Impacting Scientific Research
The Smithers Method Development team's experience allows for the the advancement and refinement of scientific research methodologies, improving the reliability and reproducibility in the areas of pharmacokinetics (PK), anti-drug antibodies (ADA), neutralizing antibodies (Nab), biomarkers, enzymatic assays, and molecular assays.
Our team uses a variety of platforms including ELISA, MSD, Singulex, Gyrolab, Quanterix, AlphaLISA, and ELISPOT to ensure accurate, high-quality results.
Method Development
Our approach ensures that every method we develop is optimized for your specific research needs, whether for a new assay or improving an existing one.
Method Feasibility & Design
We carefully assess the feasibility of new methods and design protocols that align with your project objectives to create a methodology that fits the unique characteristics of your study.
Optimization & Refinement
Our optimization process ensures that assays are accurate, reproducible, and efficient. Our goals is to develop methods that are scientifically sound and meet your operational requirements.
Method Transfer & Implementation & Refinement
We provide seamless transfer to your operations team ensuring smooth integration into your workflows. Our experts will provide training and troubleshooting support to guarantee your team can confidently implement the method.
Drug Specific Assays
• Antibody pair selection
• Checkerboard
• Assay condition optimization
• Method feasibility
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Method Validation
Validation is an essential step to ensure your methods are reliable. At Smithers, we employ scientifically validated techniques and equipment to confirm the accuracy, precision, and reproducibility of your methods.
Analytical Performance Testing
We perform comprehensive testing to confirm key performance metrics such as accuracy, sensitivity, specificity, and precision to ensure your methods meet regulatory standards.
Regulatory Compliance
Our team is well versed in global regulatory requirements (FDA, EMA, ICH, etc.). We ensure that all validated methods meet these standards.
Cross-Platform Validation
For methods that require validation across multiple platforms or instruments, we offer cross-validation to ensure consistent and reliable results.
Drug Specific Assays
• ISR, Parallelism
• Bridging PK method from multiple platforms
• Cross-validation between laboratories
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Frequently Asked Questions (FAQs)
What is the difference between method development and method validation?
- Method development involves creating or improving an analytical method to meet specific project needs, focusing on design, optimization, and reproducibility. Method validation confirms that the developed method consistently meets performance standards, ensuring it’s accurate, reliable, and compliant with regulatory guidelines.
What are the key factors to consider when developing a new analytical method?
- Purpose & Scope, Sample Matrix, Regulatory Requirements, Sensitivity & Specificity, and Reproducibility. These elements ensure the method meets your scientific & operational needs.
How do you ensure your methods comply with global regulatory standards?
- At Smithers, we follow global standards such as FDA, EMA, and ICH guidelines throughout the development and validation process. Our team ensures that all methods meet regulatory requirements, providing the necessary documentation and support for submissions.