Author: Graham McGowan, Ph.D., Senior Manager, CMC & Regulatory Services at Eurofins CDMO Alphora Inc.
This highlight article is not intended to provide an in-depth statistical view of the use of multivariate tools as one component of API/Drug Substance development, but to illustrate approachable steps to adopt the methodology as one tool in the development tool box, alongside more traditional approaches.
Case study examples are provided to highlight the approachability and potential utility of the approach, from early-phase development, to long-term manufacture.
