Optimizing access to high quality, standardized, and compliant leukopaks for the development and commercialization of allogeneic therapies

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

Cellular starting material is the most critical component in the allogeneic cell therapy manufacturing process. Ensuring material access while maintaining quality, consistency, and regulatory compliance are necessary throughout every stage of clinical development through commercialization.

As the development of allogeneic therapies continues to expand, having an industry-wide focus on standardization of processes will increase scalability and reduce timelines to the clinic.

In this webinar, we will review the key considerations for ensuring access to and consistency of leukopak products for allogeneic cell therapy starting material, such as donor pool size and repeat donations. This will include the key features and benefits of the NMDP BioTherapies’ standardized leukopak, showcasing the importance of standards to create quality and consistency as well as key modules developed to provide for flexibility and designed to allow developers to focus on the most key variables impacting manufacturing and clinical success. Additionally, variability in regulatory requirements around the world will be discussed as important considerations to ensure manufactured product is able to reach patients across the globe.

During this webinar you will learn about:

• Factors to ensure streamlined access to high quality and consistent starting material for allogeneic therapies
• Key regulatory requirements for donor cellular starting material, and how they vary between the US, EU, and other regions/countries
• Automatically taking into account multiple donor features like age, gender, geographical location, race, ethnicity, and more.
• Attributes of a standardized leukopak for allogeneic cell therapy manufacturing

Makensie Becker

Manager, Product Development at NMDP BioTherapies

Makensie Becker has over 10 years of experience in the biopharmaceutical industry. She currently works as the Manager of Product Development at NMDP BioTherapies, in which her and her team develop cutting-edge products that align with market demands, efficiently delivering solutions in a fast-paced and rapidly growing industry. Having previously served as both a Client Success Manager and Manager of Supply Chain Operations at NMDP BioTherapies, Makensie gained invaluable insights into the needs of cell therapy developers and navigated operational challenges in sourcing cellular starting material.

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SPEAKERS

Makensie Becker

Manager, Product Development at NMDP BioTherapies

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