Analytical Development Sevices
At Wheeler Bio, we recognize the critical role of analytical development and qualification in ensuring the safety, quality, and efficacy of biopharmaceutical products. Our state-of-the-art Oklahoma City Integrated Process Development Lab is equipped to provide comprehensive analytical services to accelerate your drug development journey. Our comprehensive suite ensures all analytical methods are fully characterized to support subsequent development and manufacturing operations and keep your program in good regulatory standing.
Leverage Wheeler Bio’s comprehensive suite of solutions to meet your analytical needs.
Our Oklahoma City Development Center’s analytical development team is committed to designing and optimizing robust analytical methods tailored to your candidate’s regulatory requirements. Leveraging our expertise and advanced instrumentation, we offer a wide range of analytical development services:
Our scientists employ their deep understanding of various analytical techniques to develop reliable and sensitive methods for product characterization, impurity profiling, potency determination, and more. We collaborate closely with clients to ensure that the developed methods align with their specific needs.
We continuously refine and optimize existing analytical methods to enhance their sensitivity, accuracy, and robustness. Our goal is to maximize the efficiency of your analytical testing while maintaining the highest quality standards.
Wheeler Bio’s analytical capabilities extend to stability testing, where we evaluate the product’s stability profile under various conditions. Our comprehensive stability testing protocols help you determine the shelf life, storage requirements, and formulation stability of your biopharmaceutical product.
Qualification and Validation
Ensuring the reliability and traceability of analytical results is paramount in the biopharmaceutical industry, particularly with early drug developers. Wheeler Bio's Analytical Development team is well-versed in qualification and validation processes and adhering to regulatory guidelines. Our qualification and validation services include:
We perform rigorous qualification studies to demonstrate the suitability and robustness of analytical methods. Through systematic evaluations, we establish method accuracy, precision, linearity, range, and specificity, providing you with confidence in the analytical results.
Analytical Method Validation
Our team conducts comprehensive method validation studies to confirm the accuracy, precision, specificity, and robustness of the developed analytical methods. This validation provides assurance that the methods are suitable for their intended use throughout the drug development process.
Wheeler Bio’s Process Development Lab is equipped with state-of-the-art analytical instruments that undergo thorough qualification processes. We validate equipment performance, ensuring accuracy, precision, and reliability in data generation.