Considerations for Selecting your Partner for Biologics Characterization

by Berangere Tissot, PhD, Director, Biochem Method Establishment & Biologics Characterization

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 programs. When selecting a vendor for their Biologics characterization needs, companies often consider the following criteria: reputation, expertise, state-of-the-art instrumentation, ability to consult and provide support for the data interpretation. 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 characterization at an early stage of their product development, in the pre-IND space, the application of these complex techniques is certainly not limited to pre-clinical/R&D phases.

Characterization methods are an integral part of the qualification or requalification of Reference Standards (RS) throughout the entire development cycle. These methods are included in RS management programs, including Considerations for Selecting your Partner for Biologics Characterization post-approval ones. The results generated using these complex methods may be reported in the Supportive Data Section. 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.

Characterization methods will also be required for any comparability study at each of the phases where critical changes are made. Platform methods and head-to-head comparisons could be acceptable for an early phase minor change, but this strategy will not be sufficient for a more critical change or a later stage change. The guidelines enforce fit-for-purpose demonstration for these complex assays as they are now utilized outside of their typical “one-off characterization” context. The later the changes are made within the product development life cycle, the more stringent are the requirements around the “qualification” of the characterization assays. For example, if the major changes happen to be made after pivotal clinical trials or after commercial approval, the characterization methods will be part of a critical data set to be provided for regulators to review. At this stage, the regulatory bodies are all in agreement: not only are the characterization assays an essential part of the comparability exercise, but they now 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 performing these R&D assays cannot be performed by documenting them on the back of a napkin either - far from it.

Over the past decades, the FDA and other regulatory agencies around the world have extended their overview of the product development lifecycle to the early phases, leading to a more thorough evaluation of R&D laboratories. Indeed, the FDA would expect early phase and characterization results to sustain their scrutiny, should the need for this data to be used or reviewed by regulatory bodies at a later stage during the product’s approval process.

Biopharma organizations 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 their long history of providing a high level of regulatory compliance, including for complex assays, Eurofins Biopharm Services can be a trusted partner in biologics characterization outsourcing.