Review Article

Early Implementation of QbD in Biopharmaceutical Development: A Practical Example

Table 1

QTPP, CQA, and design criteria derived for case study 1. In this particular case, previously known product shortcomings in terms of stability have been used to focus criteria around quality requirements for a hypothetical final product.

QTPPCQADesign criteria (Developability)

Optimise manufacturing and development costs
Safety to patient
Aggregation
Productivity
Increase product stability
Reduce aggregation
Maintain/increase product titre

Adequate product efficacyBiological activityRetain affinity to target within acceptable levels