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

Posts Tagged ‘combo products’


Tuesday, June 4th, 2013

Medical Device Professionals to Learn “What They Need to Know” about Manufacturing Combinations Products & FDA Regulations at MD&M East Workshop

AGAWAM, MASS. — Medical device professionals will learn what they need to know about manufacturing combinations products and FDA Regulations at a workshop to be featured at MD&M East, the world’s largest medical OEM event, in Philadelphia on Tuesday, June 18, 2013.

Titled “Combination Products: What You Need to Know,” the workshop will outline a realistic approach for medical device professionals to use in navigating the regulatory standards required for the approval, marketing, and manufacture of combination products. Topics will include:

  • Defining a Combination Product
  • Current and pending FDA regulations re: their approval, marketing, and manufacture
  • Self-assessing the Primary Mode of Action (PMOA)
  • Integrating with the FDA through the Request for Designation (RFD) Guidance from the Office of Combination Products (OCP)
  • GMP issues involving the manufacture of a drug component with a medical device
  • Differences between medical device cGMPs and pharmaceutical cGMPs: Jargon, regulations, and general culture
  • Real-world case studies
  • Questions & answers

Microtest Laboratories Director of Project Management, Manufacturing, Alex Mello will lead the workshop. Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Mello has more than 20 years of experience in Aseptic Fill/Finish, Microbiology, Method Transfer, Stability of Drug Product, Medical Devices/Combo Products, and Sterilization Sciences. He holds a graduate degree in Biological Sciences and is a Specialist Microbiologist (NRCM).

Combination Products: What You Need to Know” will be featured at MD&M East as part of the event’s “Innovation Briefs” series. The workshop will be held on Tuesday, June 18 at 1 p.m. in booth #957. Attendance is free for MD&M East guests and participants. For more information, contact Microtest Laboratories by phone at 1-800-631-1680 or by email at amello@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.


Tuesday, November 16th, 2010

New White Paper: Having a Solid Package Validation Program Can Prevent Failure of Combination Products

AGAWAM, MASS. – November 16, 2010 – A new white paper urges medical device and combination product manufacturers to employ a solid package validation program as a means of preventing the failure of combination products.

“FDA concerns regarding terminally sterilized medical products are based on years of data that implicate failures in primary packaging. Approximately 47% of failures occur due to inadequate package validation programs,” said Steven Richter, Ph.D., founder, president and chief scientific officer of Microtest Laboratories in Agawam, Mass.

Richter is author of the new white paper that provides insight into the general requirements in a microbiological and physical testing program. In it, he discusses how combination products pose a unique set of challenges to package validation engineers.

Titled, “Get with the Program: Having a Solid Package Validation Program Can Prevent Failure of Combination Products,” the paper is available for download from: http://www.microtestlabs.com/packaging-validation-paper.

In the white paper, Richter discusses the challenges of packaging validation and some of the options for testing. He provides a summary of the standardized test methods commonly used in the U.S. for satisfying ANSI/AAMI/ISO 11607 requirements, and outlines the steps in the packaging validation process. He also focuses on the points to consider during packaging validation studies for cell therapy products.

“All device and combination product manufacturers are required to have a robust package validation program, and medical device stability package validation programs should be designed to encompass the overt product storage and shipment conditions,” Richter said. “The necessity to develop a robust packaging validation regimen cannot be overstated. A comprehensive regulatory approach to validation during early product development can save many weeks of redevelopment and testing activities.

“This white paper is presented to give medical device and combination product manufacturers a starting point for package validation programs,” he said.

Download the new, free white paper, Get with the Program: Having a Solid Package Validation Program Can Prevent Failure of Combination Products,” from: http://www.microtestlabs.com/packaging-validation-paper.

Steven Richter, Ph.D., is founder, president, and chief scientific officer of Microtest Laboratories, Inc., in Agawam, Mass. Dr. Richter founded Microtest in 1984 after a distinguished career at the U.S. Food & Drug Administration. Under his leadership, Microtest has provided the medical device, pharmaceutical, and biotechnology industries with premier testing and manufacturing support.

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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Public Relations contact, Boston:  Don Goncalves, dgoncalves@tizinc.com, 781-793-9380, for Tiziani Whitmyre Inc., http://www.tizinc.com/public-relations


Monday, December 1st, 2008

White Paper Addresses FDA Approval Challenges Facing Combination Product Manufacturers

AGAWAM, MASS. – December 1, 2008 – Even as the combination products market continues to experience dramatic growth, the approval process facing manufacturers seeking to introduce new medical devices embedded with pharmaceutical or biologics components is expected to become even more challenging and complex.

“Given the convergence of technologies, combination product manufacturers – often either medical device or pharmaceutical companies “crossing over to the new market” – must ensure their products meet cGMP practices as well as pass muster with the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and The United States Pharmacopeia (USP),” said Steven Richter, Ph.D., President & Chief Scientific Officer of Microtest Laboratories, and a former FDA official.

“The combination products market is rapidly moving forward with a new direction and emphasis regarding product safety and FDA requirements,” said Richter. “The process, already complex, is likely to become even more so,” he warned.

In fiscal 2007, the FDA received 333 original applications for combination products, a 42 percent increase over 2006. The FDA itself reports that combination product submissions “raise challenging regulatory, policy, and review management issues… (that) can impact the regulatory processes of all aspects of the product life cycle.”

In the free white paper, “Combination Products: Navigating Two FDA Quality Systems,” Richter provides a helpful overview of the challenges facing combination product manufacturers. Download the white paper at www.microtestlabs.com/combinationpaper.

“For manufacturers, the convergence of devices and drugs or biologics brings a host of new FDA testing guidelines, practices, and regulations unique to the development and production of combination products – and generally outside their original core competence in achieving regulatory approvals as either a medical device or pharmaceutical manufacturer,” he said.

In the white paper, Richter discusses: Defining the Convergence, FDA Responsibility, QC Drug Release Criteria, Biologics, New Developments in FDA Thinking, and Future Considerations.

According to the FDA, some estimate the total global value of the drug-device combination products market will grow to $11.5 billion in 2010, up more than double from $5.4 billion in 2004.

Download the free white paper at: www.microtestlabs.com/combinationpaper. 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, 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. 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/

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Monday, December 3rd, 2007

Free White Paper Addresses Challenges of New FDA Regulations Awaiting Combo Product Manufacturers

AGAWAM, MASS. – December 3, 2007 – A new, free white paper, addressing the challenges of new U.S. Food and Drug Administration (FDA) regulations awaiting combination products manufacturers, is now available for download at www.microtestlabs.com/combinationpaper.

While combination products are experiencing dramatic growth, the convergence of drug/biologics and devices brings a host of regulatory challenges. Manufacturers must ensure their products meet cGMP practices as well as pass muster with the FDA, ISO, and USP.

Steven Richter, Ph.D., Microtest President & Chief Scientific Officer, addresses the critical issues associated with this complex process, including defining the FDA’s regulatory framework, reviewing developments in FDA thinking, and identifying future considerations in developing effective quality assurance systems.

“The combination products market – medical devices embedded with pharmaceutical or biologics components –is rapidly moving forward with a new direction and emphasis regarding product safety and FDA requirements,” said Richter, who is author of the announced white paper, “Combination Products: Navigating Two FDA Quality Systems.”

Navigant consulting, estimating the combination products market at $5.9 billion in 2004, predicts a nearly $9.5 billion market in 2009. In 2005, the FDA received 275 combo product submissions, and an estimated 30% of new products under development today are combo products.

“For manufacturers, the convergence of devices and drugs or biologics also brings a host of new FDA testing guidelines, practices, and regulations unique to the development and production of combination products,” he said.

The paper’s contents include: Defining the Convergence, FDA Responsibility, QC Drug Release Criteria, Biologics, New Developments in FDA Thinking, and Future Considerations.

Download the free white paper at: www.microtestlabs.com/combinationpaper. 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 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

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