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The Secret Recipe for Extractable/Leachable Testing Success

Every great chef has a secret “something” to their name—a recipe, a technique, an ingredient. It stands to reason that a lab essentially concerned with chemistry would also have its own special something. After all, cooking is a form of chemistry, isn’t it?

While some chefs prefer not to reveal their secrets, we believe you deserve to know exactly who you’re hiring for your next single-use system or container-closure system testing project. So, we’re letting you into the WuXi AppTec “kitchen” to show you how we can deliver exceptional chemistry and toxicology.

Exploring—not just performing—the science

Science requires a thirst for discovery and a willingness to perfect the process to achieve success. We believe taking the time to complete accurate testing is the best way to produce the results our clients need to understand potential safety risks in their products or single-use systems used in the manufacturing process. Our emphasis is on quality and providing complete characterization of the chemicals. What good is a quick and cheap test if it leaves unknowns that could have regulators sending you back to the lab? Or worse—an incomplete data set that leaves patients at risk?

We foster a culture that promotes diving deep into each project, and we aren’t just executing procedures—we’re continually evolving as experts in what we do. We push each other to keep learning and push ourselves by tapping into the knowledge and experience of our colleagues every day.

This culture of scientific exploration works in the highly regulated, time-sensitive drug development industry because we pair it with a dedication to maintaining the resources necessary to keep projects moving forward. We add instrumentation and equipment proactively to keep things running smoothly, and we are continuously expanding our compound database—thanks to the determined and skilled chemists who take the time to do the elucidation needed for identification. When reference standards are available, we confirm the identification and add it to our library. Our team of expert scientists has continued to expand to ensure all the elements necessary to conduct superior chemistry and toxicology testing are in place at our lab in St. Paul, Minn.

Stepping up when the technology falls short

Another key ingredient to our culture is our scientists’ ability to solve complex elucidation puzzles and uncover potential issues that a machine might miss. Where some labs might depend primarily on software and automation, we emphasize problem-solving and due diligence. While this can require more time, we stand by the investment in thorough testing, and our legacy clients can recount stories where this has led to material discoveries they weren’t anticipating. For example, extractable/leachable chemicals in plastic components can go undetected and impact the product’s overall safety. By thoroughly identifying all chemicals, our clients can rest assured their product is safe and ready for regulatory scrutiny.

When it comes to extractable/leachable studies and safety assessments/toxicological risk assessments, you need more than just great equipment. You need highly trained experts to interpret the data and to arrive at complete identification. While the methods themselves may be similar no matter which lab you work with, the commitment to complete identification differ from lab to lab. Complete identification is possible and should be expected. Don’t settle for less.

WuXi AppTec analysts are trained experts, and our approach to data processing allows us to catch any anomalies or potential issues early, which is key to achieving a successful outcome. We work as an extension of your team. You have direct access to our experts. We proactively communicate any potential changes to your project or timeline. Working with WuXi AppTec, you will never be caught off guard.

Technology will only get you so far

Our trained experts and our commitment to you are the secret ingredients to your successful program. We do two things to ensure our experts are the best in the business. First, we look for qualified scientists with a curious mind, with patience and persistence to solve complex problems. We seek out those with a daring penchant to take new and creative approaches to the field.

Second, we train extensively in our labs to ensure that we consistently provide high-quality data. New hires spend considerable time with senior analysts, well-versed in adjusting to the needs of each project.

You can buy state-of-the-art equipment, but you have to build a team of highly trained, curious scientists who work together to leave no stone unturned and genuinely care about what the test results mean for each project. That takes a culture of doing the right thing, even if it takes more resources to reach your goals. There is no “good enough,” no completing the test and moving on without a thorough assessment. Unknowns are Unacceptable™. Period.

Recipe for success

Science isn’t prescriptive; you need the right conditions and the right minds to make it work. At WuXi AppTec, these come together as the “secret sauce” to success. And that secret sauce is why you can feel confident leaving your product testing needs in our hands.

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