Advances in Product Quality Control for Biologic Medicines
The 2024 BioMAN Workshop will be conducted as a hybrid event, featuring discussions on:
Drug manufacturers ensure the safety and efficacy of their products by rigorously controlling all aspects of the production process. Biomanufacturers, however, face significant challenges due to the complexity and biological variability of their products. Timely measurements of critical product quality attributes and process conditions are required to enable control strategies that achieve the required levels of process and product quality control. Additional understanding can allow manufacturers to predict product quality and respond in real time to trends or disturbances to ensure that the final product quality specification will be met. Advances in scientific understanding of the impact of raw materials and process conditions on the product and manufacturing process have also helped manufacturers achieve improved product quality as well.
This workshop will include case studies on product quality control for biologic medicines, including:
– Improvements in current analytical methods, including automation, and development of novel analytical methods and PAT, including hard and soft sensors, for improved product and process understanding
– Innovation in manufacturing platforms and control strategies for biomanufacturing processes
– Increases in understanding of the impact of raw materials on product quality and improvements in raw material quality control
– Technologies for automated visual inspection and rapid lot release
– Managing visible and sub-visible particulate impurities through product and process design
– Best practices in product quality control when working with contract manufacturer