Supporting Process Analytical Technology in Pharmaceutical Manufacturing With Lean Chemometrics

The calibration burden of developing chemometric techniques to extract relevant information from spectral data is a barrier to spectroscopic process analytical technology (PAT) adoption in the pharmaceutical industry.Calibration burden refers to the time, material, and financial cost involved with generating representative calibration samples and corresponding reference data.The primary driver of calibration burden in precommercial pharmaceutical PAT applications is the high expense and limited availability of active pharmaceutical ingredients, particularly during early drug development stages.The concept of lean chemometrics is introduced to reduce calibration burden by leveraging multivariate data analysis methods that incorporate time-saving, material-sparing, and cost-cutting strategies.This article provides a definition and scope of lean chemometrics alongside a discussion on how to integrate these techniques with spectroscopic PAT to enable fit-for-purpose applications in pharmaceutical manufacturing.There are many chemometric techniques that meet the definition of lean chemometrics and have been demonstrated within the scientific literature to reduce calibration burden for spectroscopic PAT deployment.By formalizing lean chemometrics, the authors hope to raise awareness of historic methods and encourage the development of new lean chemometric techniques to overcome the notable challenge of the calibration burden.This is done with the goal of easing and expanding spectroscopic PAT adoption in the pharmaceutical industry and related sectors.