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ABC Brings Unsurpassed Technical Expertise and Capabilities to E&L Programs
Nothing sends a development team into red alert like impurities discovered late in development. That said, it is well understood that packaging and other container-closure systems can interact with even the most stable formulation.
By applying Quality by Design (QbD) principles to your extractables and leachables program, the experts at ABC Laboratories will help reduce the risk of surprises and keep your NDA filing on track. Our approach combines a solid understanding of compound chemistry, careful analysis of potential E&L risks and well-thought-out study design to address regulatory data requirements in an efficient and cost-effective manner. This approach to identifying and quantifying unknown peaks of interest effectively controls "scope creep" often associated with these types of studies. And if a situation calls for a reference standard, our in-house synthesis team is on hand to deliver custom reference material, complete with certification of analysis, quickly.
Extractables and leachables studies often require specialized skills and instrumentation, and ABC Laboratories is well-equipped with both. Our Trace Analysis and Structural Chemistry (TASC) team has more than 100 years of experience in complex chemistry, advanced ID and quantification techniques. They bring to the table expertise in mass spectroscopy and nuclear magnetic resonance interpretation, as well as broad-based polymer knowledge that can be central to container-closure analyses. We offer expertise across all types of delivery systems–metered dose and dry powder inhalers, syringes, vials, stents, infusion pumps and more.
Of course, when you're dealing with complex identification and quantification work, even the best scientists need the right analytical tools. ABC's new 90,000 square-foot pharmaceutical development facility is well-equipped with industry-leading Time of Flight (ToF)/MS, Ion Trap, LC MS/MS and other specialized instruments. ABC Laboratories has extensive, proven experience performing Extractables & Leachables studies on inhaled nasal drug products, injectable solutions, oral inhalation products and more.
But it's not just superior science that sets ABC apart, it's the way we run our business: defined processes, performance metrics, professional program management and a culture of continuous improvement help ensure quality, on-time delivery, excellent communication and lasting client relationships. We call it "The ABC Difference."
To learn more about ABC's Extractables and Leachables capabilities, click here. Or, contact one of our E&L subject matter experts. |
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