WEBINAR

End-to-end modelling from API to finished Tablet

By developing mechanistic models and customizing some of them at each step of the manufacturing process of a drug product at laboratory scale, we propose an interconnected model using gPROMS software which supports the process scale-up linked to critical quality attributes of the final tablet drug product. Simulations performed help to predict operating domain and impact of variation of input parameters on the Critical Quality Attributes. We achieved to secure first clinical batch at pilot scale without any technical batch and saved time, resources, and material.

What this webinar covers

• gPROMS targeted end to end model
• Drug Product dry granulation manufacturing process
• Unit operations considered:
  • Dry granulation and Milling process
  • Tableting process
  • QC dissolution

Presenter(s)

Nicolas Sanchez, Pharmaceutical engineering team – Synthetics platform, Sanofi

Nicolas started his career at Sanofi in 2000 as a chemist. He worked first in development plants and then in lab research programs. Nicolas graduated with an MSc “Information and Communication Technology for Health” in 2014. He started working as a pharmaceutical engineer in drug product development in the area of powder characterization in 2016. Now, he uses mathematical models and assesses powder properties, supporting drug product development teams to develop adequate processes. Nicolas leads the transfer process from Lab, to Pilot, up to industrial scale. In this webinar, Nicolas will present how to secure the transfer of a new formula and process developed at lab scale using modelling in gPROMS.