Vaccine Stability Considerations to Enable Rapid Development and Deployment
March 24-25, 2021 - Virtual Event
Workshop Summary
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.
View the agenda and register now!
SAVE THE DATES
VIRTUAL Land O’ Lakes 2021
In partnership with UW-Pharmacy
22nd Annual Bioanalytical Conference
July 12-14, 2021
Stronger in the Future: What We Learned and How We Are Applying the Experiences of the COVID Years to Be Better Bioanalytical Scientists
The Land O’ Lakes 22nd Annual Bioanalytical Conference will present a unique look at what we had to learn very quickly in 2020 and 2021 in order to rise to the scientific and logistical challenges brought to us by the COVID-19 pandemic. The pharmaceutical industry rose to the challenge of producing vaccines and treatments at a pace we never thought possible. Bioanalytical laboratories worldwide played a significant role in developing these therapies to fight COVID-19 while also continuing to efficiently operate and bring new life saving therapies for the many other diseases of the world. In the three-day conference we will look at how many of the key advancements occurred, how they are being applied and what we see in the future of bioanalysis beyond the pandemic. The way we think and operate has forever been changed and we will take a look at these changes to reflect and learn and look forward.
Learning Objectives:
- Understand the major accomplishments of the last year in the context of the challenges that we faced as bioanalytical scientists.
- Learn of major advancements in bioanalytical science that enabled the success of pharmaceutical development in 2020.
- Evaluate the changes in logistics and infrastructure such as patient-centric clinical trials and remote working in our laboratories and how we will apply them to be better beyond the pandemic.
- Learn about the most recent breakthroughs in bioanalytical science in 2021.
- Take a look at the horizon of bioanalysis: where will be beyond the pandemic?
View the agenda, register, and submit a poster abstract
61st Annual Pharmaceutical Analysis Conference
August 9-11, 2021
Check website for updates