Navigating CAR-T manufacturing: from research to GMP readiness

Tuesday 09:00 PDT / 12:00 EDT / 16:00 GMT / 17:00 CET

Sponsor

Navigating CAR-T manufacturing: from research to GMP readiness

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

Cell and gene therapies (CGTs) are among the most complex drug products that the biotech and pharmaceutical industry has worked on to date. The pathway to developing and manufacturing CGTs is anything but straight and is typically filled with roadblocks and challenges than can include patient-to-patient variability, manufacturing times, clinical site onboarding, regulatory challenges, supply chain constraints, and high costs of goods. In an autologous cell therapy setting where one batch equals one patient, these challenges are exacerbated by the high number of batches that need to be manufactured to treat patients.

In this webinar, we will discuss key industry challenges and their solutions, including new trends and novel processes that address the unique challenges of CGT development. At ElevateBio, we take the approach of building the process for the product to ensure the process is fit for purpose and considers late stage and ultimately commercial manufacturability.

Attend this webinar for insights into:

The current industry-wide challenges faced by companies developing CGTs, and more specifically autologous cell therapies
The cell therapy toolbox and the decisions that need to be considered when developing a cell therapy process
The solutions that ElevateBio is working on – such as a shortened CAR-T cell process and supporting analytics
How the right development and manufacturing partner can help straighten the line for developing and manufacturing cell therapies for patients

Jeff Cram

Senior Director at ElevateBio

Jeff is a seasoned professional with a rich background in cellular process development and manufacturing, contributing significantly to the advancement of novel cell therapies. Currently serving as the Senior Director of Cellular Process Development at ElevateBio, he has been instrumental in the development and scale-up of first-in-human novel cell therapies. His expertise encompasses initiating, scaling up, validating, and manufacturing cellular therapies for clinical applications.

Prior to his role at ElevateBio, Jeff made notable contributions during his time at bluebird bio, where he held positions as Scientist II and Senior Scientist. His work involved the development of cellular therapies and viral vector transduction, among other projects, contributing to the evolution of cutting-edge cellular therapies.

Jeff's career journey also includes a pivotal role at the Dana-Farber Cancer Institute, where he served as a Project Leader II for nearly a decade. In this capacity, he led a diverse team in the initiation, scale-up, validation, and manufacture of first-in-human novel cell therapies. His work spanned various protocols, including tumor vaccines and cellular assays, showcasing his ability to transfer technology from research to clinical application.