Quality by Design
“We believe that quality by design is a revolutionary way of manufacturing that is of great importance for European markets,” states Andreas Schneider, director of global sales at Innovatis. Quality by design is the concept that quality issues cannot be tested into a product, but should be an integral property, built through a comprehensive scientific understanding of basic manufacturing principles. For global markets, implementing quality by design is the ideal way to standardize production to the rest of the bioprocess manufacturing world.
The FDA’s PAT initiative is related to quality by design. It addresses the concept of global harmonization with the goal of expediting the movement of pharmaceuticals to the marketplace through the application of consistent and predictable manufacturing processes. It is intended to foster innovation and drive efficiency in the pharmaceutical industry based on a set of scientific guidelines supporting originality and the regulatory implementation that will accommodate this inventiveness.
Innovatis’ new strategy is intended to overcome fear on the part of manufacturers that new and unique manufacturing and quality-assurance approaches will precipitate a regulatory gridlock.
The quality by design approach dictates precise process control. “For example, in the case of a cell-culture facility, the management and transfer of monitoring data is automated,” Schneider continues. “This allows the construction of a historical record, and adjustments are made for every successive run, maximizing efficiency and quality.”
The implementation of quality by design is especially germane at the international level, in regions where experience with highly demanding bioprocessing technology may be limited. The more a process is automated and the more the adjustments to that process are based on scientific data and experience, the easier it is to transfer a particular technology to any place in the world.
In order to implement quality by design, Innovatis has taken advantage of the BaychroMAT CellCount from Bayer Technology Services, a fully automated system capable of processing sterile samples directly from a bioreactor, according to the company.
As a quality by design automation platform, BaychroMAT integrates multiple biological and chemistry analyzers to enable the measurement of process parameters.
Another Innovatis product, the Cedex automated cell analyzer, is incorporated as a tool in quality by design. It determines cell concentration and viability during the course of cell cultivation and fermentation processes.
According to Schneider, implementation of quality by design will be more and more essential in the future, most specifically with the rise of individualized therapies and drugs. Relying on continuous improvements based on real-time data, such a strategy is tied into adaptability. The bottom line is that quality by design principles can guide a manufacturing process, reducing time-to-market through approval and release in real time from regulatory authorities.
Where Do We Go From Here?
As more and more clinical data is accumulated on the properties of anticancer antibodies, trenchant observations have been made that may lead to more effective and targeted treatment with these agents.
For example, patients possess genetic polymorphisms for the Fc receptor that affect the ability of the antibodies to mobilize ADCC. In the future, patients could be profiled and those for whom the therapy would not be successful can be directed to other treatments.
Moreover, it should be possible to engineer antibodies that can overcome the genetic recalcitrance of nonresponding patients. Management strategies such as quality by design, with its constant monitoring and feedback, should accelerate the discovery process and hasten the development of more effective therapies.