Unlock Efficiency: Leverage The Right Digital Tool To Build Process Knowledge And Streamline Drug Development

By Unjulie Bhanot, Product Marketing Manager, Process Development & Manufacturing, IDBS

Over the last 50 years, the BioPharma industry has transitioned from paper-based to digital laboratory informatics, focusing on data collection rather than process knowledge. While tools like ELNs, LIMS, and LES manage experimental records, samples, and workflows, they lack integration for optimizing critical process parameters.

Historically, drug development saw breakthroughs with small-molecule drugs, monoclonal antibodies, and biologics. With increasing regulatory oversight, digital tools evolved to ensure compliance and streamline operations. However, modern challenges demand a shift toward capturing and managing process data to improve drug quality and accelerate tech transfer.

Digital maturity is essential for competitive advantage, enabling seamless tracking of materials, equipment suitability, and analytical methods. Yet, current fragmented systems create data silos, limiting collaboration and process optimization. Without real-time insights into how parameters impact yield and product structure, inefficiencies and regulatory risks persist.

Quality by Design (QbD) principles emphasize integrating process knowledge across development stages. To enhance quality and efficiency, BioPharma companies must adopt process-focused digital solutions, leveraging AI and machine learning to transform data into actionable intelligence.