Conveners
Statistics in Pharma / Healthcare: Pharmaceutical Process Modelling and Manufacturing Analytics
- Marina Vives-Mestres (Universitat de Girona)
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Chellafe Ensoy-Musoro (Johnson & Johnson)9/7/26, 10:55 AMStatistics 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...
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Olympia Tumolva (Johnson & Johnson)9/7/26, 11:15 AMStatistics 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...
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Marco Mariti (GSK)9/7/26, 11:35 AMStatistics in Pharma / Healthcare
A key challenge for mRNA vaccine and medicines development is represented by mRNA degradation under normal refrigerated storage condition (2-8°C). Product evolution over time is primarily driven by mRNA Integrity degradation, occurring mainly through chemical hydrolysis.
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mRNA molecules are known to be particularly susceptible to hydrolysis under alkaline conditions, where degradation via...