- Firstly, an Initial risk assessment based on quality target product profile and prior knowledge was performed to anticipate the risks linked to process development and its scale-up to industrial scale. An action plan was proposed to mitigate the identified risks.
- Secondly, basic data that are required for process understanding were acquired at lab scale
- Thirdly, process development was carried out at pilot scale to define the design space were the product will be produced with the appropriate attributes. The process was designed to meet two key performance indicators: high Process yield and compliance to environment hygiene and safety regulations.
- Finally, process fine tuning was performed at intended scale for industrialization
Mostafa Nakach, Head of Pharmaceutical engineering-Paris, Sanofi