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.

“Combination Products: What You Need to Know” Seminar for Medical Device, Pharmaceutical Manufacturers is Scheduled for October 31st in Boston

A full-day technical seminar designed to assist medical device and pharmaceuticals with what they need to know about manufacturing combinations products, including best practices and applicable FDA regulations, is scheduled for Thursday, October 31^st, in Waltham, Mass., just outside Boston.

Combination products are a large and growing segment of the medical device market. Some analysts estimate they represent more than 30% of all new FDA product submissions. But for manufacturers, the convergence of drugs, biologics, and devices presents a host of best practice and regulatory issues.

Titled “Combination Products: What You Need to Know,” the seminar will outline a realistic approach for manufacturers to navigate the testing, production, and regulatory standards related to the manufacture of combination products. Topics will include:

• Combination Products —What You Need To Know: Overview of regulatory hurdles for combination products highlighting the determination of PMOA.
• Applications of Lean to Combination Product Manufacturing: Case studies specific to applying lean to manufacturing of combo products for clinical use.
• In-Process and Release Testing PTC: Outline of in-process and release testing points to consider during development and specification determination.
• EM Monitoring of GMP Manufacturing Space: Current EM procedures for setting up GMP manufacturing.
• Choosing the Right CMO: Discussion of best practices to determine a right fit CMO.

“Combination Products: What You Need to Know,” will be presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. The seminar will be held at the Conference Center at Waltham Woods in Waltham, Mass., just outside Boston, on Thursday, October 31, 2013, from 9:00 a.m. to 3:00 p.m. Registration is at 9:00 a.m. Continental breakfast, break refreshments and luncheon is included.

To register, download the form at http://www.microtestlabs.com. Or, contact Julie Adamski at Microtest Laboratories by phone at 1-800-631-1680, ext. 192, or by email at jadamski@microtestlabs.com. The registration fee is $149.

The seminar is one in a continuing series of technical events presented by Microtest Laboratories for medical device and pharmaceutical manufacturers. The seminars tend to fill up quickly so please register early! Follow Microtest Laboratories on Facebook at http://goo.gl/pHNP63, on LinkedIn at http://goo.gl/H8ZLnM or on Twitter @MicrotestLabs.