Vaccines are at the forefront of public health worldwide, especially during the 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 their formulation, and carrying through their processing, 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 present many challenges. Fortunately, analytical tools and stability strategies are advancing in parallel.
Vaccines are complex products. Any changes in process, formulation, shipping, and/or storage can cause physical and/or chemical changes in a product. Vaccine stability, which is reflected by monitoring its critical quality attributes, can be affected by cell culture media composition (nutrients and metals) and cell culture process conditions (pH, temperature, dissolved oxygen, carbon dioxide). Cell density can also cause cell stress leading to off-target product quality attributes. Moreover, other process operation units can also affect stability, such as downstream process (different load, pH, and buffers), drug product formulation and process, container and closure, and shipping and storage.
This workshop will discuss pinch points along with the latest stability strategies and tools to optimize product shelf-life, and meet global regulations and supply needs to help scientists working in stability ensure the best shelf-life for their products. Attendees can expect a unique perspective that comprehensively links the entire bioprocess operation units end-to-end with the goal of understanding the impact of process on drug stability. Attendees will improve their understanding of the underlying causes for drug stability of biopharmaceutical products in order to potentially reduce unnecessary testing and improve efficiency, and thus reduce cost and accelerate access to patients.
Participants attending this workshop will learn:
- The impact of the following on stability of Vaccines:
- Formulation Impurities
- 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
- Modelling / 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
Jianmei D. Kochling, Ph.D., Sanofi (Chair)
Mark S. Alasandro, Ph.D., MZA Consulting
Kim Huynh-Ba, M.S., PMP, FAAPS, Pharmalytik LLC
Yan Wu, Ph.D., Merck & Co., Inc.
Yajie Zhang, Ph.D., Regeneron
Lori McCaig, Ph.D., Seagen, Inc.
Nanda Subbarao, Ph.D., Biologics Consulting Group