How do you transfer analytical methods from R&D to QC or CRO?

In some case if you are performing one sided activity one can add Specificity, Linearity, Spiked MP/IP at 100% level, LOQ precision and called it as method verification instead method transfer in relation of original method validation.

Regarding the tech transfer process, it would be highly beneficial to involve individuals who possess both hands-on experience and expertise in assay development. Historically, we have observed instances where individuals managing these critical tasks needed a comprehensive understanding of both the scientific intricacies and the nuances of tech transfer. Involving subject matter experts in this process could significantly enhance the efficiency and effectiveness of the tech transfer.

If you cant explain it simply, you don't understand it well enough. Same principle applies when initiating a method transfer between labs/sites/departments. During the development stage, provide the drafted method to a colleague for testing, if the results from the analysis doesn't replicate, then thoroughly inspect every variable in the drafted method. This will fill any potential gap in the translation of method. Something which is obvious to an expert may not be a familiar topic to an occasional user. Draft the method with simple yet concrete vocabulary and avoid ambiguity. Needless to say, perform a thorough review of CQAs and even after the transfer is complete, ask for feedback and implement them.

I often have to perform a one-sided non-participatory transfer because the originating laboratory cannot participate. In this case, I perform accuracy and precision, as well as confirming LOD/LOQ as necessary. It is also important to have a well-defined protocol in this instance, as well as pre-approved acceptance criteria.

Some additional points to consider: 1. Ensure that the samples used during method development and method validation are similar or same and produced using the same manufacturing process. 2. Methods that require demonstrating sample dilution linearity may encounter deviations/ non-conformance from the listed method validation protocol acceptance criteria if minor changes to manufacturing process have resulted in a shift in the amount of residual impurities, owing to which sample dilution assays working during method development may not work while validating the method. 3. QC must critically review method validation protocols, listed acceptance criteria, and the method used for validation (after the training on the method is complete).

Another frequently overlooked challenge involves the need for clear and efficient communication. In addition to fostering collaboration between the technical teams from both the sending and receiving units, the sponsor's project team must allocate time to facilitate a smooth technology transfer. They can play a vital role by offering guided reviews of crucial documents, ensuring that valuable information is kept secret in the transfer process. The active engagement of project managers, who dedicate time to preparing for meetings, conduct structured reviews of batch records, and issue early alerts, is pivotal in ensuring a seamless technology transfer.

Communication is key. I routinely work with CROs that are struggling with reproducing acceptable data after a method transfer. When working with HPLC, it's not uncommon for the instrument delay volumes to be significantly different between the two labs. Often times the initial troubleshooting questions are "what instruments are you using?" and "what instruments did the R&D lab use?" Far too often the lab receiving the method does not know what instrument models and/or configurations were actually used for developing the method.

Establishing effective communication with the receiving laboratory is essential for the successful transfer of analytical methods. Understanding the infrastructure and personnel needs of the receiving labs and making contact with them well before the actual transfer is crucial. Both the procedure and the analysts involved are equally important in analytical science. Well-written, detailed, and easy-to-understand procedures greatly aid in the training process. It's vital to ensure that the receiving lab personnel are thoroughly guided through the process and that all their questions are answered as they shadow. Maintaining constant communication while keeping all stakeholders aligned and clearly informed will ensure a successful transfer.

communication is certainly fundamental, there are research studies that require transparency between both parties, without letting professionalism interfere in decisions.

First, update all relevant documents to reflect any changes made during the transfer. This includes revising the analytical method procedure, validation report, standard operating procedures (SOPs), specifications, and the certificate of analysis (COA). again, it’s important to train the receiving lab staff on the updated methods and documents to ensure they understand the changes. Using digital tools can help streamline this process, making it easier to track updates and maintain compliance with regulatory guidelines. By implementing these changes effectively, you ensure the method's reliability and quality, which is crucial for accurate testing and results in quality control.

A verified method can be transferred to QC/CRO with strict restrictions to variability. It may be comparitive testing, Re/co validation of method, in any case transfer of method from R&D to strict GMP restricted labs need more care. A clearily ordered and structured method development report must be followed up. This has to be reviewed by the Reciving laboratories and other cross functional teams to identify the bias. In this current digital era, recorded files/ images for the procedures are more helpful to reduce the chanes of errors and during investigations. Criticality of the methods to be verified by the originating laboratory and recieving laboratory and to be discussed.

Successful analytical tech transfer is critically dependent on proper planning, communication, and training. Groups MUST be willing to provide direct hands-on, on-site support and training; simply emailing a method protocol, associated development data, and expecting that a lab is able to perform the method to specification is a great way to ensure failure. Intra- or Inter-company transfers can be synergized during developement activities. Having QC/CRO SME's working hand-in-hand with R&D/AD ops can eliminate nearly all misinterpretation, and ensure trainability within QC or the CRO. Tech transfer is a resource intensive process - lower resource investment upfront will guarantee a higher cost to remediate down the road.

Some commonly anticipated method transfer challenges include -Not allowing enough time for QC to familiarize themselves with the method prior to transfer -Merely complying with the transfer acceptance criteria, leading to post-transfer issues. Implementing an early mitigation strategy during method qualification in AD can smoothen the transfer process. Having QC personnel perform intermediate precision in AD incentivizes the method owner to train QC effectively, as AD still holds responsibility for completing the qualification. We implemented this strategy in my last company, resolving most transfer issues during qualification. Having experienced both ends of the method transfer process, this was the most seamless transfer in my career.

After successful development and validation of any analytical method in ARD (Analytical Reasearch and Development), the respective documents, samples (Standards and References) and instruments (Columns for example) must be sent to the respective site QC. Based on a protocol, analytic method transfer will be initiated in the presence of both Method developer and QC analyst. Once the method is ensured to be Repeatable and Reproducible, the results will be recorded and reported against the protocol. Upon successful Method transfer, same will be validated at the site QC with required guidelines and site specific SOPs. Areas to be considered: Columns, Standards, References and Systems Make

Analytical chemists in R&D and QC/CRO share skills but differ in method development approaches. R&D methods are swiftly tailored for specific experiments with minimal validation, while QC/CRO labs require rigorous validation for repeated use under strict conditions. Anticipate potential transfers during development, optimizing and validating with the end-user in mind. Seamless communication and training bridge the gap between R&D and QC/CRO teams, ensuring reliable methods in diverse settings. Consider potential transfers during method development to prevent issues in validation by QC/CRO.

R&D, QC and CRO each have their own languages, and within each group, their main objectives/goals are clear and obvious. The first point must be wisely used to show how each group’s objectives work together. For sample, food safety/quality requires accurate testing be done in a timely fashion so decisions can be made confidently and “in time to be effective” or in an emergency situation, life saving. All groups understanding the importance of the big goals allows all steps to contribute.