Aldevron Breakthrough Blog

Advancing Opportunity in Cell-based Immunotherapy

Both immunotherapy and regenerative medicine are experiencing explosive growth.  It was a pleasure to learn about the advancements in these fields at two excellent conferences, the CAR-TCR Summit organized by Hanson Wade, and the Cell and Gene Meeting on the Mesa sponsored by the Alliance of Regenerative Medicine.

The approvals of Kymriah from Novartis and Yescarta from Kite and Gilead have generated a lot of enthusiasm for cell-based immunotherapy. The innovative scientists and engineers at these companies are meeting the challenging manufacturing requirements for these treatments. As an example, Gilead managed a manufacturing success rate of 99 percent with a median 17-day turnaround time. 

Of particular interest at the CAR-TCR summit was the fireside chat including Phil Gregory from Bluebird, Laurence Cooper from Ziopharm, James Noble from Adaptimmune, André Choulika from Cellectis and Samuele Butera from Novartis. The variety of approaches to immunotherapy were on display, from viral delivery to direct DNA and gene editing. Aldevron is fortunate to work with the leading organizations in the field and be the basis for some amazing breakthroughs.

The race to commercialization was evident for many of the companies presenting and in attendance at the Cell and Gene Meeting on the Mesa. Quite a bit of discussion centered around how to scale, and regulatory requirements. These are driving manufacturing developments as companies seek to solidify supply chains in preparation for approval and entry into the marketplace.

I was fortunate to be able to participate in a workshop on Manufacturing Gene Medicines chaired by Chris Murphy of Brammer Bio with distinguished colleagues Rob Kotin of the University of Massachusetts and Mark Plavsic of Lysogene. Together, we discussed important factors including dose planning and ensuring a reliable supply of drugs

We also touched on what opportunities are available to improve manufacturing in later phases of development. In many ways, these are great challenges to have as it means that the transformative therapies under development are well on their way to patients. You can watch more of our discussion in the video below.

Spending the last decade in the gene therapy industry has been at times a tumultuous ride with many highs and lows. The tenacity with which the dedicated scientists in the field have pursued these treatments is incredibly impressive. The motivation becomes clear as you listen to the stories of patients and their families affected by these therapies, as they share how their lives have changed. 

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James Brown, Ph.D.

James Brown, Ph.D.

James Brown has over 25 years of biotechnology industry experience, and has spent the last decade in gene and cell therapy. In 2015 he joined Aldevron where he serves as Vice President, Corporate Development and Chief of Staff. His responsibilities include developing and implementing strategies for expanding Aldevron’s products and services. In this capacity he heads the product management function, which expands existing product features and develops new products. As Chief of Staff Brown works with the CEO to execute on his strategic priorities. Prior to joining Aldevron, Brown was Vice President, Technical Operations, at REGENXBIO Inc., a gene therapy company. In this role he was responsible for contract manufacturing, vendor management, operations, quality assurance and biological reagent sales. Prior to REGENXBIO Dr. Brown served in roles of increasing responsibility in operations and quality assurance at MedImmune, Meso Scale Discovery and IGEN International, Inc. Brown holds a Ph.D. in chemistry from Stanford University and a B.S. in chemistry from Butler University.

Topics: Events, Immunotherapy