State of the Art Analytics

Highly sensitive methods are essential to analytical understanding—the cornerstone of demonstrating biosimilarity.

In biosimilar development, the analytical data is the foundational component to demonstrating the level of similarity a biosimilar has to a reference product.1

Product quality is critical to the efficacy, safety, and immunogenicity of all medicines and is assessed at the earliest stage of development and continually through the medicine’s commercial production. However, it is not enough to just test the product qualitythe methods used for these tests must be sufficiently sensitive and have a high enough resolution to ensure that differences can be detected if they exist. 

Different companies will take different approaches to analytical testing. The detail of information developed about the product is impacted both by how the test is performed and the actual tests used.

Analytical techniques vary in their quality just as a photograph can vary in quality. Two of the measures that scientists often use to describe the quality of a method are resolution and sensitivity. Just as low resolution in a photograph can hide important details, low resolution in an analytical method can mask differences in products. 

On this page, there are two otherwise identical photographs with different resolutions and two sets of hypothetical analogs representing two attributes in the same proportion but with different resolution. 




In these examples, information about the succulent plant is less apparent in the photograph with low resolution, just as information about the smaller peak, which represents a product attribute, is lost in the example with low resolution. This would be particularly important when the smaller peak represents an attribute that impacts how the drug works. Similarly, sensitivity is like contrast: the more sensitive a method is, the better it is capable of detecting a small difference.


Reference:

  1. Conner J, Wuchterl D, Lopez M, et al. The biomanufacturing of biotechnology products. In: Shimasaki C, ed. Biotechnology Entrepreneurship: Starting, Managing, and Leading Biotech Companies. Waltham, MA: Academic Press; 2014:351-385.