Process Development for Biologics

Developing biologic therapeutics requires optimized processes to address their complexities and variabilities. Specialized strategies are essential to ensure consistent product quality, scalability, and regulatory compliance while reducing development risks.

Upstream process development focuses on optimizing cell culture conditions, including clone selection, bioreactor parameter screening, and scale-down model development to enhance productivity and product quality. Robust purification strategies streamline downstream processes, including chromatography optimization, filtration, and viral clearance, ensuring high manufacturing yields and regulatory compliance.

Comprehensive analytical support underpins every stage, identifying critical process parameters (CPPs) and maintaining critical quality attributes (CQAs) to deliver a scalable and reproducible process.

Access our info sheet to learn more about Abzena’s comprehensive process development strategies that optimize efficiency, reduce risk, and enable successful scale-up.