At Abiozen, our crystallization and purification processes are engineered to deliver exceptional API purity and long-term stability—two critical parameters that influence therapeutic performance and regulatory acceptance. We apply sophisticated, multi-layered refinement methods that elevate our super generic APIs to meet and exceed international quality standards.

Multi-Stage Crystallization

Our multi-stage crystallization processes are designed to control particle size, distribution, and crystal morphology with high precision. By leveraging techniques inspired by Curia Global, we optimize the physical characteristics of APIs to enhance formulation compatibility, dissolution rates, and overall product performance. This level of crystallographic control is integral to ensuring uniformity in dosage forms.

Solvent-Based Purification

Through carefully selected solvent systems, we eliminate process impurities and residual solvents to levels well below ICH threshold limits. Our purification workflows, influenced by Thermo Fisher Patheon’s advanced purification models, are validated to ensure batch reproducibility, regulatory compliance, and safety. These methods are particularly effective in preserving the integrity of sensitive and high-potency compounds.

In-Line Monitoring and Real-Time Adjustments

Our facilities are equipped with in-line analytical instruments that provide continuous data on crystallization and purification parameters. These tools enable real-time adjustments during manufacturing, reducing rework, improving yield, and ensuring consistency. This approach, modeled after Thermo Fisher CRDMO’s integrated monitoring framework, supports a lean, quality-focused production environment.

Regulatory-Ready Outputs

By integrating these advanced methodologies into our core manufacturing strategy, Abiozen consistently delivers APIs that are stable, pure, and compliant with regulatory standards across global markets, including the USFDA, EMA, TGA, and PMDA. This ensures that every product shipped is not only market-ready but capable of supporting expedited regulatory approvals worldwide.