Embedding Data Governance in Biologics Manufacturing for Greater Reliability and Efficiency

Sponsored by Enzene

Sundar Ramanan, PhD, MBA, Chief Quality Officer at Enzene, discusses the growing strategic importance of data governance in biologics manufacturing. He emphasizes that patient safety and drug efficacy rely on the integrity of data collected across development, manufacturing, quality control, and quality assurance, with data governance providing the framework for reliable decision-making and regulatory compliance.

To ensure data integrity and traceability, Dr Ramanan explains that companies should map the entire process from development to patient distribution, classifying each step as manual or digital and identifying potential errors. Most data integrity issues are unintentional, and implementing prevention, detection, and optimization mechanisms strengthens reliability and traceability.

Strong data governance not only supports compliance but also drives operational efficiency, reduces waste, and enhances overall quality. Once data is digitized, machine learning and AI can detect trends, improve process robustness, and support continuous improvement.

At Enzene, data and AI are being integrated across computerized and manual systems to optimize yield, decision-making, and predictive analysis. Looking ahead, Dr Ramanan notes that these tools will enhance efficiency, transparency, and collaboration between CDMOs and biotech innovators, building trust, accelerating clinical timelines, and ensuring consistent production of safe and effective biologics.