Where Next for QbD?
Many speakers at the QbD forum agreed that the major driver of implementing a full QbD strategy is to gain a deeper process understanding and in doing so produce more robust and safer biologics. This means that the use of single-use facilities where automation and online measurement is much more prevalent is going to be the trend going forward. Becker states: “A major aspect is product safety, which is primarily affected by the robustness and flexibility of the processes developed. This is precisely where the combination of innovative, robust process analytics, model-predictive control, and flexible automation is going to play a central role.”
Amit Banerjee, Ph.D., research fellow global biologics at Pfizer says, “For process understanding of the cell culture we have to have good scaledown models, which show equivalence at 2 L, pilot scale, and 12,000 L.” Dr. Rathore adds: “I predict all companies developing biologicals will be using scaledown models and MVDA in the next decade.”
According to Schneider the biopharm industry is lagging way behind other industries and needs the right data management in place. “QbD has a very strong IT component, which means that data quality matters and the IT stakeholders have to be involved,” he says. “Everyone fears the IT guys but they shouldn’t; if they are involved at the beginning it may add delay, but it will speed up the process in the end if they are fully engaged in the project.”
“Full QbD starts from a comprehensive control strategy of your raw materials and cell banks,” Banerjee added. “This is time consuming to do and implement, and perhaps leads to the proverbial pot of gold in the end for those companies that can do it well.”