🔍 Quality-by-design (QbD) is a principle that focuses on building product quality into manufacturing processes from the early stages.
💡 Innovative methods and digital technologies can capture and model process data in real-time, making QbD-based process development less complex and costly.
💰 Digital solutions can also decrease commercial manufacturing costs and eliminate the need for extensive regulator notifications when making minor adjustments.
🌍 International drug companies would benefit greatly from the combination of QbD and digital technologies.
🔬 Analytical technology and digital twins are crucial for evaluating, predicting, and modeling QbD processes.
🚀 The industry is looking forward to new technologies that can support the full QbD approach.
👥 By embracing digital technology, pharmaceutical companies can fully embrace QbD and reap its numerous benefits.
Introduction:
The article discusses the benefits of using digital bioprocessing technologies in drug manufacturing to improve product quality and reduce costs. It focuses on the application of quality-by-design (QbD) principles in the development of manufacturing processes and how digital technologies can aid in this process.
- QbD is a regulatory approach that emphasizes building product quality into manufacturing steps rather than relying on testing after process development is completed.
- However, developing commercial-scale production processes with QbD remains challenging and expensive.
- Digital bioprocessing technologies can capture, transmit, and model process data in real-time, reducing the complexity and cost of QbD-based process development.
- A better understanding of biopharmaceutical processes using computer technologies and analytical tools can aid in the development of digital twins, which can support the full QbD approach.
- The combination of QbD and digital technologies can also decrease manufacturing costs by allowing minor adjustments without extensive regulatory approval.
Conclusion:
Utilizing digital bioprocessing technologies can help pharmaceutical manufacturers improve product quality, reduce costs, and fully embrace the principles of quality-by-design. The development of digital twins and the integration of real-time process data can streamline the process development and regulatory approval processes. This combination of QbD and digital technologies offers significant benefits for the industry and paves the way for more efficient and cost-effective drug manufacturing.
