Patient safety should always be the number one priority in the pharmaceutical safety testing process. Even when developing alternatives to traditional laboratory animal testing, this priority must remain the same. With this in mind, the development of in-vitro methods is highly regulated to ensure that patients are not compromised by the use of inferior methods.
As an example of this, in this webinar we will review the development of an alternative method for the highly precise Mouse Potency Bioassay. This will include the requirements for the assay set out by regulatory bodies, difficulties presented in the development of an alternative and the approaches currently being undertaken.
We will then discuss Pyrogen testing, where the in-vitro alternatives have been widely adopted over the in-vivo method. Our speakers will present a case study where the limitations of each method (LAL, MAT and Rabbit Pyrogen) are discussed when considering the best choice for a difficult preparation.
Understanding the process and complications involved in the development and validation of in-vitro alternatives is vital to choosing the best method for your product and we invite you to join us as we consider the in-vitro vs in-vivo debate and explore further why roadblocks may occur in the method development process.
Shellie Davies BSc
Section Head - In-Vitro Toxicology
Shellie joined Wickham Laboratories Ltd in 2009 as an Animal Technician in the Toxicology Department. She became a Senior Technician in 2012 and began work in establishing the new In-Vitro Toxicology department.
In 2013, Shellie was employed as the associate of a Knowledge Transfer Partnership between Wickham Laboratories Ltd and the University of Southampton to research in-vitro capabilities for the testing of toxic drug products.
Her degree was received from Bournemouth University in 2009 in the area of Animal Biology, Behaviour and Welfare and she is currently near completion of a Masters in Neuroscience.
Sophie Bell BSc
Senior Technician - In-Vitro Toxicology
Sophie Bell joined Wickham Laboratories in 2016 as a Technician in the In-Vitro Toxicology department. She was promoted to Senior Technician the same year and currently specialises in in-vitro Pyrogen testing and Cell Culture methods.
She received her Bachelor’s degree in Biomedical Sciences from the University of Sheffield in 2015.
- Understand the requirements for an in-vitro alternative
- Learn about the process and complications of alternative method validation
- Discover the limitations with compendial alternative methods currently in use
- Discuss the feasibility of replacing all in-vivo methods with in-vitro alternatives
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