Survey Results: The Use of DoE in the Pharmaceutical Industry - Part I

With the ICH guidelines ICH Q8, Q11, Q14 and the revision of ICH Q2, the subject of developing processes and analysis methods has gained greater importance than in the past. One of the methods referred to as helpful here is Design of Experiments (DoE). A chapter of the European Pharmacopoeia also deals with this topic. Is DoE already being used in the pharmaceutical industry and in the manufacture of active pharmaceutical ingredients? The ECA aimed to evaluate this by conducting a survey.

In which areas is DoE already being used? How often is DoE used? These are just two of the questions asked in a survey conducted by the ECA. 51 participants took part in the survey.  Not every participant answered every single question, sometimes several answers were given by the same person, and rounding also contributes to the fact that the total sum of the answers does not always add up to 100%. Part I of the results is presented below.

Most participants came from companies with more than 500 employees (57%), 16% of participants work in companies with 101 - 500 employees, 12% come from companies with 51-100 employees and 14% from companies with 1-50 employees.

Company size of participants

The majority of the 51 participants came from the pharmaceutical industry and API manufacturers (47%), 18% were involved with biologics, 12% with chemical APIs, 10% manufacture medical devices and 2% came from the excipient sector.  Two participants came from an analytical laboratory that offers analytical services and one consultant and one participant came from a company that manufactures ATMPs.

Product range of the participants' companies

The question of the areas in which DoE is currently being used or where its use is planned was an interesting one. In each case, 27% stated chemical/biological development, closely followed by use in continuous process improvement (22%). Other areas of application are quality statistics and "other" with 10% each. Four percent named galenic development as an area of application for DoE. The response of those who selected "Other" is interesting. The following were mentioned

• all areas mentioned above
• Non-quality-related Six Sigma products
• Projects and audits
• Robustness testing
• Method validation

Areas in which DoE is already used or planned

The answers to the question "How often do you use DoEs?" were also interesting.

42% answered "sometimes", with 23% using DoE regularly. 17% rarely use DoE and only 6% use DoE daily. 13% do not use DoE at all.

Frequency of use of DoEs

Conclusion

The topic of DoE is definitely relevant in the pharmaceutical industry and for active ingredient manufacturers. The area of application is broad. To provide further assistance in this area, Concept Heidelberg is holding a DoE course for the ECA in Berlin on September 23/24, 2025: "Introduction to Statistical Design of Experiments in the Pharmaceutical Industry".

In Part II of this article, you can find the answers to the questions "In which areas will DoE be used in the future?", "What is the experience with the use of DoE?" and "What specific problems are there with DoE?"