March 24-25, 2021 - Virtual Event
Summary
Vaccines are at the forefront of public health worldwide, and during this COVID-19 pandemic. It is critical that we build systems for their rapid development and deployment. To meet this need, stability must be designed into the development of new vaccines, starting with the formulation, and carried through to the process, packaging, storage, and distribution. Each step must be optimized and controlled. Scientists working in stability must collaborate with formulators to build efficient processes, as well as ensure proper upstream and downstream testing, final drug product characterization, release and stability testing, and shipping studies. The inherent stability (or instability) of biologics, the ever-expanding range of different vaccine modalities, and the need to maintain vaccine quality through a complex global supply chain presents many challenges. Fortunately, the analytical tools and stability strategies are advancing in parallel.
Participants attending this workshop will learn:
- The impact of the following on stability of vaccines:
- Formulation impurities
- Lyophilization
- Container closure, shipping, and storage at vaccination centers
- Stability Assessment: In-silico and experimental approaches
- Stability strategies and analytical techniques for early assessment of formulation stability
- Modeling / predictive stability
- Assignment of expiry dating for vaccines
- Special studies to support transport, storage, and use in the “last mile”
- Perspective: How the needs of the supply chain and patient should drive the design for stability studies
- The challenge of distribution, patient access and supply limitation