Don't Gamble on Extractables & Leachables - You've Got a Lot Riding on This

Extractables & Leachables: You’ve Got a Lot Riding on This

Approaching a product submission to the FDA without full confidence in the container closure system is a big gamble. After investing huge sums in development, why risk lengthy delays, millions in lost sales – or worse yet – a costly, embarrassing recall?

These perils are real. A 2011 survey of parenteral drug development experts found 45% have had marketing applications delayed due to issues with extractables and leachables (E&L), and 24% have had product recalls. More than half the sponsors lack confidence in the clarity of FDA documents and other guidance on container systems. It takes an E&L expert to understand the unique risks of your product and packaging combination.

With so much at stake, it pays to bring in a ringer.

ABC Laboratories offers true expertise in the specialized science of extractables and leachables. We dedicate some of our most talented problem solvers to a special team called the ABC TASC Force (Trace Analysis and Structural Chemistry), representing 200-plus years of experience in polymer chemistry, mass spectrometry, trace analysis and E&L qualification studies…. and we back them with a full house of state-of-the-art instrumentation. Through skilled use of Quality by Design principles, ABC approaches every E&L program with a well-defined scope and a focus on the quality of data each study will produce.

ABC has conducted container closure studies on essentially every form of product and drug delivery device, including higher-risk compounds such as inhalation products and parenterals. What’s more, we understand the regulatory landscape for container closure systems. So, when you choose ABC, you get more than reliable E&L data. You get a development partner who can help optimize your container closure selection. You get the technical horsepower to anticipate and proactively address potential E&L issues before they become concerns. And, you get confidence that your investment will provide the type and depth of data required for a successful submission.