Validation Is Not Verification: Precise Terminology and Scientific Methods in Bioprocess Modeling

Jens Smiatek; Alexander Jung; Erich Bluhmki

doi:10.1016/j.tibtech.2021.04.003

Validation Is Not Verification: Precise Terminology and Scientific Methods in Bioprocess Modeling

Trends Biotechnol. 2021 Nov;39(11):1117-1119. doi: 10.1016/j.tibtech.2021.04.003. Epub 2021 Apr 24.

Authors

Jens Smiatek¹, Alexander Jung², Erich Bluhmki³

Affiliations

¹ Institute for Computational Physics, University of Stuttgart, D-70569 Stuttgart, Germany; Digitalization Development Biologicals CMC, Boehringer Ingelheim Pharma GmbH & Co. KG, D-88397 Biberach (Riss), Germany. Electronic address: jens.smiatek@boehringer-ingelheim.com.
² Digitalization Development Biologicals CMC, Boehringer Ingelheim Pharma GmbH & Co. KG, D-88397 Biberach (Riss), Germany.
³ Analytical Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, D-88397 Biberach (Riss), Germany; University of Applied Sciences Biberach, D-88400 Biberach (Riss), Germany.

PMID: 33906798
DOI: 10.1016/j.tibtech.2021.04.003

Abstract

Advanced statistical approaches and new modeling procedures for biopharmaceutical development and manufacturing have received increasing attention. With this forum article, we would like to highlight the need for a consistent terminology and the necessity for appropriate model validation strategies.

Keywords: bioprocess modeling and simulation; model validation; scientific practice; terminology; verification.