Analytical Method Transfer (AMT) must be reported in adequate detail to allow assay reproduction and obtain data within acceptance criteria as per the US FDA’s relevant guidelines. Typically, Method Transfer is completed ahead of assay transition to a new bioanalytical facility. Among other reasons, this could be necessitated by the requirement to perform the sponsor assay in more stringent conditions, such as GMP/GLP/GCLP. NorthEast BioLab analysts are proficient in interpreting Analytical Method Transfer reports for GLP/GCLP Assay set up at our facility, as well as preparing detailed documentation for shifting sponsor assay to other GMP facilities and locations.
Analytical method transfer is a critical step in drug development that’s quite frequently encountered by biotech and pharma R&D personnel. Broadly, it is a documentation process that enables one laboratory (receiving laboratory) to set up and utilize an analytical test procedure that originated in another laboratory (sending laboratory). Method transfer ensures that the receiving lab has all pertinent method details, such as sample preparation approach, favorable equipment settings, and desired atmospheric conditions to reproduce the analytical test procedure systematically.
Proper method transfer minimizes unnecessary trial and error given the receiving laboratory takes method setup guidance from another lab successful with that method already. Often, the step takes place before the method gets validated at the sending lab given the receiving lab typically will have to validate the method anyway for generating data worthy of regulatory submission. Naturally, it is more resource, time, and cost effective to do the method transfer prior to validation. Method transfers can occur between different labs at the same testing site, or between different sites of the same company, or even between different companies and labs depending on a variety of scientific, financial, and human resources related factors. The requirements for the transfer such as extent of documentation, however, change based on the lifecycle stage of the method.
It’s important to have specific standard operating procedures in place to ensure the analytical method transfer is comprehensive and reliable. For instance, a detailed and well-written method protocol should be shared before the transfer process begins. Ideally, the sending lab should make its experts accessible to the receiving lab before the transfer as well. Finally, the receiving lab should test-run the procedure and flag potential issues for clarification before the transfer is completed.
Our projects with NorthEast BioLab include method development, stability studies, cross-validation of other labs, support for investigator-sponsored studies, and Clinical Phase I – IV studies. They have considerably exceeded our expectations time and again.
NorthEast BioLab provided critical insight into data analysis, and are compliant with industry best practices and regulatory standards. We would certainly recommend them and look forward to working together in the future.
NorthEast Biolab truly goes that extra mile to make the collaboration successful, and I will continue to enjoy very productive interactions with them in the future. The integrity of the staff is as refreshing as their willingness to provide ingenious scientific input and high-quality data.
Our latest study together was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers needed swift analysis. This study, same as all other bioanalytical studies with NorthEast BioLab, was completed with very high quality and reporting standard and incredible responsiveness.
NorthEast Biolab is by far the most responsive and thorough bioanalysis service provider. They work closely with the client to provide the most efficient and cost-effective approach to get the job done.
We have worked with NorthEast Biolab on several programs and have found them to be professional, collaborative, and responsive. As a small company, our vendors are key members of our project teams. The scientists at NorthEast Biolab are technical experts, who produce high-quality data, on-time, and on-budget.
At NorthEast BioLab, we primarily focus on method transfer for pharmaceutical products or drugs in development. We specialize in providing bioanalytical methods and services for small molecules. These small, chemically manufactured molecules are classic active substances and continue to make up over 90 percent of the drugs in the market today. We guide our clients through key phases of the drug development process providing analytical method transfers during all phases of drug discovery and development
At NorthEast BioLab, we conduct method transfer/cross-validation using either quality controls or incurred study samples or both.
Our method transfer procedures rigorously evaluate the following parameters. Of course, this is just an indicative list that’s subject to shift focus significantly depending on the analyte at hand.
The parameters that are required in any method transfer depends on the desired results of the method transfer. The method transfer protocol defines the objectives, materials, and analytical procedures that need to be transferred and is the defining guideline for the entire process.
Bioanalysis is an essential tool in drug discovery and development for determining the concentration of drugs and their metabolites as well as various pharmacodynamics biomarkers in biological fluids. In these analyses, scientists use developed an….
Across the world, drug development companies are outsourcing bioanalysis to Contract Research Organisations. However, given the time-sensitive nature of drug development, finding the right partner is important. At NorthEast BioLab, we have over 15 years of experience in analytical method development, validation, and transfer. We understand that optimizing your costs and resources is critical during the drug development process and we do everything we can to help you get there.
We work with clients to use the type of analytical method transfer that is suited to their situation. We bring together our core strengths, operational excellence, regulatory expertise, and scientific experience to help you reach your goals faster.
