Abiozen’s biologics manufacturing capabilities are designed to meet the growing global demand for advanced, large-molecule therapeutics. We specialize in the production of monoclonal antibodies, therapeutic proteins, and biosimilars using high-efficiency bioreactors and advanced cell culture technologies. Our platform ensures the preservation of biological activity, product integrity, and regulatory compliance throughout the production lifecycle.

Advanced Upstream and Downstream Processing

Our upstream capabilities include perfusion and fed-batch systems that optimize cell density and maximize protein expression, delivering titers up to 10 g/L for monoclonal antibodies. In downstream processing, we implement multi-stage purification workflows—affinity chromatography, ion exchange, and size exclusion—to achieve purity levels above 99%, with ultrafiltration ensuring final refinement. Our optimized media and feeding strategies maintain cell viability above 95%, improving both efficiency and cost-effectiveness.

Technological Innovation and Contamination Control

Inspired by Curia Global’s scalable manufacturing model, we deploy single-use bioreactors up to 2,000 L to mitigate cross-contamination and enhance flexibility. Our continuous bioprocessing systems shorten production timelines and increase throughput. All biologics are handled in Grade A cleanrooms, supported by HEPA-filtered air and continuous environmental monitoring to uphold the highest sterility standards.

Scalability and Global Regulatory Alignment

Abiozen accommodates a full range of batch sizes—from early-phase clinical runs (10–50 L) to full commercial-scale production (up to 2,000 L). We provide end-to-end regulatory support, including Drug Master Files (DMFs) and Biologics License Application (BLA) submissions, ensuring full compliance with USFDA, EMA, and global regulatory frameworks.