Aldevron Breakthrough Blog

Raw materials in the spotlight at Cell & Gene Therapy World 2017

Cell-Gene-2017-blog.jpgExcellent scientific talks and great weather were on tap when I attended the 2017 Cell & Gene Therapy World in Miami in January. Ed Field from BioRestorative Therapies started off with the top events of 2016, which was populated with some sizable deals.

This suggests cell and gene therapy continues to attract investment, and that expectations for approved products will be met very soon, perhaps in 2017. This set the tone for an exciting and productive meeting, as companies and academic institutions both continue to push the envelope in manufacturing 

Several companies showed data using the iCellis Bioreactor from Pall Corporation and the yields are impressive. CEVEC continues to develop its CAP-GT cell line for viral vector production, showing improved performance. Some companies are pursuing stable cell lines, showing the importance of raw materials and cell substrates in gene therapy manufacturing. 

Strategies and control
At the event, I was a member of the manufacturing section, "Adapting to increased emphasis on traceability, transparency and control of starting and raw materials". Our panel discussion, "Raw materials as a critical component of your business strategy", was a great learning experience for participants and audience alike.

Dr. Dominic Clarke from Charter Medical Ltd. chaired the session and facilitated conversation about several important topics. Marlin Frechette from Irvine Scientific and Jeremy Kolenbrander of Terumo BCT both gave engaging presentations on what they are seeing from clients and regulatory authorities concerning raw materials. They were joined on the panel by Dr. Knut Niss from Biogen and me 

Analytics and CMOs
One of the conclusions from the discussion was the importance of analytics. Choosing the proper quality control assays with relevant specifications can make or break your production runs. I discussed the advantage of Aldevron's different quality grades, from research through clinical and commercial, is that the assays are consistent and specifications are met at all quality levels.  

Joe Hughes from Wuxi was in the audience and mentioned the importance of CMOs in the supply chain working with other manufacturers on assay development. In many cases, the CMO that produces the API must perform QC tests on raw materials, and it is important for the CMO and the supplier to share information on assay procedures and specifications. 

Thanks to all the clients who stopped by the booth. Tanner Dockendorf, Ally Hauser and I enjoyed many productive conversations. See you in 2018 back in Miami! 

About the author

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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: Manufacturing, cell therapy, gene therapy