Sanofi, a global pharmaceutical leader, set out to improve its tablet production process by identifying the optimal formulation and process conditions. With strict regulatory requirements from the FDA and EMA and high costs associated with experimentation, the team needed a more efficient way to generate reliable results. By adopting Effex, now Minitab DOE by Effex, Sanofi streamlined experimentation, reduced costs, and accelerated development timelines.
Why Sanofi Chose Effex
Sanofi needed a structured approach to experimentation that could handle complex, high-dimensional problems without requiring excessive time or materials.
Traditional trial-and-error methods were too slow and resource-intensive, especially when evaluating multiple interacting factors. The team required a solution that could:
- Efficiently explore many variables at once
- Reduce the number of experimental runs
- Deliver statistically reliable insights for regulatory compliance
With Minitab DOE by Effex, Sanofi gained access to advanced experimental design methods that made it possible to design smarter experiments from the start and extract more insight from each run.
The Challenge
To optimize tablet production, Sanofi needed to determine the ideal combination of formulation ingredients and process parameters while ensuring final products met strict regulatory standards.
This required extensive experimentation across many variables. However:
- Each experimental run was costly
- Raw materials were expensive and limited
- Traditional methods required too many iterations
- Timelines for development were too long
Sanofi needed a way to reduce experimentation time and cost without compromising data quality or outcomes.
The Solution
Sanofi implemented Minitab DOE by Effex to design and execute more efficient experiments.
Using advanced DOE methods, the team was able to:
- Evaluate multiple factors simultaneously
- Reduce the number of required experimental runs
- Identify optimal conditions faster
- Improve the efficiency of the entire development process
The approach followed a structured workflow:
- Defining the experiment: Sanofi and the team carefully designed experiments to maximize insight from each run, accounting for the high cost of data collection.
- Executing the experiment: Experiments were conducted across different tablet formulations and process conditions.
- Data collection and analysis: Data was analyzed to identify the most effective parameter combinations and understand interactions between variables.
- Optimization: Insights were applied to refine production processes and ensure consistent product quality.
The Results
Sanofi successfully optimized its tablet production process while significantly reducing the cost and time required for experimentation. Their results included:
- Reduced testing timeline from six months to approximately four months
- Saved 10 kg of high-cost raw materials
- Decreased the number of experimental runs required
- Improved ability to evaluate multiple variables simultaneously
- Achieved high-quality, reliable data for decision-making
- Met regulatory requirements with greater confidence
By improving how experiments were designed and executed, Sanofi accelerated development while maintaining strict quality standards.
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Sanofi
The Organization
- Global pharmaceutical company
- Headquartered in Paris, France
- Develops medicines and vaccines across multiple therapeutic areas
The Challenge
- High cost of experimental runs
- Complex, multi-factor formulation problem
- Long development timelines
- Strict FDA and EMA requirements
Products Used
Minitab DOE by Effex™
The Results
- Reduced testing timeline from approximately six months to four months (33%)
- Saved significant raw material costs
- Fewer experimental runs required
- Faster identification of optimal conditions