Considerations for selecting your partner for Biologics Characterisation

Berangere Tissot, PhD, Director, Biochem Method Establishment & Biologics Characterisation, Eurofins Lancaster Laboratories, BerangereTissot@eurofinsUS.com

Throughout the course of product development, Biopharma companies need to consider multiple outsourcing plans, ranging from very early discovery support to late phase stability and release programmes. When selecting a provider for their Biologics characterisation needs, companies often consider reputation, expertise, and state-of-the-art instrumentation. At this stage of the product development, compliance generally ranks low on the priority list; however, this criterion should be carefully reconsidered.

Even if companies first encounter the need for characterisation at an early stage of their product development, in the pre-Investigational New Drug space, the application of these complex techniques is certainly not limited to pre-clinical/R&D phases. Characterisation methods are an integral part of the qualification or re-qualification of Reference Standards (RS) throughout the entire development cycle. These methods are included in RS management programmes, including post-approval ones. Since they are part of the application, data integrity requirements apply to any of the information provided to the agency for review and sustaining the use of a new RS lot.

Characterisation methods will also be required for any comparability study at each of the phases where critical changes are made. For example, if the major changes happen to be made after pivotal clinical trials or after commercial approval, the characterisation methods will be part of a critical data set. At this stage, the regulatory bodies are all in agreement: characterisation assays need to be demonstrated fit-for-purpose at a level equivalent to what is in essence
an R&D validation. The concepts applied to this demonstration of fitness are equivalent to the elements of a validation, including specificity, sensitivity and repeatability. Even though the regulatory agencies are not going to expect full cGMP compliance for these complex methods, it is also clear that these R&D assays cannot be performed by documenting them on the back of a napkin either - far from it.

Biopharma organisations might therefore be prudent to consider items such as data integrity, documentation management, and instrument performance management when choosing an outsourcing partner, which will guarantee that the investment they make in the very early stages of their product’s development is a robust and fruitful one. Thanks to its long history of providing a high level of regulatory compliance, including for complex assays, Eurofins Biopharma Product Testing is a trusted partner in biologics characterisation outsourcing.

For more information visit: www.eurofins.com/biopharma-services/product-testing/