SP Scientific conducted a video interview with Dr Kevin Ward of Biopharma Process Systems Ltd to discuss how expanding design space increases the probability of executing a successful lyophilization cycle.
Image credit: SP Scientific
The Quality by Design (QbD) approach to producing lyophilized products is increasingly being adopted in the pharmaceutical and biopharmaceutical industries. In the manufacturing environment, this translates into leveraging a sound understanding of operations to design a manufacturing process with defined multivariate parameter ranges that produce acceptable product quality attributes. In the QbD approach, this multidimensional combination and interaction of input variables, equipment limits and product limits can be mapped to create the viable design space for lyophilization of a given formulation.
Dr Ward discusses how operating a lyophilization cycle within the design space will result in a product meeting a predefined quality. Having a larger design space, or parameters in which to work, increases the probability of executing a successful cycle, even in the face of potential problems, such as process excursion due to unplanned power loss.
In addition, Dr Ward explains that by establishing an expanded design space, users can develop a more flexible approach in development and manufacturing process and it is then easier to implement continuous process improvement and maintain product integrity within the boundaries of that design space.