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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.
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.
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.
Labels: combination products, Medical Devices, pharmaceuticals, product development, stability studies, stability study, stability testing, white paper, whitepaper
New FDA Regulations Streamlining the Governance of Combination Products are Detailed in New White Paper
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.”
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.
Labels: biologic, combination products, FDA, Federal Food & Drug Administration, manufacturers, Medical Devices, paper, pharmaceutical, white, whitepaper
Medical Device Professionals to Learn “What They Need to Know” about Manufacturing Combinations Products & FDA Regulations at MD&M East Workshop
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.
Labels: combination products, combo products, MD&M, MD&M East, medical device, medical device manufacturers, medical device manufacturing
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. # # # Labels: combination products, medical device manufacturers, package testing, package validation, package validation testing, Pharmaceutical Manufacturers
New White Paper Helps Medical Device Manufacturers Apply New FDA Regs to Combination Products
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/) 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 MicrotestMicrotest 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. # # # Labels: 21 CFR Part IV, biologic component, biotechnology, combination products, FDA, HCT/Ps, manufacturing, Medical Devices, Microtest Laboratories, pharmaceutical, regulations
Get with the Program: Having a solid package validation program can prevent 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.
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
Labels: combination products, microbiological testing, Microtest Labs, package testing, package validation, physical testing, primary packaging testing, Steven Richter
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. # # #  Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/
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 Technorati tags: Microtest, FDA regulations, white paper, whitepaper, combo products, combination products
Labels: combination products, combo products, FDA regulations, Microtest, white paper, whitepaper
White Paper Advises Pharma Manufacturers on How to Select an Aseptic Fill/Finish Contractor, Avoid the Most Common Mistakes
AGAWAM, MASS. – For pharmaceutical manufacturers, the process of choosing a Contract Manufacturing Organization (CMO) can be a challenging task. The ramifications of making a poor decision can result in schedule delays, regulatory approval issues, and lost revenue. The informative white paper, “ Selecting An Aseptic/Fill/Finish Contract Manufacturer: Avoiding the Most Common Mistake,” focuses specifically on the unique steps involved in selecting and working with an aseptic processing CMO to produce injectable Final Drug Product (FDP). Download it at: http://www.microtestlabs.com/asepticpaper. In addition to providing guidance on the selection process, the white paper also discusses common mistakes made by potential clients. These oversights – and their remedies – are sourced from a collective experience base that covers contract aseptic Fill/Finish (F/F) manufacturing, contract bulk drug manufacturing, and aseptic F/F outsourcing of bulk drug product. “The white paper is authored by John Dobiecki, Vice President of Manufacturing Operations for Microtest Laboratories. Dobiecki’s experience, which spans 25 years in the manufacturing and quality control of pharmaceuticals, medical devices, and biologic products, includes the preparation of INDs, NDA/ANDAs, CMC sections, and Pre-Approval Inspections (PAI), as well as multiple U.S. and European Regulatory Inspections. In the white paper, Dobiecki: Details the nine key components of the RFP – The First Step (in the selection process) Discusses the finer points of Evaluating the Contractor’s Proposal Explains the two types of Site Visits and what should be included on the agenda Provides cautionary tips for making The Selection itself Warns of stumbling into making The Biggest Mistake which can derail a successful selection at any step of the process.
To download the white paper, free of charge, visit: http://www.microtestlabs.com/asepticpaper. 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 http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680. # # # Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/
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Technorati tags: Microtest, FDA regulations, white paper, whitepaper, combo products, combination products Labels: combination products, combo products, FDA regulations, Microtest, white paper, whitepaper
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