Quality by Design
Our Quality by Design approach for your Drug Product development
Eurofins CDMO network of companies is pursuing a Quality By Design (QbD) approach in the development of new and innovative drug products for both small molecules and biologics. By implementing a QbD strategy, a better scientific understanding is obtained and unnecessary testing is eliminated, reducing the cost and increasing the overall speed of the development process.
Our solution oriented proposals:
- To ensure desired drug product quality, safety and efficacy, a Quality Target Product Profile (QTPP) is defined prior to formulation development
- The Critical Quality Attributes (CQA) of the drug product are determined
- A risk assessment is conducted to evaluate the impact of raw material attributes and process parameters on the CQA
- A design space is established describing the relation between the input (raw material attributes and process parameters) and the end product quality
Our key successful outcomes:
- Better scientific understanding of both drug product and manufacturing process is obtained
- Unnecessary testing is eliminated
- Optimization of budget & timelines
Want to develop your Drug Product with a Quality by Design approach ?
