QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process. This whitepaper looks at how biomanufacturing organizations can achieve continuous quality verification using real-time data. We focus on simple, practical examples of how top-tier biomanufacturers have implemented QbD.
In this whitepaper you will learn about:
- The role of QbD and ICH Q8-Q10 in improving both process development and manufacturing systems
- An analysis of toolsets and their role in 'seeing' variability and using it to inform quality
- Practical approaches, such as statistical process control, and pitfalls associated with them
- More advanced data mining techniques and how they can assist QbD initiatives
Please register to download this free whitepaper at http://www.bio-g.com/whitepapers/download/quality-by-design-in-biomanufacturing.