Aldevron Breakthrough Blog

The Distinction Between Development and Manufacturing is Becoming Blurred


Last month, I participated in a panel discussion at the Rejuvenation Biotechnology 2016 Conference sponsored by the SENS Research Foundation at the Buck Institute for Research on Aging in Novato, California. The title of our panel was "As Paths To Clinic Are Expedited, The Distinction Between Development And Manufacturing Is Becoming Increasingly Blurred".

One of the panelists was Alan Moore, Vice President and Commercial Chief for Biologics and Advanced Therapies of Wuxi AppTec. Alan and I have known each other for some time and it was great to reconnect with him. His presentation covered the impressive work that Wuxi has done in autologous cell processing.

The logistics and timelines for isolating cells from a patient, processing them, and then shipping them for readministration are incredible. Cells that are processed at Wuxi at noon are in the patient at 2 PM. Now that's a supply chain!

The other panelist was Sean Kevlahan, Chief Executive Officer and Co-founder of Quad Technologies. They have developed QuickGel, which allows the viable decoupling of a cell from a substrate--not an easy task. This allows high-throughput cell separation with reduced loss over traditional techniques. This technology will help advance a wide variety of cell therapies.

I was able to discuss how Aldevron is working with clients and regulators to ensure critical raw materials are available for gene and cell therapy development. These products are challenging to produce, both from a timeline and cost perspective.

Aldevron has developed quality levels for plasmid DNA, proteins, and enzymes that are tailored to product requirements from research through clinical applications, thereby reducing costs and timelines for production, development and manufacturing.

The panel video is available below. Let us know what you think in the comments below or contact us today to learn more.

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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.

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