Choosing the right assay at the right time for biosimilar development

27th March 2017

Category: Bioanalytical / Biosimilars

Tags: , ,

By: Dr Terry Gray, Field Marketing Manager,

Part Three

As highlighted in our previous blog articles, cost & throughput are important contributing factors to consider when developing a biosimilar. Another factor to consider is the choice of assay that will be used at each stage of the biosimilar product life cycle.

There are two competing areas which drive the decision making process for assay selection

  • The desire to have as sensitive a method as possible, one which is capable of identifying small differences
  • The need to have an assay which represents the complexity of the in vivo environment and is therefore more predictive of clinical efficacy

However, one assay methodology cannot completely fulfil both these criteria, so scientists should be prepared to use a sequential approach using orthogonal methods. This will allow for a data package to be built up one step at a time to better demonstrate biosimilarity.

Ultimately, it will depend on the stage of biosimilar development as this dictates the importance of each of these considerations, therefore choosing the right assay at the right time has the utmost importance.

By implementing the most sensitive methods at the earliest stages of biosimilar development, manufacturers have the ability to make an informed decision and take optimal clones forward, driving efficiencies in both money and time.

To read our conclusions of this blog series, download our whitepaper here.

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