Preserving Stability, Ensuring Sterility, Enabling Global Access

Lyophilization, also known as freeze-drying, is central to Abiozen’s sterile manufacturing strategy. This advanced technique enhances the stability and shelf life of injectable APIs and biologics while preserving structural integrity and therapeutic efficacy. Our expertise in this domain—bolstered by insights from industry leaders like Curia Global—positions us as a reliable partner for pharmaceutical companies aiming for global distribution with uncompromised quality.

Core Technology Features
Our lyophilization suites are equipped with automated systems that precisely control freezing, primary drying, and secondary drying phases. Controlled nucleation techniques facilitate uniform ice crystal formation, minimizing variability and protecting product structure. Vacuum levels as low as 0.01 mbar and condenser temperatures below -80°C ensure optimal sublimation, preventing product collapse and maintaining sterility. These features enable consistent results across peptides, biologics, and complex formulations.

Automation and Compliance
Real-time monitoring of shelf temperature, chamber pressure, and condenser performance is executed through systems compliant with 21 CFR Part 11, ensuring traceable, audit-ready data integrity. This high level of automation supports both operational excellence and rigorous quality assurance processes. Continuous data logging improves batch-to-batch consistency and enables proactive quality control throughout the freeze-drying cycle.

Flexible Production Capacity
Abiozen offers scalable lyophilization solutions to accommodate varying production demands. Our pilot-scale lyophilizers are ideal for clinical trials and formulation development, offering precise process control for small batches. For commercial-scale operations, we support up to 50,000 vials per cycle, ensuring seamless scalability from R&D to global launch, with production agility that aligns with evolving market needs.

Analytical Testing and Quality Control
Our analytical framework ensures that all lyophilized products meet the most stringent global quality standards. We conduct Karl Fischer titration for moisture content (targeting <1%), gas chromatography for residual solvents per ICH Q3C, and sterility validation per USP <71> and EP 2.6.1. We also assess reconstitution time and cake appearance to ensure clinical usability and patient safety.

Formulation and Process Optimization
Our formulation scientists leverage cryoprotectants and lyoprotectants such as sucrose and trehalose to prevent aggregation and denaturation of sensitive molecules. Tools like freeze-drying microscopy (FDM) are used to develop and optimize freeze-drying cycles, fine-tuning parameters like freezing rate and drying time. These optimizations ensure robust, reproducible results across all product types, including monoclonal antibodies and peptide APIs.

Regulatory and Global Readiness
Abiozen’s lyophilized products are fully aligned with international regulatory standards, including USFDA, EMA, and PMDA guidelines. Each product is developed with global distribution in mind, with comprehensive documentation, validation reports, and compliance testing to facilitate seamless market entry and regulatory approval across North America, Europe, and Asia-Pacific.