Process development

Process development is the cornerstone of efficient and cost-effective biologics manufacturing. It encompasses the optimization of both upstream and downstream processes to maximize yield, ensure product quality and accelerate time to market. Key aspects of process development include:

• Upstream process development: Focusing on the initial stages of biologic production involve cell line selection and optimization of culture media, feed and bioreactor operation to maximize yield and quality. High-performing cell lines are selected with optimal expression, while chemically defined media formulations enhance growth and productivity. Bioreactor conditions, including pH, oxygen, and feeding strategies, are finely tuned for efficient large-scale production.
• Downstream process development: The purification and isolation of target biologics from the cell culture harvest, using techniques like chromatography, filtration and protein refolding (for bacterial origin denaturing format molecules) to ensure purity and quality
• Scalability: Developing robust processes that can be seamlessly scaled from R&D to clinical production, maintaining efficiency and product quality throughout.
• Process characterization and Process validation: Multi-factorial interaction studies to evaluate and fine-tune both upstream and downstream processes, identify bottlenecks and incorporate control strategy, ensure consistency and adhere to regulatory requirements.