Abiozen’s Scale-Up Manufacturing capabilities bridge the critical gap between development and commercial supply, enabling pharmaceutical innovators to transition seamlessly from pilot-scale batches to high-volume production. Our facilities are built to handle complex, large-scale manufacturing with precision, ensuring product consistency, regulatory compliance, and rapid market readiness. With a focus on operational excellence, we support a full spectrum of therapeutic products, from small molecules to sterile injectables.

High-Volume API Synthesis
Our advanced infrastructure supports API synthesis at commercial scale, leveraging large-volume reactors and continuous manufacturing technologies. We can efficiently produce from kilogram quantities to metric tons, utilizing automation and real-time monitoring to ensure optimal process control. This results in consistent product quality and significantly enhanced throughput, even for highly potent or complex molecules.

Commercial Batch Production
We manufacture commercial batches in compliance with global GMP regulations, ensuring that every product released meets rigorous quality standards. In-line analytics and automated monitoring systems enable real-time quality checks throughout the production cycle. This minimizes process deviations and supports dependable product performance, batch after batch.

Advanced Manufacturing Technologies
Our facilities are equipped with cutting-edge process equipment, including high-shear granulators, fluid bed dryers, and aseptic filling lines for injectable dosage forms. ISO Class 5 cleanroom environments are maintained for sterile production, ensuring microbiological control and regulatory alignment for parenteral products. These technologies enable flexible and scalable production across multiple dosage forms.

Quality and Regulatory Excellence
Every stage of scale-up is governed by validated protocols, robust SOPs, and rigorous QA/QC oversight. Our global compliance framework ensures alignment with FDA, EMA, and other regulatory bodies, reducing delays in approval and accelerating launch timelines. This disciplined approach enables faster market access while maintaining unwavering product quality.

Partner-Centric Commercialization Support
We work as an extension of your technical and commercial teams, providing end-to-end support through technology transfer, process validation, and commercial launch preparation. With scalability, reliability, and global distribution in mind, Abiozen helps clients achieve successful market entry and long-term supply continuity.