Virus clearance is essential for patient safety and regulatory confidence. Traditional broad worst-case testing can consume significant resources while offering limited insights into the influence of individual parameters. This White Paper presents how Quality by Design (QbD) provides a structured, evidence-based foundation to strengthen process understanding and develop proportionate, transparent control strategies aligned with ICH Q5A (R2).
Authored by Dr. Matthias Kron, Dr. Sven Schubert, and Lukas Döring, the paper outlines how risk-based parameter selection, mechanistic and statistical modeling, and digital tools support targeted study designs and robust scientific rationales across the virus‑clearance lifecycle.
In this White Paper, we delve into:
Why this matters
Enhanced process understanding builds a stronger foundation for designing proportionate studies, articulating clear scientific rationales, and supporting consistent regulatory communication. As development programs evolve, the approaches outlined in this White Paper offer a structured way to integrate new insights and maintain a high level of scientific rigor.
Download the White Paper now.
Rentschler Biopharma SE
Latika Bhonsle-Deeng, PhD
VP Global Marketing and Corporate Communications