Biopharmaceutical Manufacturing Conference: Embracing Technology And Innovation

By Louise Uí Fhatharta, manager/consultant with Pharmalex

The PDA Ireland Chapter hosted an event to discuss the role of innovation and technology in modern biopharmaceutical manufacturing. Industry leaders, experts, regulators, and technology companies gathered to share insights and explore emerging trends. Attendees from Ireland and overseas engaged in interactive discussions on new technologies and their potential impact on the industry.

A key focus of the event was the challenges and opportunities associated with implementing new technologies in aseptic and low bioburden processes. Regulatory inspectors highlighted the importance of knowledge management, as outlined in ICH Q8(R2), and emphasized the need for clear documentation and reproducible processes. Common deficiencies identified by the MHRA, such as mismatches between dossier and onsite processes and ineffective change control, underscore the importance of robust quality systems.

The event also explored strategies for operator engagement and empowerment, emphasizing the value of frontline workers' insights and contributions. Innovative training solutions and the use of digital twins were presented as tools to enhance quality, efficiency, and compliance. Additionally, advancements in data integrity, robotics, and real-time monitoring were discussed, highlighting their potential to improve product quality and reduce risk.

To learn more about the latest trends and best practices in biopharmaceutical manufacturing, read the full article.