ENBIS-26 Conference

Session

Statistics in Pharma / Healthcare: Pharmaceutical Process Modelling and Manufacturing Analytics

Sep 7, 2026, 10:55 AM

Centro Didattico Morgagni

Conveners

Statistics in Pharma / Healthcare: Pharmaceutical Process Modelling and Manufacturing Analytics

• Marina Vives-Mestres

25. Estimating Stabilization Time in Continuous Manufacturing

Chellafe Ensoy-Musoro (Johnson & Johnson)

9/7/26, 10:55 AM

Statistics in Pharma / Healthcare

This work develops a statistical framework to estimate stabilization time for core tablet batches produced by continuous roller compaction. Using simulated data from multiple production runs of a representative product, the project focuses on characterizing concentration stability during start-up and identifying an optimal start-up duration to guarantee product quality and consistency. The...

55. Incorporating Factor Variability into Risk Estimation in Pharmaceutical Manufacturing

Olympia Tumolva (Johnson & Johnson)

9/7/26, 11:15 AM

Statistics in Pharma / Healthcare

In pharmaceutical manufacturing, process optimization and control are critical for ensuring consistent drug product quality and regulatory compliance. In real-world applications, certain study factors are treated as fixed and maintained constant to standardize production conditions. However, it is sometimes inevitable for other factors to exhibit variability, introducing uncertainties that can...