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Posts Tagged ‘combination products’


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, 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, 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, July 13th, 2010

New White Paper Helps Medical Device Manufacturers Apply New FDA Regs to Combination Products

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AGAWAM, MASS. – July 13, 2010 – A new free, white paper that guides medical device manufacturers in the complicated process of applying new U.S. Food and Drug Administration (FDA) regulations to combination products embedded with pharmaceutical or biologic components is now available from Microtest Laboratories (http://www.microtestlabs.com/combination-products-20/).wpcover1

Combination products are a large and growing segment of the medical device market, with some analysts estimating they represent over 30% of all new product submissions to the FDA. As the market continues to grow, it is further compounded by the introduction of human tissue and cellular products (HCT/Ps) incorporated in combination products, which in turn, raise a host of new challenges for testing, sterilization, and contamination avoidance.

Over the past 12 months, the FDA has addressed the dichotomy of dual quality systems by developing streamlined regulations for Good Manufacturing Compliance. These regulations, designated as 21 CFR Part IV, are anticipated to become law by the end of 2010.

Once promulgated, manufacturers will be held accountable for compliance and the FDA will use it as a legal document for enforcement. In the new white paper titled, “Combination Products 2.0: Applying the New FDA Regulations,” Steven Richter, Ph.D, President and Chief Scientific Officer of Microtest Laboratories, Inc., addresses the implications for manufacturers. (Download from: http://www.microtestlabs.com/combination-products-20/). In the white paper, Dr. Richter discusses:

  • The New Regulations
  • Determining Principal Mode of Action — Device or Drug?
  • Stem Cells & Human Tissue in Combination Products
  • The Implications for Testing and Validation
  • An Example: Drug-Eluting Stents

“The new FDA regulations governing combination products are a major step forward for the industry. They apply to 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 IV closes the gaps in the 2004 guidelines and succinctly clarifies the process for establishing quality systems that ensure compliance and patient health and safety. The ability of manufacturers to understand, establish, implement reliable testing procedures will be critical in complying with these new requirements,” Dr. Richter said.

Download a free copy of “Combination Products 2.0: Applying the New FDA Regulations” from http://www.microtestlabs.com/combination-products-20/.

Dr. Richter founded Microtest in 1984 after a distinguished career at the U.S. Food & Drug Administration. Under his leadership, Microtest provides 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, May 24th, 2010

Get with the Program: Having a solid package validation program can prevent failure of combination products

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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.

Read the new bylined article by Steven Richter, “Get with the Program: Having a solid package validation program can prevent failure of combination products,” for insight into the general requirements in a microbiological and physical testing program. It also discusses how combination products pose a unique set of challenges to package validation engineers.

Published May 2010 in MD&DI, at http://ht.ly/1P7lO

Steven Richter, PhD, is founder, president, and chief scientific officer of Microtest Laboratories Inc. (Agawam, MA).


Thursday, March 26th, 2009

Texcel Medical Appoints John Mulvihill as Vice President, Sales and Marketing

East Longmeadow, Mass. – March 26, 2009 – Texcel Medical, a full service medical device process design, development and contract manufacturing company, has announced the appointment of John Mulvihill as Vice President, Sales and Marketing.

Mulvihill, 49, of East Longmeadow, Mass., will direct the sales and marketing functions at Texcel Medical, which helps companies around the world by providing the manufacturing infrastructure and expertise they need to accelerate the commercialization of their surgical, interventional, multiparameter, and implantable medical device technologies. The firm is headquartered in East Longmeadow, Mass.

Texcel Medical President and CEO Barry Smith reinforced the significance of Mulvihill’s appointment. “John’s previous experience in the medical electronics industry and his achievements in leading and developing highly successful market driven teams is an ideal complement to Texcel Medical’s strategic growth initiatives as we move forward in creating long term partnerships with our clients,” Smith said.

Prior to joining Texcel Medical, Mulvihill served as Business Development and Vice President of Sales and Marketing for several medical device product and engineering companies. Most recently, Mulvihill was with Greatbatch, Inc., of Clarence, NY.

Texcel Medical’s 20+ years of experience provide companies increasingly sophisticated designs through reliable manufacturing, with particular expertise in Orthopedics, Cardiac Assist, Active Implantables, Combination Products, and General Instrumentation.

For more information, visit Texcel Medical’s website at www.texcelmedical.com or contact John Mulvihill at Texcel Medical, 55 Deer Park Drive, East Longmeadow, MA 01028, or by phone at (413) 525-5700 ext. 1010.

About Texcel Medical:
Texcel Medical (www.texcelmedical.com) creates long term partnerships with medical device companies in the areas of Class II medical electronics, Class III implantable electronics, IPG’s (Implantable Pulse Generators – Neuromodulation) and laser technology and manufacturing services. Texcel Medical has served the medical device community for over 20 years and is ISO-13485 (2003) certified.

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Public Relations contact: Tiziani Whitmyre, Inc., www.tizinc.com/services/public-relations/

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Monday, February 23rd, 2009

Texcel Medical Appoints Barry Smith as President, CEO

East Longmeadow, Mass. — February 23, 2009 – Texcel Medical, LLC, a full service medical device process development and contract manufacturing company, has announced the appointment of Barry Smith as President and CEO.

Smith will oversee all functions at Texcel Medical, which helps companies around the world by providing the manufacturing infrastructure and expertise they need to accelerate the commercialization of their surgical, interventional, and implantable medical device technologies. The firm is headquartered in East Longmeadow, Mass.

Texcel Medical Founder and Chairman Laurence Derose, emphasized the significance of Smith’s appointment. “Barry’s executive experience in the medical products market is an ideal compliment to Texcel’s strategic growth initiatives as we move to the next level as a long term partner,” Derose said.

Prior to joining Texcel, Smith served as Chief Operating Officer and Vice President of Operations and Product Development for several medical device product and engineering companies.

Derose continues in his role as Chairman and will expand his focus on identifying and securing strategic partnerships for the organization.

Texcel Medical’s medical device process development and manufacturing solutions and services includes design for manufacturability (DFM), design history file management, inventory management, quality and regulatory assistance, and process validation, along with general manufacturing, electronic testing, laser welding, and clean-room processing for a wide range of product applications. Texcel Medical has more than 20 years of experience assisting companies execute increasingly sophisticated designs through reliable manufacturing, with particular expertise in Orthopedics, Cardiac Assist, Active Implantables, Combination Products, and General Instrumentation.

For more information, visit Texcel Medical’s website at http://www.texcelmedical.com/ or contact Keith Checca at Texcel Medical, 55 Deer Park Drive, East Longmeadow, MA 01028, or by phone at (413) 525-5700.

About Texcel Medical:
Texcel Medical, LLC (http://www.texcelmedical.com/), a full service medical device process development and contract manufacturing company, creates long term partnerships with medical device companies in the areas of Class II medical electronics, Class III implantable electronics, IPG’s (Implantable Pulse Generators – Neuromodulation) and laser technology and manufacturing services. Texcel Medical has served the medical device community for over 20 years and is ISO-13485 (2003) certified.

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Public Relations contact: Tiziani Whitmyre, Inc., www.tizinc.com/services/public-relations/

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Tuesday, February 10th, 2009

Texcel Highlights Medical Device Development & Manufacturing Solutions


East Longmeadow, Mass. — February 10, 2009 — Texcel’s custom medical device development and manufacturing solutions helps companies around the world accelerate the commercialization of their surgical, interventional, and implantable medical device technologies. Texcel will highlight its full array of services and technologies at the MD&M West Expo, February 10-12, 2009, in exposition booth # 314.

Texcel provides the manufacturing infrastructure and expertise for a wide range of product applications – from endoscopic surgical instrumentation and spinal/orthopedic implants to total artificial hearts and neurostimulators.

Texcel’s specialized services and full medical device solutions include device design, development history file management, quality and regulatory assistance, process validation, along with general manufacturing, electronic testing, laser welding, and clean-room processing for a wide range of product applications.

Texcel, with more than 20 years of experience assisting companies execute increasingly sophisticated designs through reliable manufacturing, has particular expertise in five key areas:

  • Orthopedics, including products ranging from metal bone fastening devices to novel new materials;
  • Cardiac Assist, with expertise helping industry pioneers assemble and produce many types of cardiac assist devices;
  • Active Implantables, including a wide range of metal and non-metal biocompatible materials as well as dynamic mechanical and electrical features;
  • Combination Products, combining strong internal development and manufacturing capabilities with partners specializing in pharmaceuticals.
  • General Instrumentation, including a wide array of interventional products from durable medical equipment components to disposable catheter devices, and a full range of materials and assembly methods.

“By combining our comprehensive, highly integrated suite of capabilities and state of the art production facility into a single, seamless solution, we manage all the concerns of development and manufacturing process for our clients. We thus empower our clients to focus other priorities, such as developing new markets and therapies based on their proprietary technologies,” said Keith Checca, Director of Business Development, Texcel, (http://www.texcelmedical.com/).

The company is staffed with over fifty (50) talented, experienced, and passionate medical device industry employees within an ISO 13485 and ISO 9001 environment.

Based in East Longmeadow, Massachusetts, Texcel works with companies around the world.

For more information, visit Texcel at MD&M West 2009 in booth # 314; online visit http://www.texcelmedical.com/, or call 413-525-5700.

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Download high resolution images from: http://www.flickr.com/photos/10956940@N08/sets/72157613280222222/

Public Relations contact: Tiziani Whitmyre, Inc., www.tizinc.com/services/public-relations/

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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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