tuesday, October 15th, 2013

Immunetics Introduces Updated BacTx Analyzer for Use with its BacTx Rapid Test for Bacterial Contamination of Platelets

Boston, MA — October 14, 2013 — Immunetics, Inc., a leading clinical test provider, today introduced the updated BacTx® Analyzer for use with its BacTx rapid test for bacteria in whole-blood derived and apheresis platelets. The Analyzer offers automated interpretation, tracking, and documentation — features that not only increase transfusion patient safety, but also provide seamless integration with the laboratory workplace.

The BacTx assay gives hospitals and blood banks a practical tool for assuring the safety of their platelets. The colorimetric assay can detect aerobic, anaerobic, gram-negative and gram-positive bacteria in a single test. The test is designed to enable testing closer to time of transfusion, to reduce the risk of transfusing contaminated platelets.

The updated BacTx Analyzer delivers a faster turnaround of results and a host of new automation and workflow-enhancement features. Complete assay results and analysis are delivered within 30 minutes. STAT, control, and standard assay capabilities allow for testing flexibility. Designed for simple, easy integration, the BacTx Analyzer fits seamlessly into the existing workflow of any laboratory or transfusion center.

“Today, the bacterial contamination of platelets represents a significant risk to the highly vulnerable patients that require transfusions. Existing approaches to detecting bacteria have fallen short, and the industry’s need for an effective, low-cost testing technology is greater than ever,” said John Yonkin, Chief Executive Officer of Immunetics. “Highly sensitive, specific bacterial detection, as provided by the BacTx rapid test with the BacTx Analyzer, helps improve the quality of patient care.”

Features of the updated BacTx Analyzer include:

• Easy and efficient sample preparation;

• Bar code scanning to minimize user input error and maximize efficiency;

• Random access testing that allows multiple assays to be run at different times;

• LED touch screen to simplify operation;

• Logical workflow to accelerate users’ learning curves;

• Passcode and user ID entry that adds security during testing;

• Visual confirmation on both the analyzer and touch screen for best-practice quality control (QC), tracking, and platelet management;

• Automated tracking of tests, trends, and QC;

• USB port for quick and easy download of data

• Small footprint for crowded, cramped lab space.

The BacTx system utilizes a patented, highly specific, universal bacterial detection reagent that has been shown to detect wild and cultured bacterial strains. The assay meets AABB standard 5.1.5.1.1. and can be used for quality-control testing of:

• Leukocyte-reduced apheresis platelets (LRAP) within 24 hours of transfusion, following testing with an FDA-cleared growth-based bacterial detection device.

• Pools of up to six units of leukocyte-reduced whole-blood derived platelets that are pooled within 4 hours of transfusion.

For more information on the BacTx Rapid Assay System, visit the Immunetics Website at http://immunetics.com/bactx.html or contact Immunetics at 1-617-896-9100 or toll-free at 1-800-227-4765.  Immunetics will be displaying the BacTx System at the AABB Annual Meeting and CTTXPO in Booth #527.

About Immunetics

Immunetics, Inc. offers state-of-the-art assay technology for infectious disease diagnosis and blood screening, and for more than 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. The company has issued patents on its BacTx test for bacterial contamination of platelets. It has developed and markets other FDA-cleared products, including a test for Lyme disease, and is actively working on new tests for Babesiosis and Chagas disease — both of which are emerging risks to the blood supply. Immunetics is headquartered in Boston, Massachusetts. The company’s mission is to deliver better cost-efficient care through more accurate diagnosis. For more information, visit the Immunetics website at http://immunetics.com.

BacTx® is a registered trademark of Immunetics, Inc.


Tuesday, September 10th, 2013

New FDA Regulations Streamlining the Governance of Combination Products are Detailed in New White Paper

AGAWAM, MASS. — September 10, 2013 — New Federal Food & Drug Administration (FDA) regulations have streamlined the governance of combination products — medical devices embedded with pharmaceutical or biologic components. A new white paper titled “Combination Products 3.0: Applying the New FDA Regulations in 2013” discusses the implications for manufacturers. The whitepaper is available to download at http://microtestlabs.com/combination-products-30.

Combination products are a large and growing segment of the medical device market. Some analysts estimate they represent over 30% of all new FDA product submissions.

“Over the last 10 years, FDA regulatory centers have struggled with the changes and challenges that these new technologies present. For manufacturers, the convergence of drugs, biologics, and devices has created both a host of regulatory issues — and many exciting opportunities,” according to Steven Richter, Ph.D, President and Chief Scientific Officer of Microtest Laboratories, Inc., and author of the new white paper.

The new FDA publication, “21 CFR Part 4 — Current Good Manufacturing Practice Requirements for Combination Products,” revises regulations by establishing different categories of products. These included single-entity products (such as a drug-eluting stent) and co-packaged products (such as a packaged syringe and pharmaceutical). The rules also distinguished between a drug with a device, a biologic with a device, and a device with an HCT/P.

 

The new white paper discusses, in detail and example, how the new FDA rules guide a manufacturer into one of two approaches, depending upon the characteristics of their product.

 

According to Dr. Richter, “the FDA’s new streamlined approach for regulating combination products is a big step forward for the practitioner. It applies parts of both the QSR and GMP quality systems in a way that makes sense for the unique characteristics of each combination product. 21 CFR Part 4 closes the gaps in the 2004 guidelines and succinctly clarifies the process for establishing quality systems that ensure compliance and patient health and safety.”

Download the new white paper, “Combination Products 3.0: Applying the New FDA Regulations in 2013,” from http://microtestlabs.com/combination-products-30. The white paper is presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.

Based in Agawam, Mass., 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 about Microtest Laboratories, visit 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.


Tuesday, September 3rd, 2013

New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos to be Discussed at AMI’s Medical Grade Polymers 2013

AGAWAM, MASS. – September 3, 2013 – A new test that utilizes Zebrafish (Danio rerio) embryos to screen plastics, composites, and polymers for toxicity in medical device manufacturing will be featured at AMI’s Medical Grade Polymers 2013 technical conference in September.

“The U.S. Food and Drug Administration (FDA) requires testing to assess medical device toxicology and describes which situations may trigger the need for manufacturers to repeat testing or undertake new programs. The dynamics of such testing are rapidly evolving,” according to Steven Richter, Ph.D., president and scientific director of Microtest Laboratories, and a former FDA official.

Dr. Richter developed the new “ZET™ Medical Device Polymer Biocompatibility Screen Test,” at Microtest Laboratories for use by medical device manufacturers and bio-material researchers.

 

“Zebrafish are extensively used in drug development studies due to their transparent embryos and fast development times. The Zebrafish test demonstrates similarities to mammalian models and humans. Its unique approach to fast-track medical device toxicity screens will save manufacturers time and reduce expenses,” he said.

 

“Moreover, Microtest’s ZET Test sensitivity has proven to be greater than the USP gold standard test for BPA. In addition, the benefits of ZET surpass both USP cytotoxicity testing and mouse embryo toxicity tests,” he said.

 

Dr. Richter will present details of the new ZET Test in his presentation, “Biocompatibility Testing: Past, Present, and Future,” on Tuesday, Sept. 17, at 10:10 a.m., at the Applied Market Information LLC (AMI) Medical Grade Polymers 2013 conference. The conference runs Sept. 17-18, at the Crowne Plaza, Boston/Woburn, Mass. For more information, visit http://goo.gl/o9edjx.

For more information about Microtest Laboratories’ new ZET Test, download the white paper, New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos (Danio Rerio),from http://www.microtestlabs.com/zebrafish-test-paper.

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, 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.


Tuesday, July 9th, 2013

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

AGAWAM, MASS. — July 9, 2013 — 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.

“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.

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).

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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