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

AGAWAM, MASS. – 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, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Environmental Monitoring and Certification in Controlled Environments - New White Paper

AGAWAM, MASS. – August 10, 2011 – Environmental testing and monitoring programs are essential elements in pharmaceutical and medical device manufacturing. Companies must understand industrial sterilization and contamination control procedures to bring products to market on time and on budget.

In attempting to meet regulatory demands from sources such as the U.S. FDA and the European Pharmacopoeia, the greatest challenge for medical device and pharmaceutical manufacturers may be determining what exactly is required for compliance. How must manufacturers design, implement, certify, and maintain correct sterilization and environmental monitoring programs?

Unfortunately, there is no single reference document that U.S. manufacturers may rely upon to help them design, validate, and demonstrate room class compliance. Nor, given the monumental scope of the task, is it likely that one will be drafted anytime soon.

But a new, free white paper titled “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” available for free download at http://www.microtestlabs.com/environmentpaper, may help.

The white paper reviews the key elements of a best-practice environmental testing program, including sterilization standards, FDA requirements, and the critical factors in maintaining controlled environments. Topics include: What Is Required; Viable vs. Nonviable Particulates; Sampling Plans; Validation Management; Sterilization Programs; Cost/Product Savings; Critical Factors; and The Benefits of Experience. The paper also discusses how these challenges may be met with the assistance of an update-to-date testing laboratory.

The white paper is authored by Steven Wieczorek, Supervisor, Environmental Sciences, who leads the Environmental testing, monitoring, and certification groups at Microtest Laboratories, a leading provider of regulatory microbiology and contract laboratory services based in Agawam, Mass.

Download the new, free white paper, “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” at http://www.microtestlabs.com/environmentpaper.

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, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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