ABSTRACT
The Stability Community of the American Association of Pharmaceutical Scientists (AAPS) held a virtual workshop on "Vaccine Stability Considerations to Enable Rapid Development and Deployment", on March 24-25, 2021. The workshop included distinguished speakers and panelists from across the industry, academia, regulatory agencies, as well as health care leaders. This paper presents a review of the topics covered. Specifically the challenges in accelerating vaccine development and analytical characterization techniques to establish shelf-life were covered. Additionally, vaccine stability modeling using prior knowledge stability models and advanced kinetic analysis played a key in the EUA approaches discussed during the workshop. Finally, the role of stability studies in addressing the challenges of vaccine distribution and deployment during the pandemic were a focus of presentations and panel discussions. Although the workshop did not have any presentation topics directly dedicated to the mRNA vaccines, the techniques discussed are generally applicable. The mRNA vaccine developers were represented in the panel discussions, where experts involved in the EUA approval/deployment stages for this vaccine type could discuss the challenges as applied to their vaccines.
ABSTRACT
A statistical modeling tool is presented that enables real-time viewing of how changes in method, process, and stability variability/bias impact product acceptance rate. The tool can be used to set and justify specifications. As needed, additional sources of variability/bias can be added to further optimize the tool's prediction power. The tool can be used to assess each manufacturing run to ensure the process is in control. Aberrant results can then be investigated to see what source of variability/bias may have changed. To enable continuous improvement, the impact of new processes, methods, or technologies can also be addressed and such changes justified.
Subject(s)
Chemistry, Pharmaceutical/methods , Quality Control , Technology, Pharmaceutical/methodsABSTRACT
In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspections while companies continue to make changes through the product life cycle for continuous improvement or market demands. This discussion presents different strategies to bringing drug product marketing applications to meet current and emerging standards. It also discusses stability and method designs to meet process validation and global development efforts.
Subject(s)
Marketing , Pharmaceutical Preparations , Guidelines as TopicABSTRACT
This article attempts to answer the question of how many replicate sample preparations and replicate chromatographic injections must be done to provide accurate results in chromatographic analyses of pharmaceuticals. Using a random selection of chromatographic runs obtained with 1-3 replicate preparations and duplicate injections, the variance associated with preparation-to-preparation and injection-to-injection variability were estimated by a mixed-model statistical analysis. The analysis also predicted the probability that two injections of the same sample preparation are not in agreement with each other. Results indicated that, with modern chromatographic equipment, duplicate injections do not improve the precision. The number of replicate preparations needed to provide accurate results for various types of analysis depends on the type of sample and the desired tightness of the specification limits.
