At Abiozen, sterile active pharmaceutical ingredient (API) production forms the backbone of our injectable drug development platform. We specialize in the manufacture of high-purity sterile APIs optimized for both clinical and commercial use. Leveraging best-in-class practices from leading CDMO organizations such as Curia Global, Thermo Fisher Patheon, and Thermo Fisher CRDMO, our operations are engineered to exceed international expectations across safety, efficacy, and scalability.

World-Class Infrastructure and Automation

Our ISO Class 5 (Grade A) cleanrooms ensure an ultra-low particulate environment, continuously monitored by advanced particle counters and microbial air samplers. These stringent conditions virtually eliminate contamination risks. Robotic automated filling lines further minimize human intervention, delivering precise, consistent vial dosing from 2 mL to 100 mL. Multi-layered in-line filtration and sterilization systems, including 0.22-micron filters and sterilization via autoclaving or gamma irradiation, guarantee final product sterility.

High-Purity Production with Real-Time Quality Assurance

Abiozen delivers API purity exceeding 99.5%, validated through high-performance liquid chromatography (HPLC) and mass spectrometry (MS). In-line sensors and automated data logging support real-time quality checks at every stage of production, ensuring each batch is manufactured with exceptional precision and consistency.

Scalable and Adaptive Manufacturing

Our production model supports seamless scalability—from 1 kg R&D-scale batches to 1,000 kg commercial runs—while maintaining rigorous quality standards. Rapid reconfiguration capabilities enable us to meet the evolving needs of pharmaceutical innovators with efficiency and speed.

Regulatory Excellence and Inspection Readiness

We maintain full compliance with USFDA, EMA, cGMP, and ICH guidelines. Our regulatory affairs team ensures all documentation is complete and inspection-ready, including electronic batch records (eBRs) and comprehensive audit trails. This robust compliance framework enables Abiozen to serve as a trusted sterile API manufacturing partner across regulated global markets.