Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment.

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.

Process and Method Variability Modeling to Achieve QbD Targets.

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.

Strategies of bringing drug product marketing applications to meet current regulatory standards.

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.

BIS repetita non placent -- a statistical analysis of the number of sample preparations and number of injections required for chromatographic analyses.

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.

Investigation of pharmaceutical high-performance liquid chromatography assay bias using experimental design.

This article presents a systematic approach to investigate, document, and eliminate pharmaceutical HPLC assay bias using experimental design. This is the first article to describe the application of experimental design in the area of assay bias. It is found that both formulation and analytical variables can contribute to pharmaceutical HPLC assay bias using model compounds and formulations.