Annual Meeting 2021

Virtual Meeting - February 28th to March 5th

Non-invasive 3D X-Ray microscopy imaging technique for quantitative characterization of lyophilized drug product

With FDA

A stable and robust freeze-drying process is highly desirable in pharmaceutical lyophilization to ensure homogenous and intact cake appearance. Process parameters and physio-chemical properties, such as freeze-dried cake moisture content, reconstitution time, integrity, homogeneity, uniformity and potency, are often employed to confirm drug product quality as well as its stability under storage. In this study, we explored the application of a high-resolution, non-invasive imaging with X-Ray Microscopy (XRM) to collect three-dimensional (3D) volume data from lyophilized samples non-destructively, followed by quantification with an artificial intelligence (AI)-based image processing method as a new powerful tool for quantitative and qualitative cake structure characterization. Go here for more information.

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Root cause analysis of an inverse relationship between the ice nucleation temperature of a controlled ice nucleation process, process performance and product attributes

By Dr. Maxwell Korang-Yeboah from FDA with DigiM

The ongoing pandemic has highlighted the need to increase the agility, efficiency, and robustness of pharmaceutical processes. Controlled ice nucleation (CIN) technology is an innovative technology for lyophilization because it offers the advantages of an improved process efficiency, a shortened process time and cost, improved batch homogeneity and product quality. Despite the advantages, CIN is yet to be employed at manufacturing scale for lyophilization of biologic drug products. This presentation will highlight some of the potential challenges and potential mitigating strategies. More importantly, we will show how a combination of advance techniques such as inline vapor flux monitoring, automotive water activity analyzer, and advance imaging and artificial intelligence can be used to improve our understanding of the relationship between CIN process parameters, process performance and the ensuing product quality attributes.

Assessing the risk of changes in container closure system of a freeze-dried product on primary drying efficiency and product quality

By Dr. Maxwell Korang-Yeboah from FDA with DigiM

Container closure system (CCS) of pharmaceutical products play an essential role in maintaining the product quality throughout the shelf life and during its use. Freeze drying, involving heat and mass transfer phenomena, is highly affected by  the characteristics of CCS. Therefore, a change in CCS without making corresponding adjustments in the freeze-drying process may alter the process performance and  product quality. A systematic evaluation was conducted to determine the CCS variables, formulation characteristics, and freeze-drying process parameters with the highest risk of process failure upon changes in CCS without concomitant changes in the freeze-drying process. The CCS variables that were evaluated were the concentration of biologic drug substance in the formulation, total solid content, and fill height. In addition, we studied the impact of the freezing (conventional freezing, annealing and controlled ice nucleation) and the primary drying parameters (shelf temperature and chamber pressure) on the extent of  potential risk to process and product failure. Our results revealed that changing the CCS of freeze-dried products without concomitant adjustments in the freeze-drying process parameters may lead to a loss in process efficiency and product quality.