Your particle engineering partner for drug substance manufacturing
Particle engineering is the science of designing and controlling the size, shape, structure, and surface characteristics of particles to meet specific performance and processing requirements. In pharmaceutical manufacturing, it plays a critical role in ensuring that drug substances meet quality, bioavailability, and formulation targets.
At Evonik, we apply particle engineering across the entire drug substance lifecycle—from crystallization to drying, milling, and beyond. As a trusted partner in contract manufacturing and manufacturing services, we help pharmaceutical companies develop robust, scalable processes that support everything from early development to clinical trial supply and commercial production.
Why Is Particle Engineering Important for API Manufacturing?
Particle properties directly influence:
- Solubility and bioavailability
- Flowability and compressibility for tableting
- Filtration and drying efficiency
- Stability and shelf life
- Downstream processability
By engineering particles with the right characteristics, we help ensure that your small molecule APIs perform as intended—both in the lab and in the final dosage form.
Our Holistic Approach to Particle Engineering
Evonik’s particle engineering strategy is built around four key stages:
We begin with solid-state investigations, including:
- Solid form screening (polymorphs, solvates, co-crystals)
- Solvent selection and phase diagram development
- Thermodynamic and kinetic profiling
- OMICS-based insights for form selection
We define:
- Desired particle size and distribution
- Shape, roughness, and mechanical properties
- Yield, impurity profile, and polymorphic form
- Bulk properties like density, flowability, and compressibility
We select the right crystallization method (e.g., cooling, antisolvent, concentration) and equipment to:
- Achieve the desired solid form
- Control particle size and morphology
- Improve yield and purity
- Ensure downstream compatibility
We ensure that lab-scale processes translate to production by evaluating:
- Equipment geometry and mixing dynamics
- Temperature control and addition rates
- Holding times and agitation profiles
Crystallization: The Core of Particle Engineering
Crystallization is often the most critical step in defining particle properties. At Evonik, we use crystallization not only to isolate the desired solid form but also to control:
- Particle size distribution (PSD)
- Morphology and surface texture
- Phase transitions and polymorphic stability
We offer both batch and continuous crystallization technologies, including:
- MSMPR (Mixed Suspension Mixed Product Removal)
- Evaporation crystallization
- Melt crystallization for low-melting-point substances
Advanced Capabilities in Particle Engineering
- Small-scale (2–30 mL) and medium-scale (100–200 mL) systems
- Solubility and metastable zone width (MSZW) determination
- Solvent and solid form screening
- Filtration and centrifugation trials
- Filter cloth selection and filter cake compressibility testing
- Generation of amorphous particles
- Particle size control and encapsulation
- Suitable for heat-sensitive APIs
- Available at lab, pilot, and production scale
- Selection based on particle size, energy input, and containment needs
- Cryogenic milling for temperature-sensitive APIs
- Full range of mills at lab and production scale
Analytical Tools for Particle Engineering
Our particle engineering lab is equipped with advanced in-situ and offline tools, including:
- In-situ particle tracking and imaging
- FTIR and Raman spectroscopy
- Hot-stage microscopy
- DSC (Differential Scanning Calorimetry) for melting point analysis
We also collaborate closely with Evonik’s central analytical department, giving us access to a broad suite of techniques and expert interpretation for every stage of development.
How Evonik Supports Process Design and Optimization
Evonik’s integrated approach ensures that particle engineering is not an afterthought—it’s embedded in every step of process design. We help you:
- Select the optimal solid form
- Design robust crystallization and isolation processes
- Control critical quality attributes (CQAs)
- Ensure scalability and regulatory compliance
- Improve supply chain efficiency through better processability
Whether you're developing a new small molecule API or optimizing an existing process, our team of chemists and engineers is ready to support your success.
Partner with Evonik for Particle Engineering Excellence
As a global leader in contract manufacturing and pharmaceutical manufacturing services, Evonik offers:
- Deep expertise in particle engineering and crystallization
- End-to-end support from development to commercial scale
- Proven success in clinical trial and commercial API production
- A collaborative, science-driven approach to solving complex challenges
Get in touch to learn how our particle engineering capabilities can help you bring your next pharmaceutical product to market—faster, smarter, and more sustainably.
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"Exploring options for the development and manufacture of your cGMP small molecule drug substance or associated intermediates? Reach out and we'll help you make well informed choices as Evonik aims at getting clients practical solutions faster and easier."
Eric Neuffer
Head of Drug Substance Sales
