Recently, progress has been made in the application of quality by design (QbD) to biopharmaceuticals, notably as a result of the US Food and Drug Administration’s (FDA) publication of process validation guidelines that integrated ICH principals.
But for biopharmaceutical manufacturers the additional complexity of using QbD can be an issue according to Kumar Dhanasekharan, director of process development for biologics at Cook Pharmica.
“It is a bit more complicated [to apply QbD to biopharmaceuticals] than it is to small molecules simply because the analytical methods we use for biologics are not able to characterise the molecule to the same extent.”
He explained that while for small molecules analytical methods can determine the structure and its entire makeup from an efficacy and safety perspective, this is just not possible for biologics.
“For a biologics the QbD depends upon the analytical methods we have. Obviously we can look at the amino acid sequence, the secondary and tertiary structure of the protein but you really never fully characterise the molecule.”