Design of Experiments (DoE)
Structured experiments that turn data into design space, control strategy and defendable decisions.
Design of Experiments (DoE) is the backbone of modern process understanding and PAT model development. Without well-designed, structured experiments, you risk building models on weak foundations and missing critical interactions between parameters and quality attributes.
Amalia Technologies designs, plans and analyses DoEs that feed straight into QbD, PAT and control strategy decisions, so experimental work translates into defendable design spaces, robust models and clearer validation narratives rather than piles of disconnected data.
DoE is underused, leading to limited process understanding
Continued reliance on one-factor-at-a-time experiments
PAT models built on opportunistic rather than designed data
Late discovery of interactions and non-linear effects
Weak linkage between CMAs, CPPs and CQAs
Fragmented documentation and limited regulatory clarity
Why DoE matters
Design risk-based, statistically sound experimental programmes
Identify and rank critical factors efficiently
Capture interactions and define robustness margins early
Generate high-quality data for PAT, chemometrics and modelling
Build clear, defensible design spaces and control strategies
What we do under Design of Experiments (DoE)
We offer end-to-end support for DoE, from initial scoping to analysis, interpretation and knowledge capture, following a clear structured flow.
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Define objectives, responses, factors and constraints
Clarify how results will be used (screening, optimisation, robustness, model building, regulatory justification)
Decide whether you need screening, optimisation or robustness designs—or a sequence of these
Consider practical limits such as material availability, safety, run time and plant access
This ensures the DoE is anchored in business, process and regulatory needs, not just statistical curiosity.
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Work with your scientists and engineers to choose appropriate design families
Check proposed designs against equipment, safety and compliance constraints, including any GxP expectations
Make sure designs are compatible with your PAT tools and data-collection capabilities (Raman, NIR, FTIR, UPLC or other sensors) so the right measurements are built in from the start
We keep the designs as simple and efficient as possible while still answering the questions you care about.
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Prepare clear run sheets and data-capture plans for operators and scientists
Define checks for data completeness, plausibility and outliers
Provide support during execution to troubleshoot design-related questions and keep the DoE on track
Day-to-day project management and co-ordination are part of the service; we take ownership of the work, not just the analysis afterwards.
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Use tools such as multivariate analysis and design-space visualisation where relevant
Work with your scientists and engineers to interpret main effects and interactions in process and business terms
Support the development of predictive chemometric models for use in PAT, soft sensors and control strategies, with clear limits of applicability
Link results to QbD concepts such as design space, CPPs and control strategy using language that aligns with ICH expectations
We typically review results in working sessions with your teams so decisions and next steps are clear and owned by the people who run the process, not buried in reports.
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Develop concise reports and slide decks that support QbD dossiers, validation documentation and internal governance
Create clear graphics and narratives that make the story easy to follow for QA, regulatory and senior management
Make explicit links between DoE results, design space, PAT models and control strategy, so your lifecycle story is coherent and easy to explain
We also hand over relevant source files (for example design and analysis files) and provide guidance on how to reuse the approach for future studies.
Deliverables
A typical DoE engagement with Amalia includes:
We help your team define objectives, constraints, and decision criteria.
We work with your team to select designs and prepare run sheets and data plans.
We can provide templates and guidance for data quality and traceability during studies.
Explain effects, interactions, and propose design space or operating ranges.
Structured outputs that feed directly into QbD sections and control strategies,
We can provide design and analysis files, templates, and guidance for reuse.
DoE becomes a strategic asset for PAT and QbD, not a one-off statistical exercise.
Customer Stories & Insights
Outcomes you can expect by working with Amalia
From a DoE engagement with Amalia you can expect support that leads to:
Models built on structured experimentation rather than opportunistic data.
Including which factors matter, where interactions lie and where robustness margins are thin.
Material that can flow directly into QbD packages and regulatory dossiers.
Efficient designs that maximise learning for a given amount of material, time and plant access.
Templates and ways of thinking that your teams can reuse across products, sites and PAT initiatives.
When to consider Design of Experiments (DoE)
Are planning PAT model development and want structured experimental data rather than opportunistic sampling
Need to define or justify a design space as part of QbD work
Face unexplained variability and need a systematic way to explore factors and interactions
Are preparing for continuous- or semi-continuous manufacturing projects that require understanding of dynamic behaviour and control windows
Want to embed DoE good practice across teams and sites rather than relying on a few “statistics specialists”
We can support a single critical DoE or help you establish a scalable DoE approach across portfolios, sites and PAT initiatives.
Why Amalia
We help organisations turn complex change into solutions that people actually use. We combine structure, respect and creativity so your teams deliver better outcomes with less friction. Here is what that looks like in real engagements.
We remove what isn’t needed while keeping essential controls and compliance. The result is clear, practical systems that are easy to adopt and maintain.
A single, senior, cross-functional team replaces multiple vendors. Fewer hand-offs, faster delivery, and one accountable partner throughout.
We align leadership, QA, IT and operations around shared decisions. Clear reasoning, documented outcomes, and no misalignment.
Solutions are built around real processes and real risk. Practical delivery that avoids shelfware and drives measurable outcomes.
We bring global experience and adapt it to your specific context and operating reality. Proven frameworks, applied flexibly where they matter most.
Senior leaders stay involved from start to finish on every engagement. Each programme is treated as a long-term partnership, not a one-off project.
Want to simplify complex work without losing control?
Work with a team that can join up governance, assurance, platforms and technical depth from start to finish.