Crystallization Process Development

Scalable, QbD-Driven Crystallization Process Engineering

The aim of crystallization process development is to find a stable, reproducible process that consistently produces the optimal solid form with all desired properties — including particle size, shape, bulk density, purity, yield, and residual solvent content. At Crystal Pharmatech, we build crystallization processes from a foundation of deep physicochemical understanding, ensuring every parameter is controlled and every scale-up is predictable.

Designing to Critical Quality Attributes

Our primary objective is to design a stable, reproducible crystallization process that yields the optimal solid form while hitting all desired critical quality attributes (CQAs):

Chemical Purity

Organic impurities
Chiral upgrade
Residual solvents
Residual metal contents

Physical Form & Purity

Desired solid/crystal form
Undesired solid/crystal forms
Form inter-conversions

Physical Properties

Particle Size Distribution
Bulk Density
Particle Flow Property
Solubility
Hygroscopicity

Featured Process Development Capabilities

We provide end-to-end process development to ensure your crystallization process is robust and ready for scale-up:

Method Selection Strategic evaluation and selection between cooling crystallization, anti-solvent crystallization, and combined approaches based on API solubility behavior.
Solvent Optimization Precise solvent and anti-solvent selection based on solubility curves, metastable zone width measurements, and thermodynamic phase data.
Form Control Systematic protocols to ensure the desired polymorph or salt form is consistently produced and thermodynamically stable under process conditions.
Parameter Optimization Masterful control over supersaturation, seeding, temperature ramp rates, filtration, and drying conditions.
Impurity Rejection and Purification Targeted strategies to minimize impurity incorporation during crystallization, achieving API purity specifications with high yield.
Output Achievement Strict control over impurities, morphology, residual solvents, and PSD while maximizing productivity.

Quality by Design and Scale-Up Readiness

All process development work is conducted using QbD principles, ensuring that parameter ranges and control strategies are scientifically justified and regulatory submission-ready:

Design of Experiments (DoE) to efficiently map the process design space

Identification and control of critical process parameters (CPPs)

Risk assessments for scale-up from laboratory to pilot to commercial GMP scale

Compatibility studies for downstream operations: filtration, drying, milling, and material handling

Achieve Your Success with Our Expertise

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Our capabilities span three specialized platforms:

Small Molecule
Crystal Bio Solutions
Crystal NAX

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