Vaccine Stability

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.

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
- 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

Programming Committee

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

Registration

	All Sessions	Single Session
Member	$450	$150
NonMember	$645	$200
Student/ Post-Doc Member	$105	$50

All registrants will have access to the session slides and recordings post-event.

Cancellation & Refund Policy

Cancellations must be submitted to AAPS in writing to [email protected] and will be honored as follows:

AAPS will issue a refund to any attendee who cancels at least two (2) business days in advance of the event:

If you cancel your registration on/before March 22, 2021 you will be refunded your registration fees minus an administrative fee of $50 for members/non-members or $25 for students.
In the case of a multi-day event, cancellation must be received no later than 2 business days before the first scheduled webinar date/start time.
Cancellations received less than 2 business days before the scheduled event date/start time will not be refunded.
In the rare event that AAPS must to cancel due to circumstances beyond our control, we will make every effort to notify attendees as quickly as possible. Attendees will be given the opportunity to either transfer to another webinar or obtain a full refund.

No refunds will be given for “no shows” or for attendee technology problems. It is the responsibility of the attendee to test their computer setup before the start of the webinar. If a technical failure at your home or workplace prevents access to the live event, you are not eligible for a refund. If the technical problem is due to our error, we will issue a refund.

Vaccine Stability Considerations to Enable Rapid Development and Deployment

Summary

Registration

Thank you to our workshop sponsors!