Method Transfer

Assay Method Transfer: Streamline Your Process with Our Expertise

Method transfer in the pharmaceutical industry is a crucial element of quality control for the drug development process. It serves as a type of fail-safe to ensure that the methods being performed in one laboratory produce comparable results when duplicating the procedure in another.

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Leverage BioAgilytix’s expertise in method transfers

At BioAgilytix, our staff is experienced with transferring assays from sponsors and other vendors for the purpose of updating, optimizing, and/or maximizing throughput of the method. Additionally, BioAgilytix has the ability and experience to successfully transfer assays internally between sites to meet global trial needs or for scaling up our testing footprint to increase capacity. 

The goal in a successful method transfer should be to reduce the number of variables in the lab which could affect the quality of the final product. These methods need to be taken from the primary lab and transcribed into approved documents for testing at the final lab(s). Successful method transfer, an integral step in pharmaceutical product development and testing, depends on many variables ranging from system characteristics and instrument configuration to method robustness and operator-to-operator variability.  

Additionally, data integrity is a main focus for streamlining these processes. The transfer of assays from one lab to another creates the risk of inconsistent data across the labs. Our teams have worked with many external laboratory groups and understand these key considerations for implementing successful transfers. We can leverage this experience to best assess assay comparability and create plans to mitigate risks.

Strategic approaches for successful method transfers 

BioAgilytix has multiple layers of procedures and practices in place to support successful method transfers both internally and externally.  We focus on ensuring the highest level of control and optimal laboratory performance during the transfer process through: 

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Globally harmonized SOPs and adherence to industry best practices for both external and internal assay transfers  

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A network of scientists who work together and maintain effective communication across sites 

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Dedicated program management resources to coordinate cross-site efforts and facilitate information flow 

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Platform redundancy across sites and rigid equipment management programs to ensure comparable instrument performance 

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The benefits of partnering with a global organization 

With locations in North America, Europe, and APAC, BioAgilytix is well positioned to provide global clinical trial support. We have invested in building redundancy in our capabilities at all of our sites and standardizing our internal assay transfer procedures. This allows us to offer multiple labs that are capable of supporting assays as needed. With our network of 600+ scientists and laboratories boasting over 100 years of combined experience with bioanalytical support, BioAgilytix provides the depth of knowledge and experience to meet all of your assay transfer needs.