Post by Rentschler Biopharma

Is your virus clearance strategy leveraging evidence‑based design? Quality by Design offers a structured, science‑driven way to deepen process understanding in virus clearance and align development strategies with ICH Q5A (R2).    Our latest white paper, “Quality by Design. Understanding and Securing Virus Clearance,” provides practical insights from our experts Dr. Matthias Kron, Dr. Sven Schubert and Lukas Döring Key topics covered include:  ▫️ Criteria for identifying truly critical CPPs and CMAs  ▫️ Mechanistic and statistical modeling, incl. in‑silico simulations  ▫️ Evidence‑based validation concepts under ICH Q5A (R2)  ▫️ QbD‑aligned study design across the virus‑clearance lifecycle  ▫️ Use of analytical and digital tools to support transparent scientific rationales  Download the white paper now: https://lnkd.in/e7ypRQVj #RentschlerBiopharma #CDMO #ReliabilityYouCanTrust #CaseStudy #WhitePaper