The FDA tells us that quality by design is understanding the manufacturing process and identifying the key steps for obtaining and assuring a pre-defined product quality1. A recent survey conducted in conjunction with BioProcess International2 revealed a disconnect between the perceived importance of this initiative and the extent of its implementation across the biopharmaceutical industry.
In part one of our focus on QbD, we ask our experts to comment…
The large biotech companies have been working with the FDA probably several years to determine how best to apply the core QbD principles FDA articulated for small molecules to the unique challenges and differences with protein molecules.
I think the FDA overall concept with QbD is that they want to see
One of the main underlying principles of QbD development is to be able to determine how process parameters can affect the quality attributes of a molecule, and to understand how these quality attributes in turn affect the clinical outcome, meaning the safety and efficacy profile of the product. The QbD process development