Optimising cell-based bioassays via integrated design of experiments (ixDoE) - A practical guide

Area of Science:

• Biopharmaceutical development
• Process optimization
• Cell-based bioassays

Background:

• Design of Experiments (DoE) is superior to One Factor at a Time for process optimization.
• DoE adoption is limited in cell-based bioassay development due to perceived complexity and resource demands.
• Complex interactions are common in bioassay development, necessitating advanced optimization strategies.

Purpose of the Study:

• To introduce an integrated Design of Experiments (iDoE) approach for efficient bioassay development.
• To address the reluctance of biopharmaceutical manufacturers to adopt DoE by simplifying its application.
• To optimize resources and time in bioassay development using a novel iDoE strategy.

Main Methods:

• Development of an integrated Design of Experiments (iDoE) methodology.
• Application of a suitable statistical analysis strategy for iDoE.
• Demonstration of iDoE in a typical bioassay development workflow.

Main Results:

• The iDoE approach enables necessary statistical inference from a single experimental set.
• This contrasts with standard practices requiring 3 to 4 separate DoEs.
• The iDoE method significantly optimizes resources and time in bioassay development.

Conclusions:

• The integrated Design of Experiments (iDoE) offers a practical and efficient alternative for bioassay development.
• iDoE reduces the perceived costs, efforts, and complexity associated with traditional DoE methods.
• This approach serves as a guide for implementing advanced statistical strategies in biopharmaceutical research and industry.